Clinical trials

This randomized, double-blind, sham-controlled clinical trial investigates how the timing of transcranial direct current stimulation (tDCS) influences functional recovery during acute stroke rehabilitation. 198 hospitalized patients with confirmed acute stroke will be randomly assigned to one of three groups. Each day, all participants will receive three tDCS sessions: one before, one during, and one after their rehabilitation session. In each group, only one of these three daily stimulations is active, while the other two are sham, allowing a direct comparison of timing effects while maintaining blinding. All participants will complete 2 sets of five consecutive days of conventional rehabilitation combined with the tDCS protocol (2 weeks). Functional, sensory, psychological, and motor outcomes will be assessed at baseline and at the end of the intervention week. The study aims to determine whether the timing of tDCS application influences early post-stroke recovery and to inform the design of future confirmatory trials.

Chronic ankle instability (CAI) is a common condition that can develop after a lateral ankle sprain. Up to 40% of people who sprain their ankle experience a recurrence within a year, and as many as 30% develop persistent symptoms such as ankle "giving way," weakness, or instability. These symptoms can limit daily activities, sports participation, and increase the risk of future sprains. Muscle weakness in both the ankle and hip has been identified as an important factor contributing to CAI. Strengthening these muscles may therefore help improve stability and function. The SHAC study is a randomized controlled trial designed to compare three different strengthening programs in people with chronic ankle instability: (1) an ankle-focused strengthening program, (2) a hip-focused strengthening program, and (3) a combined ankle-hip strengthening program. The goal is to determine which approach leads to the greatest improvement in functional ability, muscle strength, balance, and ankle mobility. A total of 45 participants aged 18 to 35 years with documented chronic ankle instability will be recruited from local sports clubs and the University of Liège. All participants must have a history of at least one ankle sprain that occurred more than 12 months before entering the study, report episodes of ankle instability in the previous six months, and meet specific questionnaire criteria (CAIT \< 24 and FAAM Sport \< 80%). People with recent injuries, previous lower-limb surgery, fractures requiring realignment, neuromuscular conditions, or current pain or swelling will not be able to participate. After the first assessment (T1), participants will be randomly assigned to one of the three groups. Each intervention lasts four weeks and includes three supervised sessions per week. All strengthening exercises are isometric, performed using a handheld dynamometer to measure force accurately. The ankle program includes plantarflexion, dorsiflexion, inversion, and eversion exercises. The hip program includes clamshells, hip external rotation, abduction, and extension. The combined group alternates between hip and ankle exercises. A warm-up and standardized familiarization are performed before each session. All participants will attend two additional assessment sessions: one immediately after the four-week program (T2) and one at a later follow-up time point (T3). During each visit, they will complete functional questionnaires, report their sports participation, and undergo several strength and performance tests. These include hip and ankle muscle strength measurements using a dynamometer, the Heel Rise Test, the modified Y-Balance Test, the Side Hop Test, and a dorsiflexion mobility test. The study aims to identify whether one of the strengthening approaches leads to better functional outcomes for individuals with chronic ankle instability. Understanding these effects may help clinicians design more effective rehabilitation programs for people recovering from ankle sprains and for those experiencing ongoing instability. Participant data will be kept confidential and stored securely in anonymized form for 20 years. Participation is voluntary, and individuals may withdraw at any time without consequences. Results will be presented anonymously in scientific publications and conferences.

This prospective single-center observational pharmacokinetic study will evaluate plasma levobupivacaine concentrations after ultrasound-guided transversus abdominis plane (TAP) block in adult patients undergoing elective abdominal surgery under general anesthesia at CHU Liège. Participants receiving TAP block as part of standard clinical care (levobupivacaine 0.375%, total volume 40 mL, maximum dose 150 mg) will undergo serial blood sampling at 3, 7, 15, 30, 60, 120, and 180 minutes after block completion. Plasma levobupivacaine concentrations will be measured using validated LC-MS/MS methods. The primary objectives are to estimate maximum plasma concentration (Cmax) and time to maximum concentration (Tmax). Secondary objectives include characterization of the concentration-time profile, AUC0-180, interindividual variability, and exploratory associations with clinical factors (age, sex, BMI, type of surgery). The study also aims to inform a pragmatic safety window for subsequent intravenous lidocaine infusion used in multimodal analgesia protocols. Approximately 26 participants will be enrolled. No modification of routine anesthesia or analgesic care is required apart from study-related blood sampling.

Background: In recent years, regional anesthesia has become more popular because it can reduce pain and the need for strong pain medications like morphine. For hip surgery, the PENG block is already known to be effective. A newer method, called the iliopsoas plane block (IPB), is very similar and has also shown good results in hip arthroscopy. However, these two techniques have never been directly compared in patients undergoing hip replacement surgery using the posterior approach. Goal: This study aims to see if the IPB is just as effective as the PENG block for controlling pain and helping patients recover well after hip replacement surgery. Method: 118 adult patients scheduled for hip replacement under spinal anesthesia will be randomly assigned to receive either: IPB: 7 ml of Ropivacaine 7.5 mg/ml PENG: 14 ml of Ropivacaine 3.75 mg/ml Both injections are given under ultrasound guidance 30 minutes before spinal anesthesia. Neither the patient, the surgeon, nor the data collector will know which technique was used. Post-Surgery Care: All patients will receive standard pain relief, including: Paracetamol every 6 hours Etoricoxib once a day Morphine via a patient-controlled pump for 48 hours Main Outcome Measured: The primary goal is to compare pain during movement 6 hours after surgery, using a pain scale from 0 (no pain) to 10 (worst pain). The study will consider the two blocks equivalent if the difference in average pain scores is less than 1 point. Other Outcomes: Total morphine used in 48 hours Pain scores at rest and during movement at various time points Walking ability (2- and 6-minute walk tests, and timed-up-and-go test) Quality of recovery (using the QoR-15 questionnaire) Side effects of morphine Patient satisfaction Length of hospital stay Safety: Both techniques are safe and already used in clinical practice. Ultrasound guidance minimizes risks like nerve injury, bleeding, or infection. Conclusion: If the IPB is shown to be as effective as the PENG block, both can be considered reliable options for pain control and early recovery after hip replacement surgery.

The aim of this study is to identify the factors associated with successful rehabilitation following hip arthroscopy for femoroacetabular impingement syndrome and to highlight any persistent functional deficits at different key stages of rehabilitation. This is a controlled multi-observational study. The pathological hip of patients will be compared to their second healthy hip as well as to a healthy control group. Assessments of mobility, strength, functional tests, and questionnaire submissions will take place before the intervention and 3 and 6 months after the intervention.

Anterior cruciate ligament (ACL) injuries are common in female soccer and frequently occur during change-of-direction (COD) movements without contact. Biomechanical deficits during these movements are considered important risk factors. This study aims to evaluate the effects of a targeted injury-prevention program on biomechanical movement quality and performance during change-of-direction tasks in female soccer players. Participants will perform a 90° cutting task during which biomechanical movement quality will be assessed using the Cutting Movement Assessment Score (CMAS), while performance will be evaluated using cutting time measured with photoelectric timing gates. Participants will also perform the 505 Agility Test to assess additional change-of-direction performance. In addition, subjective perceptions of functional confidence and performance will be collected using Likert-scale questionnaires. The study will assess whether a structured prevention program integrated into regular training can improve biomechanical movement patterns and change-of-direction performance.

The effects of regular exercise on asthma control has not yet been well demonstrated. The aim of this study is to investigate the impact of submaximal aerobic training on exercise tolerance (VO2max - primary outcome) and a set of secondary outcomes: quality of life, asthma symptoms control, bronchial and systemic inflammatory markers, lung function, bronchial hyperresponsiveness, anxiety and depression and body composition in patients with persistant asthma.

This study investigates whether using 3D imaging technology (Cone Beam Computed Tomography or CBCT) for orthodontic treatment planning with aligners can reduce the risk of gingival recession in adult patients seeking dental arch expansion. Many aligner treatments involve expanding the dental arches to address issues like crowding and "black corridors," but this can sometimes lead to gum recession. The research compares two groups of patients: one group will have their treatment planned using CBCT, which allows for detailed 3D visualization of the teeth and bone structure, while the other group will follow a conventional 2D treatment plan. The goal is to see if the 3D tool helps prevent gum recession and other periodontal problems like bone thinning, as well as to assess the impact on other factors like upper airway dimensions. The study is a randomized controlled trial with 40 participants. It will track changes in gum health, bone structure, and airway volume over the course of treatment. The researchers aim to find out if the advanced imaging tool provides significant benefits compared to traditional planning methods.

According to the scientific literature, public speaking (PS) is an important skill for students to master. However, a large proportion of students do not feel comfortable speaking in public. PS anxiety impacts oral communication (i.e., voice and fluency). These changes can affect speaker's academic and professional success, as well as his credibility. Performing a high-quality PPP with confidence is therefore rarely an innate skill, but fortunately it can be trained and improved. Therefore, training PS skills in representative settings is crucial but often challenging for PS professionals (e.g., speech therapists, vocologists, coaches). This project examines how oral communication skills training including simulations in virtual reality (VR) supports the acquisition of effective oral PS skills. Using acoustic analyses, outcomes from participants in the intervention group (N = 40) will be compared with those of a wait-list control group (N = 40) to determine whether significant differences emerge in filled pauses, speech rate, and vocal intonation during PS. Changes in PS self-efficacy will also be assessed. Regarding secondary outcomes, the study will evaluate changes in self-reported and physiological PS anxiety, as well as self-reported confidence as a speaker. Finally, self-perceived vocal effort during PS will be examined.

The project aims to optimise functional rehabilitation programmes for people with multiple sclerosis. Investigators are proposing eccentric cycling as a new exercise modality for treating these patients. Based on previous results in healthy subjects, investigators will attempt to define the optimal parameters of this new modality (in terms of duration, intensity, frequency, etc.). Investigators also aim to demonstrate the effectiveness of this training (compared to conventional training) in improving muscle function, functional capacity, perception of chronic fatigue, quality of life, physical condition, and neurological and cognitive function.

The first objective of this study is to compare cardiometabolic and mental health across the four interregion Meuse-rhine (IMR). The second objective is to compare six key lifestyle pillars, as defined by the American College of Lifestyle Medicine: physical activity, diet, stress management, sleep quality, social connection, and substance use. Physical activity will be objectively and continuously monitored using a wearable device, while the other five lifestyle factors will be assessed through validated questionnaires at pre- and postintervention. Finally, we will evaluate the effects of a physical activity intervention on cardiometabolic health, mental health, and the six lifestyle pillars. By addressing these objectives, this study aims to generate valuable insights to inform policymakers and support region-specific interventions for improving health and lifestyle across the IMR. This multicentric interventional study will be conducted at four sites: Hasselt University, Liège University, Maastricht University, and Aachen University. The study includes a pre- and post-intervention visit, with a three-month intervention period followed by a three-month follow-up. Participants will be recruited via a subscription link, where they will provide demographic information after giving informed consent. Based on the inclusion criteria, 1000 participants will be included in total (250 participants per site). Ethical approval documents for the two sites in Belgium will be submitted simultaneously. Documents for Maastricht University and Aachen University will be submitted afterward, and the ethical approvals will be sent to the Belgian ethical committees. A quota for educational level will be implemented, limiting highly educated participants to a maximum of 25% per region to reflect the educational distribution of the IMR population. This ensures a more representative sample, as highly educated individuals are often overrepresented in research. To minimise seasonal effects on physical activity, participant inclusion will be divided into four groups and spread throughout the year. At each site, approximately 65 participants will start in September 2025, another group in December '25/January '26, a third group in March/April '26, and a final group in June/July '26. Participants will be recruited through online and paper advertisements, including a subscription link to the screening questionnaire. Selected participants will receive detailed study information via phone or email, based on their indicated preference. Data from unselected participants will be deleted after recruitment is completed. Those who agree to participate will be invited for a first study visit, where they will provide written informed consent. Selected participants may withdraw at any time for any reason. In such cases, previously collected research data will be retained, but contact details will be deleted, and their name will be removed from the subject identification list. During the first study visit, all study procedures and outcome measures will be explained, and participants will provide written informed consent. Next, they will complete questionnaires on their sociodemographic factors, mental health and lifestyle factors using an iPad or computer. These questionnaires will be accessed via a secured link sent by the EDC Castor system to a fictitious email address created in advance for each participant. A member of the research team will prepare the questionnaires for each participant and verify their correct submission afterward. Following this, blood pressure and anthropometric measurements will be taken, and a venous blood sample will be drawn by a certified nurse or doctor. Participants will then receive their wearable along with assistance for installation and connection to their smartphone. Additionally, a subsample of participants (n = 75 per site) will be asked to install M-Path on their smartphone for ecological momentary assessment of mental health. Technical support will be provided as needed. The same measurements will be repeated during the post-intervention study visit. For sociodemographic factors, participants will be asked if any changes have occurred and, if so, to specify them. In addition, participants will have to answer four questions on intervention adherence and possible barriers they experienced. Statistical analysis will be performed using IBM SPSS Statistics (version 28.0.1.1, IBM Corp., Armonk, NY, USA).

This randomized crossover study evaluates the effects of left paratracheal pressure, cricoid pressure, and no pressure on glottic visualization during videolaryngoscopy in adult surgical patients. The primary endpoint is the Percentage of Glottic Opening (POGO) score assessed by blinded video review. Secondary endpoints include anatomical measures (glottic surface area, vertical and horizontal displacement of the glottic plane) and clinical outcomes (first-pass success, first-pass success without desaturation \<90%, intubation time, Intubation Difficulty Scale, hypoxemia, hemodynamic events, airway trauma, and postoperative sore throat or dysphonia). All outcomes are collected from routine anesthetic practice and video analysis, with no additional procedures.

This single-center observational study aims to describe the incidence of episodes of connected consciousness and disconnected consciousness (including near-death experience (NDE) and out-of-body experiences) in patients who survived a prolonged stay of at least 7 days in the intensive care unit (ICU) and who had at least one episode of pharmacological or non-pharmacological coma. The investigators are also investigating the risk factors related to these episodes of consciousness. A follow-up at six months aims to explore the long-term psychological implications of these episodes.

Persistent post-concussive symptoms (PPCS) affect a significant proportion of individuals following a concussion, leading to debilitating impacts on their quality of life and work capacity. Currently, effective treatments for PPCS are limited, despite their lasting and debilitating impact. Transcutaneous auricular vagus nerve stimulation (taVNS), a non-invasive neuromodulation technique, holds promise as a therapeutic option by leveraging the bottom-up modulation of brain activity via the auricular branch of the vagus nerve. This study aims to evaluate the neurophysiological and clinical effects of taVNS on brain activity and symptomatology in patients with PPCS through a randomized, controlled, double-blind trial.

The aim of this study is to learn about the incidence and risk factors of nausea and vomiting during planned caesarean section under spinal anesthesia. The main question it aims to answer is : What are the incidence and risks factors of postoperative nausea and vomiting (NV) during planned caesarean section under spinal anesthesia with administration of intrathecal morphine and multimodal antiemetic prophylaxis ? Patients who will be managed according to the standard protocol in use in the department will have to answer specific questions about NV in the post-interventional recovery room and on 2 further visits in the first 24 hours post-caesarean section.

Background: Patients who survive severe brain injury may develop chronic disorders of consciousness (DoC). Treating these patients to improve recovery is extremely challenging because of scarce and inefficient therapeutical options. Among pharmacological treatments, apomorphine, a potent direct dopamine agonist, has exhibited promising behavioral effects, but its true efficacy and its mechanism remains unknown. This randomized controlled study aims to verify the effects of apomorphine subcutaneous infusion in patients with disorders of consciousness and investigate the neural networks targeted by this treatment. Methods/design: The double-blind randomized controlled trial will include 48 patients: 24 patients will be randomly assigned to the apomorphine and 24 to the placebo group. Investigators and the patients will be unaware of the nature of the treatment rendered. Primary outcome will be determined as behavioral response to treatment as measured by changes of diagnosis using the Coma Recovery Scale - Revised (CRS-R), while secondary outcome measures will include the Nociception Coma Scale - Revised (NCS-R), Disability Rating Scale (DRS), Wessex Head Injury Matrix (WHIM), circadian rhythm using actimetry, electroencephalography (EEG), positron emission tomography (PET) and functional magnetic resonance imaging (fMRI). The Glasgow Outcome Scale - Extended (GOS-E) and a phone-adapted version of the CRS-R will be used for long-term follow-up. Statistical analyses will focus on the detection of changes induced by apomorphine treatment at the individual level (comparing data before and after treatment) and at the group level (comparing responders with non-responders). Response to treatment will be measured at four different levels: 1. behavioral response (CRS-R, NCS-R, DRS, WHIM, GOS-E, phone CRS-R), 2. brain metabolism (PET), 3. network connectivity (resting-state fMRI, clinical EEG and high-density EEG) and 4. Circadian rhythm changes (actimetry, body temperature, 24h-EEG). Discussion: Apomorphine is a promising and safe strategy for the treatment of DoC but efficacy, profile of the responding population and underlying mechanism remain to be determined. This trial will provide unprecedented data that will allow to investigate the response to apomorphine using multimodal methods and shed new light on the brain networks targeted by this drug in terms of behavioral response, functional connectivity and metabolism.

The goal of this interventional study is to assess the efficacy of a therapeutic intervention aimed at diminishing pediatric chronic headache. This intervention is based on the development of relaxation skills, particularly the practice of deep breathing, using virtual reality in conjunction with a biofeedback device. Specifically, it aims to assess the relevance of this tool both in learning relaxation techniques and in changing cognitions involved in pain adjustment, such as self-efficacy and pain catastrophizing. The main hypothesis is that the intervention using virtual reality will lead to greater daily use of the relaxation techniques learned, as well as an increase in the associated self-efficacy, resulting in a reduction in headaches (in terms of frequency and intensity) both immediately after the intervention and two months later. A secondary hypothesis is that this intervention will contribute to a decrease in negative pain perceptions, pain catastrophizing, and functional disability. A tertiary hypothesis is that the intervention will lead to an improvement in the child's quality of life. The effects of this intervention will be compared to those of a similar intervention without the use of virtual reality, as well as to a control condition in which only psychoeducation is provided.

The goal of this observational study is to assess the impact of imaging modality (trans-thoracic echo (TTE) vs trans-esophageal echo (TEE)), anesthesia and positive pressure ventilation on the grading of aortic insufficiency. Patients scheduled for cardiac surgery and in whom a TEE is going to be performed intra-operatively will be enrolled. The grading of the aortic insufficiency will be compared between a TTE performed immediately before the induction of general anesthesia end the TEE performed after induction of general anesthesia.

The renal biopsy (RB) represents the gold-standard for the diagnosis of acute renal transplant rejection (AR), and allows early verification of a so-called "subclinical" rejection, ie without any clinical or biological abnormality detectable in a stable kidney transplant patient. The RB also makes it possible to certify a strictly normal renal histology and thus to motivate the withdrawal of corticosteroid therapy. It is this 3-month post-transplant protocol RB protocol that has been effective since 2007 at the CHU Liège. However, RB is an invasive procedure, contraindicated in patients taking anticoagulants, and carrying a significant risk of complications. The potential complications associated with RB motivate the identification and validation of other diagnostic means. In the present project, the investigators propose to study the relevance of positron emission tomography (PET), coupled with conventional tomography (CT), after intravenous injection of 18-fluoro-deoxy-glucose (18FDG) in the overall protocol of the renal transplant patient at 3 months post-transplant to: (i) allow protocol renal biopsy only in patients with suspicion of an acute rejection (ii) be a decision maker for withdrawal from corticosteroids in the absence of rejection In practice, the investigators suggest performing 18FDG PET / CT imaging on the day of the surveillance biopsy, which is systematically performed in all kidney transplant patients at University Hospital of Liège 3 months after transplant. The investigators are considering 3 scenarios: * Scenario 1. The renal biopsy shows signs of humoral rejection: the patient is excluded from the study and is treated "as usual" on the basis of the histological results. * Scenario 2. The renal biopsy does not show signs of humoral rejection but the 18FDG PET / CT shows a high metabolic activity of the graft (\> 2.4): the patient is treated "as usual" on the basis of histological findings. * Scenario 3. The renal biopsy does not show signs of humoral rejection and the 18FDG PET / CT shows a weak metabolic activity of the graft (\<2.4): the immunosuppressive treatment is gradually weaned off corticosteroids. This clinical research project is interested in a major health problem in the follow-up of renal transplant patients, and could make it possible to improve the management of a subclinical rejection of the renal transplant and to increase the withdrawal of corticosteroids including side effects are well known.

A psychoneurological symptom cluster is increasingly documented in oncology. It is composed of cancer-related fatigue, sleep difficulties, pain, emotional distress, and cognitive difficulties. These symptoms are linked by strong but complex relationships, and reinforce each other, negatively impacting patients' quality of life and survival. The configuration of this cluster (i.e., the relationships between the symptoms) seems different according to the cancer diagnosis or moment in the cancer journey. It has however been very little studied. Network analysis is an innovative method that allows a deeper understanding of the interactions between these symptoms. It also allows to compare patterns of clustering between distinct populations or measurement times. Finally, it allows to determine one core symptom in a cluster (i.e., the one with the strongest associations with the other symptoms), which could represent a target of choice for interventions aiming to improve the whole symptom cluster. This innovative project has then two main goals. First, the investigators will assess the evolution of the psychoneurological symptom cluster in two populations of patients with cancer: women with breast cancer, and patients with digestive cancer, over two years. Second, the investigators will test the feasibility and preliminary benefits of a new mind-body group intervention specifically designed to address the core symptom of the cluster, determined with network analysis in each population. As suggested by many authors, the proposed intervention will be based on the common-sense model of self-regulation developed by Leventhal and focus on cognitive-behavioral, self-care and mind-body (i.e., hypnosis) empowering strategies. The aim is to assess the satisfaction of the participants regarding the intervention, as well as its impact on the symptoms involved in the cluster.

The port-catheter (PAC) is a longterm venous access device, frequently used in oncology patients. The PAC is an invasive technique, consisting of a reservoir surgically implanted in the chest wall or upper arm, and arm and a catheter. Patients can experience pain in the incision area after implantation, as well as anxiety before, during and after implantation. Virtual reality hypnosis (VRH) is an innovative technique delivering clinical hypnosis to patients through virtual reality (VR). The clinical applications of VRH are still little known. We will assess the anxiety, comofrt, pain perception and pain unpleasantness of 102 cancer patients scheduled to receive a PAC. The patients will be randomly divided into two groups. Thefirst group will benefit from the usual care for the placement of the PAC (i.e., local anaesthesia), while the second will benefit from the VRH in addition to the usual care. Pain perception, pain unpleasantness, anxiety, satisfaction, absorption, dissociation will be evaluated before and after the intervention.

The investigators project is based on: * Assessment of bone architecture by high resolution peripheral scanner (HRpQCT) and bone densitometry (DEXA); * The non-invasive detection of vascular calcifications (by abdominal CT scanner) and bone abnormalities associated with kidney transplantation, as well as the analysis of evolution over time; * Longitudinal evaluation of nephrological clinical parameters (glomerular filtration rate, number and type of rejections, immunosuppressive medications) as well as biological and urinary parameters of mineral metabolism (parathormone, sclerostin, bone alkaline phosphatase) depending on the type and severity of bone abnormalities; * The evaluation of these nephrological clinical parameters and of the biological parameters of mineral metabolism depending on the extent and evolution of vascular calcifications but also on bone morphology; * The study of possible relationships between bone mass and muscle mass (and functioning)

The main objective is to assess the efficacy of local injection of MSC on the healing of refractory intestinal and perianal lesions in crohn disease. The second co-primary endpoint is safety.

This observational study aims to describe the incidence of episodes of disconnected consciousness (including near-death experience (NDE)) and episodes of connected consciousness in patients admitted to the resuscitation room, who survived a critical condition and who meet at least one of these criteria during their stay in the resuscitation room: (1) deep sedation, (2) intubation, (3) cardiopulmonary resuscitation, or (4) (non-drug-induced) Glasgow Coma Scale score = 3. We also investigate the potential (neuro)physiological markers and biomarkers. In order to help determine the potential risk factors of such episodes, cognitive factors such as dissociative propensity are also investigated. Unexpected visual and auditory stimuli will be displayed. In addition, we assess the evolution of memory, as well as short- and long-term consequences on quality of life, anxiety, and attitudes towards care. Memory of patients who did not meet the above-mentioned criteria are also investigated. A group of 15 healthy participants will be invited to test the stimuli display. Finally, (neuro)physiological parameters of a subsample of dying patients are also investigated.

Background: A lot of children with cancer suffer from emotional distress, fatigue and relational difficulties. Their parents are also impacted by the disease: their responsibilities increase and they can feel more distressed and tired. Different psychological interventions designed for ill children and their parents seem to be efficient to improve their social functioning, coping strategies and well-being. However, more research is needed in this field. Hypnosis is often used in paediatric oncology, mostly to decrease procedure-related pain and distress. It has been used efficiently to improve the well-being of adults with cancer. This paper describes a pilot study designed to assess the feasibility and interest of a group intervention combining self-care and hypnosis for children with cancer and their parents, and a quasi-experimental protocol aimed at assessing the efficacy of this group intervention to improve the quality of life of children and their parents. Methods: Our pilot study showed that our intervention was feasible and positive for the participants. To test the efficacy of the intervention, two groups will be set up: one with children with cancer and their interested siblings, and one with their parents. Data will be collected for each group before and after the intervention by questionnaires and a semi-structured interview. Discussion: There is a growing interest in hypnosis in oncology settings. The results of this study should improve knowledge about the efficacy of a group intervention combining self-care and hypnosis to improve quality of life of children with cancer and their family.