The Effect of Immersive Virtual Reality and Relaxing Videos on Lung Cancer Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHacettepe University
About this trial
Lung cancer is one of the types of cancer with a high incidence and mortality rate in the world and in our country. Frequently used protocols in the chemotherapy treatment of lung cancer are the Platine-based drugs. The main side effects of this chemotherapy protocols are nausea, vomiting, neutropenia and fatigue. The side effects of cancer and chemotherapy cause patients to experience distress and their quality of life is adversely affected. Some non-pharmacological methods such as meditation, breathing exercises, and massage can be used to manage the symptoms experienced by patients due to chemotherapy for supportive care. One of these methods is the virtual reality applications. In addition, audio-visual (video) therapy methods are other methods that can be used in the symptom management of these patients. In this study, the effect of interactive/imersive virtual reality intervention and relaxant video intervention on symptom severity, distress level and quality of life of patients diagnosed with lung cancer will be evaluated. Patients will be assigned to 3 groups: virtual reality intervention group (VR), relaxant video application group (RV) and control group (CG) by stratified randomization according to the disease stage and dryg type. During the chemotherapy treatment, the patients will take interactive/immersibe virtual reality (VR group) or relaxant video application (RV group) consisting of nature-themed scenarios. The interventions will be done 2 times and about 20 minutes in the first day of each chemotherapy cycles, in total 2 cycles. The control group will receive routine nursing care. Research data will be collected at different intervals during the chemotherapy course with the Patient Information Form (only once), the Edmonton Symptom Diagnosis Scale, the NCCN Distress Thermometer, the European Cancer Treatment and Organization Committee Quality of Life Scale and the Patient Follow-up Form and will be analyzed with the IBM SPSS v.23 program.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
are over 18 years old,
diagnosed with lung cancer,
will receive chemotherapy for the first time,
will receive at least 2 cycles of chemotherapy treatment
Disqualifiers
Having a cognitive and psychiatric disorder and diagnosis,
Having brain metastasis or chronic disease related to the head-brain region,
Having vision-hearing problems,
Having epilepsy, vertigo, chronic severe headache, dizziness problems,
Trial design
Design model
Parallel
Treatments tested in this trial
İmmersive Virtaul Reality Applications
Other interventionTo apply immersive virtual reality applications (Scenarios)
Relaxing Videos
Other interventionTo watch relaxing videos including pictures and sounds prepared by researcher
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Virtual Reality GroupExperimental treatment 1 intervention
Group B: Relaxing Video GroupExperimental treatment 1 intervention
Group C: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Edmonton Symptom Assessment Scale (ESAS)
Changes on overall score of Edmonton Symptom Assessment Scale. The scale is a numerical scale between 0 and 10 developed to measure each symptom level (total 12 symptoms). Lower scores indicate lower symptom levels.
Time frame
First day of each chemotherapy cycle (totally 2 cycles) (2 times in about 21 days, totally 4 times in about 42 days or more)Secondary outcomes
1
National Comprehensive Cancer Network Distress Thermometer (NCCN-DT)
Changes on overall score of Distress Scale. The scale is a numerical scale between 0 and 10 developed to measure stress levels. Lower scores indicate lower stress levels.
Time frame
(Before and after the interventios/for control groups same time -20 mins.-) First day of each chemotherapy cycle (totally 2 cycles) (2 times in about 21 days, totally 4 times in about 42 days or more)2
The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-30)
Changes on overall score of Quality of Life Scale. The scale is a multi-dimesion scale including total 30 questios to measure quality of life level. Minimum score is 0, and maximum score is 100.
Time frame
First day of each chemotherapy cycle (totally 2 cycles) (2 times in about 21 days, totally 4 times in about 42 days or more)Sponsors and contacts
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Source ClinicalTrials.gov