The Effect of Reflexology on Time to Delivery During Induction of Labor
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWolfson Medical Center
About this trial
This prospective, randomized controlled trial evaluates the effect of reflexology on maternal anxiety, labor duration, and pain in women undergoing labor induction with an extra-amniotic balloon (EAB). Eligible participants are women with a singleton, term pregnancy, cephalic presentation, intact membranes, and a Bishop score \<6, without prior cesarean delivery or contraindications to vaginal delivery.
Participants will be randomized to two groups: an intervention group receiving reflexology by a certified practitioner following EAB placement, and a control group receiving standard care. Maternal anxiety will be assessed using the State-Trait Anxiety Inventory (STAI) before and after the intervention. Labor duration and pain scores will also be recorded.
The study plans to enroll 84 participants over two years. Reflexology is a safe, non-invasive complementary therapy, and this study aims to determine whether it provides measurable benefits during labor induction.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age of ≥18 years
Gestational age of >37 weeks
Vertex presentation
Intact membranes
Disqualifiers
Patients who had undergone a previous cesarean delivery
Patients with a contraindication for vaginal delivery
Patients with a known fetal malformation patients undergoing termination of pregnancy.
Trial design
Design model
Parallel
Treatments tested in this trial
Reflexology
Other interventionReflexology, a complementary therapy rooted in ancient practices, involves applying pressure to specific points on the feet, hands, or ears thought to stimulate nerve pathways, potentially promoting relaxation and reducing stress. Evidence supporting reflexology's role in obstetrics is growing, with studies highlighting its ability to reduce anxiety, alleviate pain, and influence the duration of labor. Moreover, when reflexology was applied during the active phase of labor it was related to a significant reduction in labor pain intensity and improvements in maternal satisfaction.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: reflexology during induction of laborExperimental treatment 1 intervention
Group B: Standard careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Maternal anxiety during labor as perceived by the validated state-trait anxiety index
state-trait anxiety index (STAI-S) questionnaire
Time frame
first STAI questionnaire after recruitment and before induction initiation to assess baseline anxiety. Within 2-10 hours of EAB placement she will fill the second STAI form (similar) and delta STAI score will be calculatedSecondary outcomes
1
Time from Extra-Amniotic Balloon (EAB) placement to balloon expulsion
The time in hours from the documented placement of the extra-amniotic balloon (EAB) to its spontaneous expulsion from the cervix, recorded by clinical staff or self-reported by the patient. This outcome is used to assess progression of cervical ripening during labor induction. Per developmental protocol, all EABs that do not spontaneously expel within 24 hours will be removed by a physician, and this will be recorded.
Time frame
From the time of EAB placement until the time of balloon expulsion, assessed up to 24 hours after placement.2
Time from labor induction to delivery
Time (in hours) from the initiation of labor induction-defined as the time of extra-amniotic balloon (EAB) placement-to the time of delivery (vaginal or cesarean). This outcome will be used to assess the effect of reflexology on the overall duration of labor after induction.
Time frame
From the time of EAB placement until the time of delivery, assessed up to 72 hours after induction initiation.3
rate of vaginal birth within 24 hours from induction
vaginal birth rate within the first 24 hours from induction initiation in both groups
Time frame
24 hours from induction initiation to delivery4
Pain during labor induction as measured by the Visual Analogue Scale (VAS)
Maternal perception of pain will be assessed using the Visual Analogue Scale (VAS), a 10 cm horizontal line ranging from 0 to 10, where 0 represents "no pain" and 10 represents "worst imaginable pain." Each participant will report her pain level at two time points: 1. Baseline (prior to reflexology or standard care), and 2. After the intervention (reflexology group) or within 2-10 hours after EAB placement (control group). The primary pain outcome will be the maximal reported VAS score during the induction process.
Time frame
Baseline before EAB placement and post-intervention or within 2-10 hours after EAB placement.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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