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The Effect of Reflexology on Time to Delivery During Induction of Labor

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Trial completed Show 4 more changesShow less
    • Enrollment target: estimated 84 to confirmed 92
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 7 of 18 entries
    • Site details revised
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Primary completion date changed from estimate of Jun 1, 2026 to Jun 7, 2026
    v3
  3. Start date: Sep 1, 2025 to Dec 30, 2025
    • Primary endpoint revised
    • Secondary endpoints: details revised at 9 of 18 entries
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07168187
Lead Sponsor Wolfson Medical Center
Conditions
(from sponsor)		 Reflexology, Labor Induction, Extra Amniotic Balloon
Enrollment 92 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov