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

NCT07168187 | Not Yet Recruiting

• 1 other identifier: 0011-25-WOMC
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Reflexology; Labor Induction; Extra Amniotic Balloon

Keywords

induction to delivery time; labor induction; maternal anxiety

Outcome Measures

Primary Outcomes (1)

• Maternal anxiety during labor as perceived by the validated state-trait anxiety index

  state-trait anxiety index (STAI-S) questionnaire

  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 calculated

Secondary Outcomes (18)

• Time from Extra-Amniotic Balloon (EAB) placement to balloon expulsion

  From the time of EAB placement until the time of balloon expulsion, assessed up to 24 hours after placement.

• Time from labor induction to delivery

  From the time of EAB placement until the time of delivery, assessed up to 72 hours after induction initiation.

• rate of vaginal birth within 24 hours from induction

  24 hours from induction initiation to delivery

• Pain during labor induction as measured by the Visual Analogue Scale (VAS)

  Baseline before EAB placement and post-intervention or within 2-10 hours after EAB placement.

• Mode of delivery

  At delivery

Study Arms (2)

reflexology during induction of labor

EXPERIMENTAL

Participants randomized to this arm will receive a reflexology treatment administered by a certified reflexologist. The session will occur shortly after placement of the extra-amniotic balloon (EAB) for labor induction and before the balloon's spontaneous expulsion or removal at 24 hours. Reflexology will be performed on specific pressure points on the feet, following a standardized protocol intended to reduce maternal anxiety and pain. Participants will also receive routine obstetric care as per institutional protocol.

Other: Reflexology

Standard care

NO INTERVENTION

Participants randomized to this arm will receive standard obstetric care for labor induction with an extra-amniotic balloon (EAB) according to the hospital's clinical protocol. No reflexology or sham procedure will be administered. Anxiety and pain assessments will be conducted at comparable time points to those in the intervention group.

Interventions

Reflexology OTHER

Reflexology, 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.

reflexology during induction of labor

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of ≥18 years
• Gestational age of \>37 weeks
• Vertex presentation
• Intact membranes
• Station of the fetus's head \< S-4
• Bishop score of \<6.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wolfson Medical Center: lead

MeSH Terms

Interventions

Musculoskeletal Manipulations

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Liat Mor, MD

CONTACT

+972546738294; liatmor1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2025
• First Posted: September 11, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share