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

NCT ID: NCT07168187

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-30
• Study Completion Date: 2026-08-01

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.

Detailed Description

Labor induction is a common obstetric procedure that can be associated with maternal anxiety, pain, and prolonged labor, potentially affecting the birth experience and maternal well-being. Complementary interventions may help reduce these effects and improve patient satisfaction.

Reflexology is a non-invasive therapy involving targeted pressure on specific points of the feet, hands, or ears, which may promote relaxation and reduce stress and pain. Preliminary evidence suggests reflexology can decrease maternal anxiety and labor pain, but high-quality data in the context of mechanically induced labor are limited.

This study evaluates reflexology during labor induced with an extra-amniotic balloon (EAB). Participants will be randomized to receive either reflexology by a trained practitioner after EAB placement or standard care without reflexology. Maternal anxiety, labor duration, pain, and patient satisfaction will be systematically assessed, using validated measures for anxiety and pain, along with routine clinical and neonatal data collected from hospital records.

The study aims to enroll 84 participants over two years. All participants will provide informed consent, and data will be de-identified to ensure privacy. This trial seeks to provide evidence on the efficacy of reflexology as a complementary intervention during labor induction, informing clinical practice and enhancing maternal-centered care.

Conditions

Reflexology; Labor Induction; Extra Amniotic Balloon

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

reflexology during induction of labor

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.

Group Type: EXPERIMENTAL

Reflexology

Intervention Type: 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.

Standard care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Reflexology

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Wolfson Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Liat Mor, MD

Role: CONTACT

liatmor1@gmail.com

+972546738294

Other Identifiers

0011-25-WOMC

Identifier Type: -

Identifier Source: org_study_id