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

Wolfson Medical Center (WMC)

Status: Not yet enrolling

Conditions: Labor Induction; Reflexology; Extra Amniotic Balloon

Treatments: Other: Reflexology

Study type: Interventional

Funder types: Other

Identifiers

NCT07168187

0011-25-WOMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

reflexology during induction of labor

Experimental group

Description:

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.

Treatment:

Other: Reflexology

Standard care

No Intervention group

Description:

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.