The Effect of Reflexology on Time to Delivery During Induction of Labor
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Reflexology.
- Who it may be relevant to
- Registry conditions: Reflexology, Labor Induction, Extra Amniotic Balloon. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Reflexology Treatment on Maternal Anxiety During Induction of Labor With an Extra-amniotic Balloon
Overview
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.
Interventions
- Other 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 si
Primary outcome measures
- Maternal anxiety during labor as perceived by the validated state-trait anxiety index [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 calculated]
Secondary outcome measures (12)
- Time from Extra-Amniotic Balloon (EAB) placement to balloon expulsion [Time frame: 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 [Time frame: 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 [Time frame: 24 hours from induction initiation to delivery]
- Pain during labor induction as measured by the Visual Analogue Scale (VAS) [Time frame: Baseline before EAB placement and post-intervention or within 2-10 hours after EAB placement.]
- Mode of delivery [Time frame: At delivery]
- Maternal satisfaction with the labor induction experience [Time frame: up to 1 hour from intervention and prior to delivery]
- Intrapartum fever [Time frame: During labor, up to delivery]
- Manual lysis of placenta [Time frame: At delivery]
- Neonatal birthweight [Time frame: At 1 minute and 5 minutes after birth]
- Umbilical cord pH [Time frame: At birth]
- NICU admission [Time frame: Immediately after birth, assessed through hospitalization period (up to 28 days)]
- Respiratory distress syndrome (RDS) [Time frame: During initial hospitalization (up to 28 days of life)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Israel · 1 center
- Edith Wolfson Medical Center — Holon
Identifiers
NCT: NCT07168187 · 0011-25-WOMC