ReflexologyNCT07168187
The Effect of Reflexology on Time to Delivery During Induction of Labor
A study testing Reflexology in people with Reflexology and Labor Induction, run by Wolfson Medical Center at 1 site in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Reflexology, Labor Induction, Extra Amniotic Balloon
- What is being tested?
- Reflexology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Dec 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Reflexology Treatment on Maternal Anxiety During Induction of Labor With an Extra-amniotic Balloon
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.
Read the 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
- Being tested
- Reflexology
- Keywords
- induction to delivery time, labor induction, maternal anxiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReflexologyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal anxiety during labor as perceived by the validated state-trait anxiety index
state-trait anxiety index (STAI-S) questionnaire
Measured: 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
The time in hours from the documented placement of the extra-amniotic balloon (EAB) to its spontaneous expulsion from the cervix, recorded by clinical staff or self-reported by the patient. This outcome is used to assess progression of cervical ripening during labor induction. Per developmental protocol, all EABs that do not spontaneously expel within 24 hours will be removed by a physician, and this will be recorded.
Measured: 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 (in hours) from the initiation of labor induction-defined as the time of extra-amniotic balloon (EAB) placement-to the time of delivery (vaginal or cesarean). This outcome will be used to assess the effect of reflexology on the overall duration of labor after induction.
Measured: 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
vaginal birth rate within the first 24 hours from induction initiation in both groups
Measured: 24 hours from induction initiation to delivery
Pain during labor induction as measured by the Visual Analogue Scale (VAS)
Maternal perception of pain will be assessed using the Visual Analogue Scale (VAS), a 10 cm horizontal line ranging from 0 to 10, where 0 represents "no pain" and 10 represents "worst imaginable pain." Each participant will report her pain level at two time points:
- Baseline (prior to reflexology or standard care), and
- After the intervention (reflexology group) or within 2-10 hours after EAB placement (control group).
The primary pain outcome will be the maximal reported VAS score during the induction process.
Measured: Baseline before EAB placement and post-intervention or within 2-10 hours after EAB placement.
Mode of delivery
Mode of delivery categorized as spontaneous vaginal delivery, instrumental vaginal delivery, or cesarean section. Data will be obtained from delivery records.
Measured: At delivery
Maternal satisfaction with the labor induction experience
Maternal satisfaction will be assessed using a scale ranging from 1 to 5, where 1 indicates "not satisfied at all" and 5 indicates "maximally satisfied." Participants will rate their satisfaction after the intervention (reflexology or standard care) and before delivery. Higher scores indicate greater satisfaction.
Measured: up to 1 hour from intervention and prior to delivery
Intrapartum fever
Occurrence of maternal intrapartum fever, defined as body temperature ≥38.0°C measured during labor.
Measured: During labor, up to delivery
Manual lysis of placenta
Need for manual lysis of placenta, defined as manual removal of the placenta following delivery.
Measured: At delivery
Neonatal birthweight
Apgar score at 1 and 5 minutes, each ranging from 0 to 10, with higher scores indicating better neonatal condition.
Measured: At 1 minute and 5 minutes after birth
Umbilical cord pH
Arterial umbilical cord pH measured immediately after birth.
Measured: At birth
NICU admission
Rate of neonates admitted to the Neonatal Intensive Care Unit (NICU).
Measured: Immediately after birth, assessed through hospitalization period (up to 28 days)
Respiratory distress syndrome (RDS)
Rate of neonatal respiratory distress syndrome as documented in the neonatal medical record.
Measured: During initial hospitalization (up to 28 days of life)
Neonatal ventilation
Rate of neonates on mechanical or non-invasive ventilation support during the newborn's hospitalization.
Measured: During initial hospitalization (up to 28 days)
Neonatal neurological morbidity
Rate of neonates with diagnosed neurological complications, including seizures or intraventricular hemorrhage (IVH), during neonatal hospitalization.
Measured: During initial hospitalization (up to 28 days)
Neonatal hypoglycemia
Rate of neonates with documented blood glucose <40 mg/dL within the first 24 hours of life.
Measured: Within first 24 hours after birth
Neonatal blood transfusion
Rate of neonates requiring blood transfusion during neonatal hospitalization.
Measured: During neonatal hospitalization (up to 28 days)
Neonatal phototherapy
Rate of neonates admitted for phototherapy for hyperbilirubinemia.
Measured: During neonatal hospitalization (up to 28 days)
Neonatal death
Rate of dead neonates within the first 28 days of life.
Measured: Up to 28 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start30 Dec 2025
- Primary completion7 Jun 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ReflexologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168187
- Sponsor's protocol ID
- 0011-25-WOMC
- Status last verified
- Sep 2026
- First submitted
- 8 Jun 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reflexology Treatment on Maternal Anxiety During Induction of Labor With an Extra-amniotic Balloon
- ClinicalTrials.gov ID
- NCT07168187
- Acronym / sponsor ID
- 0011-25-WOMC
- Conditions
- Reflexology, Labor Induction, Extra Amniotic Balloon
- Keywords
- induction to delivery time, labor induction, maternal anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- 7 Jun 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| reflexology during induction of labor | Experimental | Other: ReflexologyParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age of ≥18 years
- Gestational age of >37 weeks
- Vertex presentation
- Intact membranes
- Station of the fetus's head < S-4
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReflexologyReflexology, 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. | Other | reflexology during induction of labor |
Primary outcome
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
state-trait anxiety index (STAI-S) questionnaire
18 secondary outcomes
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)
Neonatal ventilation
Time frame: During initial hospitalization (up to 28 days)
Neonatal neurological morbidity
Time frame: During initial hospitalization (up to 28 days)
Neonatal hypoglycemia
Time frame: Within first 24 hours after birth
Neonatal blood transfusion
Time frame: During neonatal hospitalization (up to 28 days)
Neonatal phototherapy
Time frame: During neonatal hospitalization (up to 28 days)
Neonatal death
Time frame: Up to 28 days after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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THE EFFECT OF A REFLEXOLOGY PROGRAM ON PREMENSTRUAL SYNDROME SYMPTOMS, QUALİTY OF LİFE AND GENERAL COMFORT
Premenstrual Syndrome-PMS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reflexology in people with Reflexology and Labor Induction, run by Wolfson Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.