An interventional study of Pre-Examination Reflexology in Anxiety, sponsored by Goni Sintov. Not yet recruiting at 1 site in Israel. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Goni Sintov · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate whether a brief standardized reflexology session administered before the first pelvic examination reduces maternal state anxiety among term pregnant women admitted for induction of labor. The study is a prospective, randomized, controlled trial comparing a 15-minute reflexology session with a 15-minute rest period before pelvic examination. Anxiety, pain during the examination, patient satisfaction, blood pressure, and heart rate will be assessed.
Pelvic examination is commonly performed in women admitted for induction of labor and may be associated with anxiety, discomfort, and anticipatory distress. This prospective, randomized, controlled trial will evaluate whether a standardized 15-minute reflexology session administered before the first pelvic examination can reduce maternal state anxiety.
Eligible participants will be term pregnant women admitted for planned induction of labor who meet the study inclusion and exclusion criteria. Participants must be at least 18 years of age, have a singleton pregnancy at 37 weeks of gestation or more, and undergo their first pelvic examination during the current admission.
Following written informed consent and baseline assessment of anxiety and vital signs, participants will be randomly assigned in a 1:1 ratio to either the reflexology group or the control group. Participants in the intervention group will receive a standardized 15-minute reflexology session performed by a certified reflexologist, focusing on relaxation-related reflex points according to a predefined protocol. Participants in the control group will receive a 15-minute rest period in the same clinical setting. Standard care will otherwise remain identical between groups.
Following the intervention or rest period, participants will complete a second State-Trait Anxiety Inventory-State (STAI-S) questionnaire and Visual Analog Scale for Anxiety (VAS-Anxiety), and blood pressure and heart rate will be reassessed. The pelvic examination will then be performed. Following the examination, participants will report pain intensity using a 10-point Visual Analog Scale and complete a patient satisfaction questionnaire.
The primary outcome is the change in maternal state anxiety from baseline to the assessment immediately before the pelvic examination, measured by STAI-S and VAS-Anxiety. Secondary outcomes include pain intensity during the pelvic examination, patient satisfaction, and changes in blood pressure and heart rate.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 120 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →This is the only study on the registry with Goni Sintov as lead sponsor.
Compared within Pain, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a standardized 15-minute reflexology session performed by a certified reflexologist before the first pelvic examination. The treatment will focus on relaxation-related reflex points according to a predefined protocol.
Behavioral: Pre-Examination Reflexology
Participants will receive a 15-minute rest period in the same clinical setting before the first pelvic examination. Standard care will otherwise remain identical between groups.
A standardized 15-minute reflexology session performed by a certified reflexologist before the first pelvic examination. The treatment will focus on relaxation-related reflex points according to a predefined protocol.
Change in maternal state anxiety measured by STAI-S
Change in maternal state anxiety from baseline to immediately before the pelvic examination, measured using the State-Trait Anxiety Inventory-State (STAI-S) questionnaire. The State-Trait Anxiety Inventory - State (STAI-S) consists of 20 items, with total scores ranging from 20 to 80. Higher scores indicate greater state anxiety and therefore a worse outcome. Anxiety will be assessed at baseline and again after the 15-minute intervention or rest period.
Time frame: Approximately 15 minutes
Change in maternal state anxiety measured by VAS-Anxiety
Change in maternal state anxiety from baseline to immediately before the pelvic examination, measured using the Visual Analog Scale for Anxiety (VAS-Anxiety). The Visual Analog Scale for Anxiety (VAS-Anxiety) ranges from 1 to 10, with higher scores indicating greater anxiety and therefore a worse outcome. Anxiety will be assessed at baseline and again after the 15-minute intervention or rest period.
Time frame: Approximately 15 minutes
Pain intensity during the pelvic examination
Pain intensity during the pelvic examination, measured immediately after the examination using the Visual Analog Scale (VAS), with scores ranging from 1 to 10. Higher scores indicate greater pain intensity and therefore a worse outcome.
Time frame: Immediately after the pelvic examination
Patient satisfaction with the pelvic examination
Patient satisfaction with the pelvic examination, assessed using a patient satisfaction questionnaire immediately after the examination.
Time frame: Immediately after the pelvic examination
Change in blood pressure
Change in blood pressure from baseline to after the 15-minute intervention or rest period and before the pelvic examination. Systolic and diastolic blood pressure will be assessed at both time points.
Time frame: Approximately 15 minutes
Change in heart rate
Change in heart rate from baseline to after the 15-minute intervention or rest period and before the pelvic examination.
Time frame: Approximately 15 minutes
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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