AnxietyNCT07910136
Pre-Examination Reflexology for Anxiety and Pain During Pelvic Examination
A study testing Pre-Examination Reflexology in people with Anxiety, run by Goni Sintov at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anxiety
- What is being tested?
- Pre-Examination Reflexology
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Singleton pregnancy.
- Gestational age ≥37 weeks.
- Admitted for planned induction of labor.
- First pelvic examination during the current admission.
- Able to provide written informed consent.
Who cannot join
- Active labor with cervical dilation >3 cm and painful contractions.
- Urgent indication for delivery.
- Chronic use of anxiolytic or sedative medications.
- Peripheral neuropathy or foot pathology.
- Inability to complete the anxiety questionnaires.
- Inability to read or understand Hebrew.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Improving the Pelvic Examination Experience: The Effect of Pre-Examination Reflexology on Anxiety and Pain
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.
Read the detailed description
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.
- Conditions
- Anxiety
- Being tested
- Pre-Examination Reflexology
- Keywords
- Reflexology, Pelvic Examination, Anxiety, Pregnancy, Induction of Labor, Pain
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-Examination ReflexologyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Reflexology Group | Experimental | 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. Receives: Behavioral: Pre-Examination Reflexology |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Approximately 15 minutes
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approximately 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goni Sintov
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Goni Sintov, Wolfson Medical Center
- Investigators
- Goni Sintov, MD, Principal investigator, The Edith Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910136
- Sponsor's protocol ID
- WOMC-0147-26
- Other IDs
- 0147-26-WOMC
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yilar Erkek Z, Aktas S. The Effect of Foot Reflexology on the Anxiety Levels of Women in Labor. J Altern Complement Med. 2018 Apr;24(4):352-360. doi: 10.1089/acm.2017.0263. Epub 2018 Feb 23.
PubMed 29474093Yang JM, Li ZQ, Ye H, Wu YL, Long Y, Zhong YB, Luo Y, Wang MY. Effects of foot reflexology massage on pregnant women: a systematic review and meta-analysis of randomized controlled studies. Sci Rep. 2024 Jan 10;14(1):1012. doi: 10.1038/s41598-023-51107-y.
PubMed 38200035Ozturk R, Sevil U, Sargin A, Yucebilgin MS. The effects of reflexology on anxiety and pain in patients after abdominal hysterectomy: A randomised controlled trial. Complement Ther Med. 2018 Feb;36:107-112. doi: 10.1016/j.ctim.2017.12.005. Epub 2017 Dec 12.
PubMed 29458915Blackburn L, Hill C, Lindsey AL, Sinnott LT, Thompson K, Quick A. Effect of Foot Reflexology and Aromatherapy on Anxiety and Pain During Brachytherapy for Cervical Cancer. Oncol Nurs Forum. 2021 May 1;48(3):265-276. doi: 10.1188/21.ONF.265-276.
PubMed 33855996Teh JJ, Campos F, Koczoski A, Valencia T, Rimmer MP, Al Wattar BH. Effectiveness of Virtual Reality for Pain Relief in Procedures Related to Obstetrics and Gynaecology: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. BJOG. 2026 Jun;133(7):1358-1372. doi: 10.1111/1471-0528.70194. Epub 2026 Feb 24.
PubMed 41735173Pain Management for In-Office Uterine and Cervical Procedures: ACOG Clinical Consensus No. 9. Obstet Gynecol. 2025 May 15;146(1):161-177. doi: 10.1097/AOG.0000000000005911.
PubMed 40373312Reddy DM, Wasserman SA. Patient anxiety during gynecologic examinations. Behavioral indicators. J Reprod Med. 1997 Oct;42(10):631-6.
PubMed 9350018US Preventive Services Task Force; Bibbins-Domingo K, Grossman DC, Curry SJ, Barry MJ, Davidson KW, Doubeni CA, Epling JW Jr, Garcia FA, Kemper AR, Krist AH, Kurth AE, Landefeld CS, Mangione CM, Phillips WR, Phipps MG, Silverstein M, Simon M, Siu AL, Tseng CW. Screening for Gynecologic Conditions With Pelvic Examination: US Preventive Services Task Force Recommendation Statement. JAMA. 2017 Mar 7;317(9):947-953. doi: 10.1001/jama.2017.0807.
PubMed 28267862Bloomfield HE, Olson A, Greer N, Cantor A, MacDonald R, Rutks I, Wilt TJ. Screening pelvic examinations in asymptomatic, average-risk adult women: an evidence report for a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2014 Jul 1;161(1):46-53. doi: 10.7326/M13-2881.
PubMed 24979449Qaseem A, Humphrey LL, Harris R, Starkey M, Denberg TD; Clinical Guidelines Committee of the American College of Physicians. Screening pelvic examination in adult women: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2014 Jul 1;161(1):67-72. doi: 10.7326/M14-0701.
PubMed 24979451
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Pelvic Examination Experience: The Effect of Pre-Examination Reflexology on Anxiety and Pain
- ClinicalTrials.gov ID
- NCT07910136
- Acronym / sponsor ID
- WOMC-0147-26
- Conditions
- Anxiety
- Keywords
- Reflexology, Pelvic Examination, Anxiety, Pregnancy, Induction of Labor, Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Goni SintovOther government
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 2 Nov 2026 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reflexology Group | Experimental | Behavioral: Pre-Examination ReflexologyParticipants 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Singleton pregnancy.
- Gestational age ≥37 weeks.
- Admitted for planned induction of labor.
- First pelvic examination during the current admission.
- Able to provide written informed consent.
Key exclusion criteria (6 listed)
- Active labor with cervical dilation >3 cm and painful contractions.
- Urgent indication for delivery.
- Chronic use of anxiolytic or sedative medications.
- Peripheral neuropathy or foot pathology.
- Inability to complete the anxiety questionnaires.
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 |
|---|---|---|
| Pre-Examination ReflexologyA 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. | Behavioural | Reflexology Group |
Primary outcome
Change in maternal state anxiety measured by STAI-S
Time frame: Approximately 15 minutes
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.
Change in maternal state anxiety measured by VAS-Anxiety
Time frame: Approximately 15 minutes
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.
4 secondary outcomes
Pain intensity during the pelvic examination
Time frame: Immediately after the pelvic examination
Patient satisfaction with the pelvic examination
Time frame: Immediately after the pelvic examination
Change in blood pressure
Time frame: Approximately 15 minutes
Change in heart rate
Time frame: Approximately 15 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 29474093Yilar Erkek Z, Aktas S. The Effect of Foot Reflexology on the Anxiety Levels of Women in Labor. J Altern Complement Med. 2018 Apr;24(4):352-360. doi: 10.1089/acm.2017.0263. Epub 2018 Feb 23.
- Background: PubMed 38200035Yang JM, Li ZQ, Ye H, Wu YL, Long Y, Zhong YB, Luo Y, Wang MY. Effects of foot reflexology massage on pregnant women: a systematic review and meta-analysis of randomized controlled studies. Sci Rep. 2024 Jan 10;14(1):1012. doi: 10.1038/s41598-023-51107-y.
- Background: PubMed 29458915Ozturk R, Sevil U, Sargin A, Yucebilgin MS. The effects of reflexology on anxiety and pain in patients after abdominal hysterectomy: A randomised controlled trial. Complement Ther Med. 2018 Feb;36:107-112. doi: 10.1016/j.ctim.2017.12.005. Epub 2017 Dec 12.
- Background: PubMed 33855996Blackburn L, Hill C, Lindsey AL, Sinnott LT, Thompson K, Quick A. Effect of Foot Reflexology and Aromatherapy on Anxiety and Pain During Brachytherapy for Cervical Cancer. Oncol Nurs Forum. 2021 May 1;48(3):265-276. doi: 10.1188/21.ONF.265-276.
- Background: PubMed 41735173Teh JJ, Campos F, Koczoski A, Valencia T, Rimmer MP, Al Wattar BH. Effectiveness of Virtual Reality for Pain Relief in Procedures Related to Obstetrics and Gynaecology: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. BJOG. 2026 Jun;133(7):1358-1372. doi: 10.1111/1471-0528.70194. Epub 2026 Feb 24.
- Background: PubMed 40373312Pain Management for In-Office Uterine and Cervical Procedures: ACOG Clinical Consensus No. 9. Obstet Gynecol. 2025 May 15;146(1):161-177. doi: 10.1097/AOG.0000000000005911.
- Background: PubMed 9350018Reddy DM, Wasserman SA. Patient anxiety during gynecologic examinations. Behavioral indicators. J Reprod Med. 1997 Oct;42(10):631-6.
- Background: PubMed 28267862US Preventive Services Task Force; Bibbins-Domingo K, Grossman DC, Curry SJ, Barry MJ, Davidson KW, Doubeni CA, Epling JW Jr, Garcia FA, Kemper AR, Krist AH, Kurth AE, Landefeld CS, Mangione CM, Phillips WR, Phipps MG, Silverstein M, Simon M, Siu AL, Tseng CW. Screening for Gynecologic Conditions With Pelvic Examination: US Preventive Services Task Force Recommendation Statement. JAMA. 2017 Mar 7;317(9):947-953. doi: 10.1001/jama.2017.0807.
- Background: PubMed 24979449Bloomfield HE, Olson A, Greer N, Cantor A, MacDonald R, Rutks I, Wilt TJ. Screening pelvic examinations in asymptomatic, average-risk adult women: an evidence report for a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2014 Jul 1;161(1):46-53. doi: 10.7326/M13-2881.
- Background: PubMed 24979451Qaseem A, Humphrey LL, Harris R, Starkey M, Denberg TD; Clinical Guidelines Committee of the American College of Physicians. Screening pelvic examination in adult women: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2014 Jul 1;161(1):67-72. doi: 10.7326/M14-0701.
- Individual participant dataSharing planned: No
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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.
Goni Sintov, MD principal investigator
The Edith Wolfson Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-Examination Reflexology in people with Anxiety, run by Goni Sintov 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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 2 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Goni Sintov, MD (+972508599495, goni.sintov@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in maternal state anxiety measured by STAI-S (time frame: Approximately 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07910136, which also lists 10 linked publications.
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 2 Nov 2026.