Effects of Breastfeeding, Virtual Reality, and Stress Ball on Pain, Anxiety, Cortisol Levels, and… (NCT07510477) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effects of Breastfeeding, Virtual Reality, and Stress Ball on Pain, Anxiety, Cortisol Levels, and Comfort During Episiotomy Repair
Turkey (Türkiye)120 participantsStarted 2026-04
Plain-language summary
The goal of this clinical trial is to learn about the effects of three different interventions-breastfeeding, using a stress ball, or wearing virtual reality (VR) goggles-on pain, anxiety, and stress during episiotomy repair (stitching) after childbirth. It also aims to examine how these methods affect a mother's comfort after the procedure.
The main questions it aims to answer are:
Does breastfeeding, using a stress ball, or using VR goggles lower the mother's pain and anxiety during the repair? Do these interventions reduce the mother's biological stress levels, measured by saliva cortisol tests? Do these methods lead to higher postpartum comfort levels for the mother in the first 24 hours after birth?
Researcher will compare these three intervention groups to a "control group" (mothers receiving standard hospital care) to see which approach is most effective.
Participants will:
Be randomly assigned to one of four groups: Breastfeeding, VR Goggles, Stress Ball, or Standard Care.
Use their assigned intervention throughout the entire episiotomy repair process.
Provide saliva samples before and after the procedure to measure stress hormones (cortisol).
Rate their pain and anxiety levels using clinical scales twice: once before the procedure begins and once immediately after it is finished.
Complete a survey about their comfort levels between 6 and 24 hours after the delivery.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pregnant women between 18 and 45 years of age.
* Primiparous women (first-time mothers).
* Gestational age between 37 and 42 weeks (term pregnancy).
* Singleton pregnancy with a vertex presentation.
* Spontaneous vaginal delivery requiring a mediolateral episiotomy.
* Newborn birth weight between 2500 and 4500 grams.
* Newborn Apgar scores of 7 or higher at the 1st and 5th minutes.
* Ability to read, understand, and speak Turkish fluently.
* Voluntary participation with signed informed consent.
Exclusion and Withdrawal Criteria:
* Requesting to withdraw from the research at any stage.
* Presence of any congenital anomalies in the newborn.
* Presence of maternal visual or hearing impairments.
* Occurrence of fetal mortality or morbidity.
* Occurrence of anal sphincter injury or 3rd/4th-degree lacerations in addition to the episiotomy.
* Performance of the episiotomy repair in an operating room.
* Use of assisted delivery methods (e.g., vacuum extraction).
* Administration of sedative drugs or extra anesthetic agents (excluding routine local perineal infiltration).
* Development of maternal complications (e.g., postpartum hemorrhage) preventing data collection.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Visual Analog Scale for Pain (VAS-P)
Timeframe: Measured twice: baseline (immediately before episiotomy repair) and post-intervention (immediately after episiotomy repair).
2
State-Trait Anxiety Inventory - State (STAI-S)
Timeframe: Measured twice: baseline (immediately before episiotomy repair) and post-intervention (immediately after episiotomy repair).