Effects of Breastfeeding, Virtual Reality, and Stress Ball on Pain, Anxiety, Cortisol Levels, and Comfort During Episiotomy Repair

Starting soon · Not applicable

Conditions studied: Episiotomy, Breastfeeding, Virtual Reality, Virtual Goggles, Anxiety, Cortisol, Postpartum Comfort, Postpartum Comfort Scale, Stress Physiological, PAIN, ANXIETY, AND COMFORT, Acute Pain, Stress Ball, Midwifery

In brief

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.

Key facts

Study ID

NCT07510477

Run by

Aydin Adnan Menderes University

People needed

120

Starts

2026-04-01

Expected to finish

2027-09-01

Last updated by the study team

2026-04-03

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

Where it is running

• Nazilli State Hospital — Aydin, Nazilli, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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