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

NCT07510477 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-04-03

No results posted yet for this study

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.

Conditions

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

Interventions

PROCEDURE

Breastfeeding and Skin-to-Skin Contact

Midwife-supported breastfeeding and skin-to-skin contact initiated before episiotomy repair and maintained throughout the procedure.

DEVICE

Virtual Reality (VR) Goggles

Use of VR goggles to provide relaxing visual and auditory nature content as a sensory distraction during episiotomy repair.

BEHAVIORAL

Rhythmic Stress Ball Application

A physical distraction technique where participants rhythmically squeeze and release a ball while counting from 1 to 3 throughout the procedure.

Sponsors & Collaborators

  • Aydın Aynan Menderes University Scientific Research Projects Coordination Unit

    collaborator UNKNOWN
  • Aydin Adnan Menderes University

    lead OTHER

Principal Investigators

  • Ayden ÇOBAN, PhD, Prof. · AydiAdnan Menderes University, Faculty of Health Sciences, Department of Midwifery

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-09-30
Completion
2027-09-30

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07510477 on ClinicalTrials.gov