NCT07510477

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

Effects of Breastfeeding, Virtual Reality, and Stress Ball on Pain, Anxiety, Cortisol Levels, and Comfort During Episiotomy Repair in Primiparous Women: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Aydin Adnan Menderes University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

Study Rationale and Background: Episiotomy is a common surgical procedure performed during vaginal delivery to facilitate the baby's passage. In Turkey, episiotomy rates among primiparous women are reported to be as high as 89-95%. This procedure often leads to significant maternal pain and anxiety during the repair (stitching) phase. There is an increasing need for person-centered interventions that can be easily integrated into midwifery care to manage pain and stress. Objective: The primary objective of this randomized controlled experimental study is to evaluate the effects of three different interventions-Breastfeeding, Virtual Reality (VR) Goggles, and Stress Ball-on maternal pain, anxiety, saliva cortisol levels, and postpartum comfort during episiotomy repair. Methodology and Interventions: The study will be conducted with primiparous women who are randomly assigned to one of four groups: Intervention Group 1 (Breastfeeding): Mothers will initiate breastfeeding their newborns during the episiotomy repair. Intervention Group 2 (Virtual Reality): Mothers will wear VR goggles and watch relaxing, pre-selected content to provide a cognitive distraction during the procedure. Intervention Group 3 (Stress Ball): Mothers will use a stress ball to redirect their focus and manage physical tension during the repair. Control Group: Mothers will receive standard hospital care and routine midwifery support. Measurements and Data Collection: Data will be collected at multiple time points to assess the physiological and psychological impact of the interventions: Pain Intensity: Measured using the Visual Analog Scale (VAS-P). Assessments will be performed twice: immediately before the start of the repair and immediately after completion. Anxiety Levels: Evaluated using the State-Trait Anxiety Inventory (STAI-S). Scores will be recorded before and after the repair process. Biochemical Stress Response: Saliva cortisol levels will be analyzed to provide an objective measure of the stress response. Samples will be collected pre-intervention and post-intervention. Postpartum Comfort: Assessed using the Postpartum Comfort Scale between the 6th and 24th hour following the delivery. Statistical Analysis Plan: The data will be analyzed to compare the efficacy of the three interventions against the control group. Differences in pain, anxiety, cortisol, and comfort scores will be evaluated to determine which application (if any) significantly affects the maternal experience during the early postpartum period.

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

Type	Name	Description
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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2026-04-03
• Last updated: 2026-04-03

Locations

1 site across 1 country: Turkey (Türkiye)