Comparison of Virtual Reality and Stress Ball for Pain During Episiotomy Repair

NCT07499011 | Completed

• 1 other identifier: VRSB-EPI-RCT-2026-01
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a four-arm randomized controlled trial designed to evaluate the effectiveness of non-pharmacological interventions for pain management during episiotomy repair among women undergoing vaginal birth. Participants will be allocated to one of four groups: virtual reality, stress ball, combined virtual reality plus stress ball, or control. The virtual reality intervention is intended to provide immersive distraction, while the stress ball offers tactile distraction; the combined group receives both interventions simultaneously. The control group receives routine care only. The primary outcome is pain intensity measured during the procedure using the Visual Analog Scale. Outcome data will be compared across groups to identify the most effective intervention for reducing pain during episiotomy repair. This study may provide evidence for practical, safe, and low-cost supportive strategies that can improve maternal comfort during childbirth procedures.

Conditions

Perineal Pain

Keywords

Virtual Reality; stress ball; non-pharmacology; episiotomy repair; perineal repair; Pain Management

Outcome Measures

Primary Outcomes (1)

• Pain intensity measured using the Visual Analog Scale

  Pain intensity during episiotomy repair will be assessed using the Visual Analog Scale 0 to 10 scale, where 0 indicates no pain and 10 indicates the worst pain possible. Higher scores indicate greater pain intensity. Pain scores will be compared cross the virtual reality, stress ball, combined virtual reality plus stress ball, and control groups

  Periprocedural

Study Arms (4)

Virtual Reality Group

EXPERIMENTAL

Participants in this group will receive virtual reality during episiotomy repair in addition to routine care.

Device: virtual reality

Stress Ball Group

EXPERIMENTAL

Participants in this group will use a stress ball during episiotomy repair in addition to routine care.

Other: stress ball

virtual reality and stress ball

EXPERIMENTAL

Participants in this group will receive combined virtual reality and stress ball intervention during episiotomy repair in addition to routine care.

Other: Virtual Reality Plus Stress Ball

control group

NO INTERVENTION

Participants in this group will receive routine care during episiotomy repair without virtual reality or stress ball intervention.

Interventions

virtual reality DEVICE

Use of virtual reality goggles during episiotomy repair as a non-pharmacological pain management intervention.

Virtual Reality Group

stress ball OTHER

Use of a stress ball during episiotomy repair as a non-pharmacological pain management intervention.

Stress Ball Group

Virtual Reality Plus Stress Ball OTHER

Combined use of virtual reality goggles and a stress ball during episiotomy repair as a non-pharmacological pain management intervention.

virtual reality and stress ball

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18 to 42 years
• Able to communicate and understand the study procedures
• No vision, hearing, or perception problems
• No physical problems preventing squeezing a stress ball
• No diabetes mellitus
• Undergoing episiotomy repair after vaginal birth
• Willing to participate and provide informed consent

You may not qualify if:

• Pre-existing chronic pain conditions
• Severe perineal tear (3rd or 4th degree)
• Development of any complication during the procedure
• Women who did not consent to participate in the study
• Women undergoing episiotomy repair with local anesthetic infiltration

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Feminine and Children Teaching Hospital and al _Rumaitha Hospital

Samawah, Muthanna Governorate, Iraq

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nuha adel Ibrahim, Dr

  University of Baghdad

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 27, 2026
• Study Start: December 16, 2025
• Primary Completion: February 13, 2026
• Study Completion: February 13, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)