Comparison Between Virtual Reality and Stress Ball Intervention In Managing Pain During Episiotomy Repair

Comparison Between Virtual Reality and Stress Ball Intervention in Managing Pain During Episiotomy Repair

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.

Study Overview

• Status: Completed
• Conditions: Perineal Pain
• Intervention / Treatment: Device: virtual reality; Other: stress ball; Other: Virtual Reality Plus Stress Ball

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Muthanna Governorate
    • Samawah, Muthanna Governorate, Iraq
      • Feminine and Children Teaching Hospital and al _Rumaitha Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

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

Exclusion Criteria

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Group; Participants in this group will receive virtual reality during episiotomy repair in addition to routine care.	Device: virtual reality; Use of virtual reality goggles during episiotomy repair as a non-pharmacological pain management intervention.
Experimental: Stress Ball Group; Participants in this group will use a stress ball during episiotomy repair in addition to routine care.	Other: stress ball; Use of a stress ball during episiotomy repair as a non-pharmacological pain management intervention.
Experimental: virtual reality and stress ball; 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; Combined use of virtual reality goggles and a stress ball during episiotomy repair as a non-pharmacological pain management intervention.
No Intervention: control group; Participants in this group will receive routine care during episiotomy repair without virtual reality or stress ball intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Baghdad
• Investigators: Study Director: Nuha adel Ibrahim, Dr, University of Baghdad

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2025
• Primary Completion (Actual): February 13, 2026
• Study Completion (Actual): February 13, 2026

Study Registration Dates

• First Submitted: March 19, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Virtual Reality; Pain Management; stress ball; perineal repair; non-pharmacology; episiotomy repair
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia
• Other Study ID Numbers: VRSB-EPI-RCT-2026-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No