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.

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Key information

Conditions

Perineal Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Feminine and Children Teaching Hospital and al _Rumaitha Hospital

Samawah, Muthanna Governorate, Iraq

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Virtual reality

Device

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

Stress ball

Other

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

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.

Primary outcomes

Pain intensity measured using the Visual Analog Scale

Time frame: Periprocedural

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

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Mar 27, 2026
Registry last updated: Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed