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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07499011
Enrollment
112
Registered
2026-03-27
Start date
2025-12-16
Completion date
2026-02-13
Last updated
2026-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perineal Pain

Keywords

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

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.

Interventions

DEVICEvirtual reality

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

OTHERstress ball

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

OTHERVirtual Reality Plus Stress Ball

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

Sponsors

University of Baghdad
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain intensity measured using the Visual Analog ScalePeriproceduralPain 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

Countries

Iraq

Contacts

STUDY_DIRECTORNuha adel Ibrahim, Dr

University of Baghdad

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026