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临床试验/NCT07499011
NCT07499011
已完成
不适用

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

University of Baghdad1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2025年12月16日最近更新:

概览

阶段
不适用
状态
已完成
入组人数
112
试验地点
1
主要终点
Pain intensity measured using the Visual Analog Scale

概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Virtual Reality Group

Experimental

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

干预措施: virtual reality (Device)

Stress Ball Group

Experimental

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

干预措施: stress ball (Other)

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.

干预措施: Virtual Reality Plus Stress Ball (Other)

control group

No Intervention

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

结局指标

主要结局

Pain intensity measured using the Visual Analog Scale

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zahra Abdulameer Fadhala

Principal Investigator

University of Baghdad

研究点 (1)

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