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临床试验/NCT05955716
NCT05955716已完成不适用

The Effect of Relaxation Exercise Applied With Virtual Reality Glasses on Episiotomy-induced Perineal Pain Score and Fear: A Single-Blind Randomized Controlled Study

Özlem Çiçek2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2022年4月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
76
试验地点
2
主要终点
Score of pain experienced during episiotomy incision

研究概览

简要总结

The aim of this clinical study is to compare the pain and fear scores of women who gave birth for the first time and who did and did not do relaxation exercises with virtual reality glasses during episiotomy incision and episiotomy repair.

This research seeks answers to the following questions:

Question 1: Does doing relaxation exercise with virtual reality glasses reduce the pain score experienced during episiotomy incision? Question 2: Does relaxation exercise with virtual reality glasses reduce the pain score experienced during episiotomy repair? Question 3: Does doing relaxation exercise with virtual reality glasses reduce the fear score experienced during episiotomy incision? Question 4: Does doing relaxation exercise with virtual reality glasses reduce the fear score experienced during episiotomy repair? A group of participants will be given a relaxation exercise with virtual reality glasses during the episiotomy incision and episiotomy repair. Women in the comparison group will not undergo any intervention during episiotomy incision and repair.

详细描述

This research is a single-blind, randomized controlled experimental study with pre-post and control groups. The population of the study consisted of pregnant women who applied to the Delivery Room in İzmir Bakırçay University Çiğli Training and Research Hospital Travay Birth Postpartum Service. The data pool could not be created because the sample was composed of women who applied for childbirth. In this randomized controlled trial, block randomization was applied. Because when simple randomization is applied, there may be a large difference between the numbers of subjects in the two groups when the study is completed. As the difference between the number of pregnant women in the virtual reality glasses and control groups grows, the reliability of the statistical analysis will decrease. Simple randomization is not recommended in cases where the sample size is less than 200. Although it was planned to take 38 experimental and 38 control group samples that met the inclusion criteria, the block randomization was carried out on 100 people, taking into account the exclusion criteria from the sample.

The randomization of the sample was made using the "random number generation program (Research Randomizer)". Intervention and control groups were formed by performing the randomization process by an impartial researcher who was not involved in the research. While it was known by the researchers in which group the pregnant women were, unilateral blindness was provided by not informing the pregnant women about the groups they were in. Since it is recommended in the literature that each step of randomized controlled trials should be performed according to the Consolidated Standards of Reporting Trials (CONSORT), this study was also conducted according to CONSORT. The type 1 error level of the study was determined as 5% (p=o.o5), the type II error level was 0.20 (80% power) and the effect size was 0.3 (moderate). Data were collected between December 2022 and May 2023. Data collection takes an average of 15 minutes.

Virtual Reality Glasses Group:

Pregnant women in the virtual reality glasses group who agreed to participate in the study and watch a relaxation video with virtual reality glasses were expected to answer the questions in the socio-demographic and obstetric information form during the latent phase of labor. Afterwards, they were asked about how many points of pain and fear they would experience on the VAS during the episiotomy incision and repair, on a scale of 0-10. After this form was answered, a relaxation video was watched with virtual reality glasses during the episiotomy incision and repair. After these procedures, as soon as the episiotomy incision and episiotomy repair were completed, virtual reality glasses were removed and the score of pain and fear they experienced was asked. They were asked to rate the pain and fear they experienced, giving a score between 0-10.

Control Group:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • for the study:
  • Turkish literacy
  • Being 18 years or older
  • First vaginal delivery
  • Unattended vaginal delivery
  • Not having a chronic disease
  • Not having any complications during pregnancy
  • Not using anesthetic drugs during labor
  • Agreeing to practice relaxation with virtual reality glasses during the episiotomy incision and suture

排除标准

  • from the study:
  • Inability to read and write Turkish
  • Incomplete answers to survey and scale questions
  • Anesthesia at any stage of birth
  • Deciding to have a cesarean delivery from vaginal delivery
  • Opting out of participating in the research at any time of the research

结局指标

主要结局

Score of pain experienced during episiotomy incision

时间窗: Immediately after episiotomy incision

She evaluated the pain experienced during the episiotomy incision with the help of a visual analog scale. A minimum of 0 and a maximum of 10 points are taken from this scale, and an increase in the scores indicates an increase in the level of pain.

Score of pain experienced during episiotomy repair

时间窗: Immediately after episiotomy repair

She evaluated the pain experienced during the episiotomy repair with the help of visual analog scale. A minimum score of 0 and a maximum score of 10 are taken from this scale, and an increase in scores indicates an increase in the level of pain.

Score of fear experienced during episiotomy incision

时间窗: Immediately after episiotomy incision

She evaluated the fear experienced during the episiotomy incision with the help of visual analog scale. A minimum of 0 and a maximum of 10 points are taken from this scale, and an increase in score indicates an increase in the level of fear.

Score of fear experienced during episiotomy repair

时间窗: Immediately after episiotomy repair

She evaluated the fear experienced during the episiotomy repair with the help of visual analog scale. A minimum of 0 and a maximum of 10 points are taken from this scale, and an increase in score indicates an increase in the level of fear.

次要结局

  • Estimated score of fear experienced during episiotomy incision(Latent phase of birth)
  • Estimated score of pain experienced during episiotomy repair(Latent phase of birth)
  • Estimated score of fear experienced during episiotomy repair(Latent phase of birth)
  • Estimated score of pain experienced during episiotomy incision(Latent phase of birth)

研究者

发起方
Özlem Çiçek
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Özlem Çiçek

Health Science Faculty Department of Nursing

Izmir Bakircay University

研究点 (2)

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