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临床试验/NCT05134376
NCT05134376已完成不适用

The Effect of Virtual Reality Glasses Watched With Music on Pain Perceived by Women During Episiotomy Repair, Vital Signs and Postpartum Comfort

Aydin Adnan Menderes University1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2020年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
84
试验地点
1
主要终点
Numerical Pain Rating Scale

研究概览

简要总结

This research was carried out to evaluate the effect of video and accompanying music played with virtual reality glasses during episiotomy repair on women's perceived pain, vital signs and postpartum comfort during episiotomy repair.

This research is a randomized controlled experimental study. The study was conducted on 84 pregnant women, 40 of whom were in the intervention group and 44 were in the control group.

The goals expected to be achieved during the research are; Reducing the perceived pain during episiotomy repair with video and accompanying music played with virtual reality glasses during episiotomy repair Video and accompanying music watched with virtual reality glasses during episiotomy repair increase postpartum comfort The positive effect of video and accompanying music on vital signs during episiotomy repair with virtual reality glasses

详细描述

Workgroup implementation steps Informed Voluntary Consent Form and Pregnancy Introductory Form (the first 8 questions of the pregnant introductory information - labor and episiotomy follow-up form) will be filled in by the researcher, to the pregnant women who were randomized daily to the study and control group by going to the clinic during the research. During the repair of mediolateral episiotomy, the pregnant women included in the study group will be shown the video accompanying the acemaşîrân makam with sterile virtual reality glasses with a view of nature. In the literature, it is stated that the video watched with the acemaşîrân makam and virtual reality glasses reduces pain [6, 7, 21] After the internet connection is established with a smart phone, the video to be clicked on youtube.com will be clicked, Relaxation Project 1 (SBS VR) video and Acemaşiran Ayini Şerifi Ney-Bendir will be selected for the sound, and video and music will be played with virtual reality glasses by pressing the play button[22, 23] Sound and image will be adjusted as the pregnant woman wants. During the study, all pregnant women included in the study will be given the same care and follow-up, apart from watching the video. The video containing nature scenes prepared by the researcher and the acemaşîrân maqam will be watched from the moment the episiotomy is opened to the time when the episiotomy is closed. Numerical pain assessment scale will be applied before, during (during hymen suturing) and 1 hour after the end of mediolateral episiotomy repair. Postpartum comfort scale 4-24th postpartum. The vital signs of the pregnant women in the study group will be recorded by the researcher before and during episiotomy repair (during hymen suturing) and 1 hour after the end of mediolateral episiotomy repair. In episiotomy repair, the time from the first suture to the last column will be recorded. The pregnant woman will be asked how long she perceives the duration of episiotomy.

Control group application steps Unlike the experimental group, only video and music applications will not be applied to the pregnant women included in the control group. Other applications will be made in the same way.

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
None

盲法说明

episiotomy application and intervention was done by midwives

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •18 - 35 years
  • •primiparous,
  • •gestational week 37- 42
  • •Mediolateral episiotomy performed
  • •pregnant women in active phase

排除标准

  • •high risk pregnancy
  • •vision and hearing problem
  • •with deep laceration
  • •3rd and 4th degree laceration

研究组 & 干预措施

Workgroup

Experimental

During the repair of the mediolateral episiotomy, the pregnant women included in the study group will be shown a video accompanying the acemaşîrân office with sterile virtual reality glasses with a view of nature.

干预措施: During Episiotomy Repair, Women Will Be Watching Virtual Reality Glasses Accompanied by Music (Other)

Control

No Intervention

Unlike the experimental group, only video and music applications will not be applied to the pregnant women included in the control group. Other applications will be done in the same way.

结局指标

主要结局

Numerical Pain Rating Scale

时间窗: one hour after the intervention.

In the numerical evaluation scale, pain ranges from 0 (absence of pain) to 10 (unbearable pain).

Postpartum Comfort Scale

时间窗: after 24 hours

The lowest score to be taken on the scale is 34, and the highest score is 170.

pulse,

时间窗: before the episiotomy intervention, during the hymen suturing during the episiotomy, and one hour after the intervention

minute;

Systolic Blood Pressure

时间窗: one hour after the intervention

mmHg;

espiratory rate

时间窗: one hour after the intervention

unit

diastolic Blood Pressure

时间窗: one hour after the intervention

mmHg;

Numerical Pain Rating Scale

时间窗: before the episiotomy intervention,

In the numerical evaluation scale, pain ranges from 0 (absence of pain) to 10 (unbearable pain).

diastolic Blood Pressure

时间窗: before the episiotomy intervention,

mmHg;

Numerical Pain Rating Scale

时间窗: during the hymen suturing during the episiotomy,

In the numerical evaluation scale, pain ranges from 0 (absence of pain) to 10 (unbearable pain).

Systolic Blood Pressure

时间窗: before the episiotomy intervention,

mmHg;

Systolic Blood Pressure

时间窗: during the hymen suturing during the episiotomy,

mmHg;

diastolic Blood Pressure

时间窗: during the hymen suturing during the episiotomy, n

mmHg;

espiratory rate

时间窗: before the episiotomy intervention,

unit

espiratory rate

时间窗: during the hymen suturing during the episiotomy,

unit

次要结局

未报告次要终点

研究者

发起方
Aydin Adnan Menderes University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mine Gokduman Keles

Head of Otolaryngology

Aydin Adnan Menderes University

研究点 (1)

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