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临床试验/NCT06232057
NCT06232057已完成不适用

The Effect of Preoperative Virtual Reality Glasses Use on Postoperative Pain and Anxiety in Women Having a Caesarean Section

Amasya University2 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2024年2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
入组人数
100
试验地点
2
主要终点
Postoperative pain level-2

研究概览

简要总结

The goal of this randomized controlled trial is to examine the effect of preoperative virtual reality used before cesarean on postoperative pain and anxiety. The main question[s] it aims to answer are:

  • What is the anxiety level of women in the intervention and control groups after using virtual reality?
  • What is the pain level of women in the intervention and control groups after using virtual reality?

Women in the intervention group will be shown a relaxing video accompanied by virtual reality glasses before cesarean. No intervention will be applied to women in the control group. Researchers will compare pre- and post-operative anxiety levels and post-operative pain levels of both groups.

详细描述

Cesarean is a major surgical operation that is widely performed around the world. Pain after cesarean is more significant than expected, and pain control remains a problem. In addition, the women undergoing cesarean experience stress and anxiety due to the surgical process. Anxiety and pain experienced after cesarean affect the mother physiologically and psychologically, negatively affecting the healing process. Therefore, it is essential to determine interventions that will reduce pain and anxiety in women undergoing cesarean. This study aims to examine the effect of preoperative virtual reality use on postoperative pain and anxiety in women undergoing cesarean.

This study has a randomized controlled experimental design. The research will be carried out in the Obstetrics and Gynecology Clinic of a public hospital in the North of Turkey. Women who had a cesarean will be included in the study. Participants will be randomly assigned to the intervention or control group using a computer-generated list. A data collection form including an Introductory information form including sociodemographic and obstetric characteristics, Spielberger State-Trait Anxiety Inventory (STAI), and Visual Analog Scale (VAS) will used for each participant. After obtaining written informed consent, the anxiety levels of women in the intervention and control groups will be determined by applying a pre-test (STAI). Then, the women in the intervention group will be shown a relaxing video (video with a nature view accompanied by nature sounds) through preoperative virtual reality glasses. No intervention will be applied to women in the control group. After surgery, the anxiety levels of women in both groups will be evaluated in the first 4 hours, and the pain levels will be evaluated in the 2nd, 4th, and 6th hours. The IBM SPSS (Statistical Package for the Social Sciences) 21.0 package program will be used to evaluate the data obtained in the study.

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

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 18 years and over
  • Communicate in Turkish
  • Must have cesarean with spinal anesthesia
  • Must have cesarean after the 37th week of pregnancy
  • Must have a planned cesarean

排除标准

  • Under 18 years
  • Not being able to speak Turkish
  • Vision and hearing problem
  • Cesarean section with general anesthesia
  • Emergency cesarean

研究组 & 干预措施

Intervention Group

Experimental

Virtual Reality Application Group

干预措施: Virtual Reality (Other)

Control Group

No Intervention

Control group without any intervention

结局指标

主要结局

Postoperative pain level-2

时间窗: Postoperative 4th hour

The pain level at the 4th hour after cesarean section will be measured with VAS.

Postoperative anxiety level

时间窗: Within the first 4 hours postoperatively

Anxiety level after cesarean section will be measured with STAI within the first 4 hours.

Preoperative anxiety level

时间窗: Preoperatif

Preoperative anxiety level will be measured with STAI.

Postoperative pain level-1

时间窗: Postoperative 2nd hour

The pain level at the 2nd hour after cesarean section will be measured with VAS.

Postoperative pain level-3

时间窗: Postoperative 6th hour

The pain level at the 6th hour after cesarean section will be measured with VAS.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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