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临床试验/NCT06853821
NCT06853821已完成不适用

The Effect of Comfort Theory-Based Care and the Use of Virtual Reality Glasses on Pain and Comfort in the Postpartum Period: Randomized Controlled Study

Sakarya University1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2025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
发起方
入组人数
105
试验地点
1
主要终点
Postpartum Comfort Scale

研究概览

简要总结

The research will be conducted to determine the effect of comfort theory-based care and virtual reality glasses on pain and comfort levels in women who have given birth to primiparous babies. The hypotheses of the study are:

H0: Comfort theory-based care and the use of virtual reality glasses have no effect on pain and comfort in the postpartum period.

H1-1: Comfort theory-based care has an effect on pain level in the postpartum period.

H1-2: Comfort theory-based care has an effect on comfort in the postpartum period.

H2-1: The use of virtual reality glasses in the postpartum period has an effect on the level of pain.

H2-2: The use of virtual reality glasses in the postpartum period has an effect on comfort.

详细描述

Although pregnancy and birth are normal processes, the type of birth affects the comfort level, quality of life, and pain in the natal and postnatal period. In our country, as in many other countries, cesarean delivery rates are quite high.Pain in cesarean births is more severe and lasts longer than in vaginal birth. Along with many methods to reduce pain, the effectiveness of virtual reality applications is also emphasized theoretically or conceptually.In the planned randomized controlled study, the pain level and comfort of individuals will be measured by applying virtual reality glasses to one of the experimental groups and giving Kolcaba's Comfort Theory-based care to the other. Personal Information Form, Postpartum Comfort Scale, Visual Analogue Scale (VAS) and Virtual Reality Glasses Form will be used as measurement tools.This study aims to reduce the pain of the mother in the short term and enable the mother to participate in self-care and baby care in a shorter period of time, and in the long term to minimize maternal and newborn deaths and eliminate deaths under the age of 5.Increasing maternal comfort during the postpartum period is expected to have a direct impact on maintaining maternal health and indirectly on baby care.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Participants were assigned to groups using the "simple randomization" method. Participants were not informed about which group they were in.

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

  • •Volunteering to participate in research
  • •Having given birth with epidural anesthesia
  • •Being between the ages of 18-35
  • •Having given birth within 37-41 weeks of pregnancy
  • •Having a primiparous cesarean birth

排除标准

  • •Having a normal birth
  • •Having given birth with general anesthesia
  • •Having a disability that limits vision, hearing or communication
  • •Having a systemic disease, hypertension, preeclampsia or uterine atony and risk of bleeding

研究组 & 干预措施

Control Group

No Intervention

No intervention will be given to the control group.

Pre-Post Test:

A personal information form, postpartum comfort scale and visual analog scale will be applied to individuals.

Experimental Group (Comfort Theory Based Care

Experimental

The experimental group will be intervened by providing comfort theory-based care.

Pre-Post Test:

A personal information form, postpartum comfort scale and visual analog scale will be applied to individuals.

干预措施: Comfort Theory Based Care (Other)

Experimental Group (Virtual Reality Glasses)

Experimental

The experimental group will be intervened with virtual reality glasses.

干预措施: Virtual Reality Glasses (Other)

结局指标

主要结局

Postpartum Comfort Scale

时间窗: postpartum first day, postpartum second day, postpartum third day

It is a 5-point Likert type scale consisting of 34 items developed by Katharine Kolcaba (1994). Cronbach's Alpha number of the scale was determined as 0.78. The minimum score from the scale is 34 and the maximum score is 170. As the score increases, comfort increases.

Visual Analog Scale

时间窗: postpartum first day, postpartum second day, postpartum third day

It is used to evaluate pain severity. On the numerical rating scale, pain ranges from 0 (absence of pain) to 10 (unbearable pain) (Huskisson, 1974).

次要结局

未报告次要终点

研究者

发起方
Sakarya University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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