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临床试验/NCT05850624
NCT05850624已完成不适用

Effect of Virtual Reality Animation and Ice Massage on The Hoku Point on Labor Pain, Duration of Labor, and Satisfaction

Kastamonu University1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2022年6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
94
试验地点
1
主要终点
labor pain

研究概览

简要总结

The goal of this study was to compare the effects of ice massage and virtual reality animation on labor pain, duration, and satisfaction with delivery.

The main questions aims to answer are:

H1 There are differences between Ice massage group and/or virtual reality animation groups and the control group in women's' labor pain.

H2 There are differences between Ice massage group and/or virtual reality animation groups and the control group in women's' labor duration.

H3 There are differences between Ice massage group and/or virtual reality animation groups and the control group in women's' satisfaction.

This randomized controlled trial (n = 94) includes three arms. Two intervention groups (ice massage (IMG); virtual reality animation (VRA)) and one control group, (CG). Personal information form, and Visual Analog Scale (VAS) and Birth Satisfaction Scale will used to collect data. Frequency and percentage calculations, Mann Whitney U, Kruskal Wallis test, chi-square test, Tukey's honestly significant difference test, and will used for data analysis.

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 35 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Term primiparous and singleton pregnancies,
  • •Longitudinal and vertex position of the fetus,
  • •Body Mass Index (BMI) below 30,
  • •cervical dilatation of 0-3 cm,
  • •who agreed to participate in the study

排除标准

  • •applying pharmacological intervention during labor,
  • •having a risky pregnancy,
  • •want to withdraw from the study,
  • •having ice allergy,
  • •being visually impaired.

研究组 & 干预措施

ice massage

Experimental

ice massage to hoku point for labor pain for 20 minutes

干预措施: ice massage (Other)

virtual animation

Experimental

watching virtual animation for 20 minutes for labor pain

干预措施: virtual reality animation (Other)

Control Group

No Intervention

receiving standart care

结局指标

主要结局

labor pain

时间窗: active phase up to 20 hours

Visual Analogue Scale (VAS) II

labor duration

时间窗: hour of total delivery (can change 14-18 hours)

Personal Information Form

birth satisfaction

时间窗: postpartum period up to 24 hours

Birth Satisfaction Scale - Revised (BSS-R)

labor pain

时间窗: "Change from Baseline cervical dilatation 0-3 cm (duration can change 8-9 hours)

Visual Analogue Scale (VAS)I

labor duration

时间窗: "Change from Baseline cervical dilatation 6-8 cm(duration can change 4-8 hours)

Personal Information Form

labor duration

时间窗: hour of latent phase ( duration can change 8-9 hour)

Personal Information Form

labor duration

时间窗: hour of placental expulsion (duration can change 10 minutes to 30 minutes)

Personal Information Form

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

Şahika ŞİMŞEK ÇETİNKAYA

Head of Midwifery

Kastamonu University

研究点 (1)

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