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临床试验/NCT06896955
NCT06896955尚未招募不适用

Effects of Virtual Reality Application and Progressive Relaxation Exercise Training on Pregnant Women's Stress, Birth Affect and Birth Self-Efficacy

Cukurova University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年3月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
75
试验地点
1
主要终点
Pregnancy Stress Assessment Scale

研究概览

简要总结

In the study, random assignment and randomization concealment will be applied to control selection bias. Pregnant women were assigned to groups by an independent statistician using the block randomization method. For this purpose, 6-digit combinations consisting of the letters "A", "B" and "C" were first created in the randomization of 78 women.

详细描述

There will be three groups in the randomized experimental controlled study:PRE (Progressive Relaxation Exercise), VR (Virtual Reality)+PGR (Progressive Relaxation Exercise) and Control group. In order to carry out the application phase of the study, the responsible researcher participated in the training program on PRE and received a certificate on this subject. In addition, permission for the use of PRE Cd was obtained from the Turkish Psychologists Association to be used in the PRE group. The following procedures will be performed for pregnant women included 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
Single (Participant)

入排标准

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

入选标准

  • •Voluntary participation
  • •No communication difficulties (no mental retardation, no visual/hearing impairment)
  • •Knowing Turkish and being literate
  • •No fetal anomalies
  • •Being in the 32nd week of pregnancy
  • •Not being diagnosed with a risky pregnancy (multiple pregnancy, premature rupture of membranes, preeclampsia, gestational diabetes, placenta previa, etc., pregnancies may end with a cesarean section)

排除标准

  • •Having a psychiatric disease diagnosis

研究组 & 干预措施

PMR Group

Experimental
  • After meeting the pregnant woman in the polyclinic, a personal information form and the Pregnancy Stress Assessment Scale will be filled out at the beginning of the research.
  • PMR will be explained to the pregnant woman and the first application will be done together. Any questions the pregnant woman may have will be answered.
  • An education booklet will be given about PMR.
  • The application will be performed 3 times a week starting at the 32nd week of pregnancy until labor begins, each application lasting 20 minutes.
  • The first application will be done face to face, and subsequent applications will be done by the pregnant woman herself, accompanied by a PMRvideo.
  • Continuous communication will be maintained with the pregnant woman via mobile phone.
  • The Pregnancy Stress Assessment Scale will be filled out at the 38th week.
  • The Birth Affect Scale and Birth Self-Efficacy Scale will be filled out on the first day after birth.

干预措施: PMR Education (Other)

VR+PMR Group

Experimental
  • PMR will be applied to this group accompanied by a therapeutic video shown with virtual reality glasses.
  • At the beginning of the research, a personal information form and the Pregnancy Stress Assessment Scale will be filled out.
  • An educational booklet about PMR will be given.
  • After both application methods are shown and applied, PGE will be applied together accompanied by a therapeutic video shown with virtual reality glasses.
  • The application will be performed 3 times a week starting from the 32nd week of pregnancy until labor begins, 20 minutes each time.
  • The first application will be done face to face, and subsequent applications will be done by the pregnant woman herself.
  • Pregnancy Stress Assessment Scale will be filled out again in the 38th week.
  • On the first day after delivery, the Birth Affect Scale, Birth Self-Efficacy Scale and Virtual Reality Glasses Application Evaluation Form will be filled out.

干预措施: PMR+VR Education (Other)

Control Group

No Intervention
  • Pregnant women in the control group will not be subjected to any treatment other than routine pregnancy follow-up and examinations at the hospital.
  • Forms will be filled out in parallel with the intervention groups.
  • Participants who wish will be given an educational booklet about PGE at the end of the study.

结局指标

主要结局

Pregnancy Stress Assessment Scale

时间窗: pre-intervention, after 2 month

Change in pregnancy-related stress levels in pregnant women. As the score from the scale increases, stress increases.

Birth Self-Efficacy Scale

时间窗: intervention after 2 month

Change in self-efficacy levels of pregnant women during labor. As the score from the scale increases, self-efficacy increases.

Birth Affect Scale

时间窗: intervention after 2 month

Change in the emotional state experienced by mothers during labor. As the score from the scale increases, positive affect increases.

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

Sule Gokyildiz Surucu

Sule Gokyildiz Surucu

Cukurova University

研究点 (1)

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