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临床试验/NCT07260838
NCT07260838已完成不适用

The Effect of Showing Fetal Images to High-Risk Pregnant Women on Pregnancy Stress and Sleep Quality

Melike Nur SÖNMEZ1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年12月2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
70
试验地点
1
主要终点
The effect of showing fetal images to high-risk pregnant women on pregnancy stress

研究概览

简要总结

The study will be conducted to determine the effect of showing fetal images to high-risk pregnant women on pregnancy stress and sleep quality.

The study was conducted at Adana City Training and Research Hospital between November 2024 and May 2025 using a randomized controlled, interventional design. The sample of the study consisted of 35 intervention and 35 control group participants, totaling 70 individuals. Data were collected using the Personal Information Form, the Pregnancy Stress Rating Scale (PSRS-36) and the Richard-Campbell Sleep Scale. The intervention group was shown fetal images three times a day for two days; the control group received no intervention. The collected data were analyzed by comparing the pre-test and post-test scores. The data obtained from the study will be evaluated using SPSS IBM 24.0 package program in computer environment.

Research Hypotheses:

In the intervention and control groups; H0-1: Showing fetal images to high-risk pregnant women has no effect on pregnancy stress.

H0-2: Showing fetal images to high-risk pregnant women has no effect on sleep quality.

H1-1: Showing fetal images to high-risk pregnant women has an effect on pregnancy stress.

H1-2: Showing fetal images to high-risk pregnant women has an effect on sleep quality.

详细描述

This study was supported by the Scientific Research Projects Coordination Unit (BAP) of Çukurova University, Project Code: [TYL-2025-17328].

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 45 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Being between the ages of 18 and 45
  • •Having an educational background of elementary school or higher
  • •Being at least 20 weeks pregnant
  • •Having a planned hospital stay of at least 3 days
  • •Being hospitalized for the first time during pregnancy
  • •Being able to speak Turkish
  • •Being able to communicate verbally

排除标准

  • •Having previously participated in the practice of viewing fetal images
  • •Diagnosis of mental illness
  • •Becoming pregnant through infertility treatment
  • •Presence of visual/hearing impairment

研究组 & 干预措施

Intervention Group (Fetal images were shown.)

Experimental

The video containing fetal images will be shown to participants in the intervention group. Support will be obtained from the clinical doctor in preparing this video. At the clinic, each pregnant woman will have a video of her own fetus recorded using an ultrasound device in the examination room, and each pregnant woman will watch the video containing her own fetal images.

干预措施: Showing fetal images (Other)

Control Group

No Intervention

The researcher will not intervene with the pregnant women in the control group.

结局指标

主要结局

The effect of showing fetal images to high-risk pregnant women on pregnancy stress

时间窗: Three times a day for two days

Pregnancy Stress Rating Scale; The scale is a 5-Likert type. The degree of anxiety, distress, and worry experienced by pregnant women is rated as "definitely no," "mild," "moderate," "severe," or "very severe," and scores range from 0 to 4. Perceived stress levels during pregnancy range from a minimum of 0 to a maximum of 144 points. Higher scores on the scale indicate increased stress.

The effect of showing fetal images to high-risk pregnant women on sleep quality

时间窗: Three times a day for two days

Richard-Campbell Sleep Scale; The scale consists of 6 items. Each item is rated on a visual analog scale ranging from 0 to 100. A score between "0-25" on the scale indicates very poor sleep, while a score between "76-100" indicates very good sleep. The total scale score is evaluated based on 5 items; the 6th item, which assesses the noise level in the environment, is excluded from the total score evaluation. As the scale score increases, patients' sleep quality improves.

次要结局

未报告次要终点

研究者

发起方
Melike Nur SÖNMEZ
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Melike Nur SÖNMEZ

Master's Student Researcher

Cukurova University

研究点 (1)

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