- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07260838
The Effect of Showing Fetal Images to High-Risk Pregnant Women on Stress and Sleep
The Effect of Showing Fetal Images to High-Risk Pregnant Women on Pregnancy Stress and Sleep Quality
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Adana, Turkey (Türkiye)
- Adana City Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Having previously participated in the practice of viewing fetal images
- Diagnosis of mental illness
- Becoming pregnant through infertility treatment
- Presence of visual/hearing impairment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention Group (Fetal images were shown.)
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.
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High-risk pregnant women in the intervention group were shown fetal images three times a day for two days.
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No Intervention: Control Group
The researcher will not intervene with the pregnant women in the control group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The effect of showing fetal images to high-risk pregnant women on pregnancy stress
Time Frame: Three times a day for two days
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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.
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Three times a day for two days
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The effect of showing fetal images to high-risk pregnant women on sleep quality
Time Frame: Three times a day for two days
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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.
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Three times a day for two days
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: EVŞEN NAZİK, Professor, Çukurova University Faculty of Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 147-67/06.09.2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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