NCT07260838

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 2, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 3, 2025

Completed
Last Updated

December 3, 2025

Status Verified

November 1, 2025

Enrollment Period

6 months

First QC Date

November 16, 2025

Last Update Submit

December 2, 2025

Conditions

Keywords

Risky PregnancyFetal ImagingPregnancy StressSleep QualityNursing

Outcome Measures

Primary Outcomes (2)

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

    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.

    Three times a day for two days

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

    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.

    Three times a day for two days

Study Arms (2)

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.

Other: Showing fetal images

Control Group

NO INTERVENTION

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

Interventions

High-risk pregnant women in the intervention group were shown fetal images three times a day for two days.

Intervention Group (Fetal images were shown.)

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study only covers women with high-risk pregnancies.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adana City Training and Research Hospital

Adana, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • EVŞEN NAZİK, Professor

    Çukurova University Faculty of Health Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Master's Student Researcher

Study Record Dates

First Submitted

November 16, 2025

First Posted

December 3, 2025

Study Start

December 2, 2024

Primary Completion

May 17, 2025

Study Completion

May 19, 2025

Last Updated

December 3, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

To protect participant confidentiality and ensure ethical compliance, individual participant data will not be shared.

Locations