Pregnancy, High-RiskNCT07260838
The Effect of Showing Fetal Images to High-Risk Pregnant Women on Stress and Sleep
A study testing Showing fetal images in people with Pregnancy, High-Risk, run by Melike Nur SÖNMEZ at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy, High-Risk
- What is being tested?
- Showing fetal images
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Dec 2024to 19 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Having previously participated in the practice of viewing fetal images
- Diagnosis of mental illness
- Becoming pregnant through infertility treatment
- Presence of visual/hearing impairment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adana City Training and Research Hospital
Adana
About this study
Official title: 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.
Read more
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.
Read the detailed description
This study was supported by the Scientific Research Projects Coordination Unit (BAP) of Çukurova University, Project Code: [TYL-2025-17328].
- Conditions
- Pregnancy, High-Risk
- Being tested
- Showing fetal images
- Keywords
- Risky Pregnancy, Fetal Imaging, Pregnancy Stress, Sleep Quality, Nursing
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Showing fetal imagesOther
High-risk pregnant women in the intervention group were shown fetal images three times a day for two days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Showing fetal images |
| Control Group | No intervention | The researcher will not intervene with the pregnant women in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Three times a day for two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start2 Dec 2024
- Primary completion17 May 2025
- Study completion19 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy, High-RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melike Nur SÖNMEZ
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Melike Nur SÖNMEZ, Cukurova University
- Investigators
- EVŞEN NAZİK, Professor, Study director, Çukurova University Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260838
- Sponsor's protocol ID
- 147-67/06.09.2024
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect participant confidentiality and ensure ethical compliance, individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Showing Fetal Images to High-Risk Pregnant Women on Pregnancy Stress and Sleep Quality
- ClinicalTrials.gov ID
- NCT07260838
- Acronym / sponsor ID
- 147-67/06.09.2024
- Conditions
- Pregnancy, High-Risk
- Keywords
- Risky Pregnancy, Fetal Imaging, Pregnancy Stress, Sleep Quality, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Melike Nur SÖNMEZUniversity, hospital or other
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 17 May 2025 (actual)
- Study completion
- 19 May 2025 (actual)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study was supported by the Scientific Research Projects Coordination Unit (BAP) of Çukurova University, Project Code: [TYL-2025-17328].
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Fetal images were shown.) | Experimental | Other: Showing fetal imagesThe 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. |
| Control Group | No intervention | –The researcher will not intervene with the pregnant women in the control group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- Having previously participated in the practice of viewing fetal images
- Diagnosis of mental illness
- Becoming pregnant through infertility treatment
- Presence of visual/hearing impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Showing fetal imagesHigh-risk pregnant women in the intervention group were shown fetal images three times a day for two days. | Other | Intervention Group (Fetal images were shown.) |
Primary outcome
The effect of showing fetal images to high-risk pregnant women on pregnancy stress
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: No. To protect participant confidentiality and ensure ethical compliance, individual participant data will not be shared.
Related trials for Pregnancy, High-Risk
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
Recruiting
Unravelling Tumour Biology In Ovarian Cancer With Precision Imaging
High Grade Serous Ovarian Cancer
RecruitingPhase 2
Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer
Ovarian Cancer
RecruitingPhase 3
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EVŞEN NAZİK, Professor study director
Çukurova University Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Showing fetal images in people with Pregnancy, High-Risk, run by Melike Nur SÖNMEZ at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of showing fetal images to high-risk pregnant women on pregnancy stress (time frame: Three times a day for two days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.