- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07660393
Virtual Reality Glass Use
The Effect of Virtual Reality Glass Use on Fetal Health Anxiety, Prenatal Distress, and Maternal-Fetal Attachment in Women With Premature Rupture of Membranes: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Seyhan Çankaya
- Phone Number: 05054300733
- Email: seyhane32@gmail.com
Study Locations
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-
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Konya, Turkey (Türkiye), 42250
- Recruiting
- Seyhan Çankaya
-
Contact:
- Seyhan Çankaya
- Phone Number: 05054300733
- Email: seyhane32@gmail.com
-
Principal Investigator:
- Seyhan Çankaya, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being 18 years of age or older
- Being nulliparous
- Having a diagnosis of preterm premature rupture of membranes (PPROM)
- Being between 24 and 37 weeks of gestation
- Having a singleton pregnancy
- Being hospitalized in the ward for at least 3 days
- Having no visual or hearing impairment
- Being communicative and mentally and psychologically healthy
- Being able to speak and express oneself in Turkish
Exclusion Criteria:
- Having an additional diagnosis besides preterm premature rupture of membranes (PPROM) (e.g., preeclampsia, fetal distress, fetal anomalies, gestational diabetes, bleeding, etc.)
- Having a chronic disease (e.g., hypertension, diabetes mellitus, thyroid disorders, etc.)
- Having conceived through assisted reproductive technologies (ART)
- Having any skin infection.
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 |
|---|---|
|
Placebo Comparator: Standard prenatal care
The control group will receive standard prenatal care and treatment provided by the hospital. After the study is completed, control group participants will be shown nature-themed videos via Virtual Reality Glasses (VRG) if they wish. |
The control group will receive standard prenatal care and treatment provided by the hospital. After the study is completed, control group participants will be shown nature-themed videos via Virtual Reality Glasses (VRG) if they wish.
Pregnant women with premise rupture of membranes (PRM) in the intervention group will be shown a nature-themed video prepared by the researchers with nature sounds via Virtual Reality Glasses (VRG) twice a day for at least five minutes each time for three days.
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|
Experimental: Nature-themed video
Pregnant women with premise rupture of membranes (PRM) in the intervention group will be shown a nature-themed video prepared by the researchers with nature sounds via Virtual Reality Glasses (VRG) twice a day for at least five minutes each time for three days.
|
Pregnant women with premise rupture of membranes (PRM) in the intervention group will be shown a nature-themed video prepared by the researchers with nature sounds via Virtual Reality Glasses (VRG) twice a day for at least five minutes each time for three days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of sociodemographic characteristics of pregnant women with premature rupture of membranes prior to intervention using questionnaires.
Time Frame: 6 months
|
Sociodemographic information of pregnant women will be collected, compared, and reported through questionnaires.
|
6 months
|
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Comparison of mean scores on the Fetal Health Concern Scale among groups of pregnant women.
Time Frame: 6 months
|
The Fetal Health Concern Scale will be administered to pregnant women. The Fetal Health Concern Scale ranges from 0 to 42 points (minimum-maximum), with higher scores indicating greater fetal health concern. |
6 months
|
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Comparison of mean Prenatal Distress Scale scores among groups of pregnant women.
Time Frame: 6 months
|
The Prenatal Distress Scale will be administered to all pregnant women. The Prenatal Distress Scale ranges from 0 to 34 points (minimum-maximum), with higher scores indicating greater prenatal distress. |
6 months
|
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Comparison of mean Prenatal Attachment Inventory scores among groups of pregnant women.
Time Frame: 6 months
|
The Prenatal Attachment Inventory will be administered to all pregnant women. The Prenatal Attachment Inventory score ranges from 21 to 84 points (minimum-maximum), with higher scores indicating greater prenatal distress. |
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2025/1150
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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