- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07724249
The Effect of a Virtual Reality Video Intervention
The Effect of a Virtual Reality Headset-Based Video Intervention on Fear of Childbirth and Anxiety in High-Risk Pregnant Women
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pregnancy is a physiological process; however, approximately one-third of pregnancies are classified as high-risk due to maternal, fetal, or obstetric conditions that may threaten the health of the mother and/or fetus. Women with high-risk pregnancies frequently require hospitalization and bed rest for close maternal and fetal monitoring. Although hospitalization is essential for preventing adverse pregnancy outcomes, prolonged bed rest and uncertainty regarding pregnancy outcomes may increase psychological distress, particularly fear of childbirth and anxiety.
Fear of childbirth and anxiety are common among women with high-risk pregnancies and may negatively affect maternal well-being, treatment adherence, and pregnancy outcomes. Therefore, effective, safe, and non-pharmacological interventions that reduce psychological distress during hospitalization are needed.
Virtual reality (VR) is an immersive technology that provides users with a three-dimensional virtual environment and has been increasingly used as a distraction and relaxation intervention in healthcare settings. Previous studies have demonstrated that VR may reduce pain, anxiety, and stress in various clinical populations by diverting attention from unpleasant stimuli and promoting relaxation. However, evidence regarding the effectiveness of VR in reducing fear of childbirth and anxiety among hospitalized women with high-risk pregnancies is limited.
The present study is designed as a randomized controlled trial to evaluate the effectiveness of a VR-based relaxation intervention in hospitalized high-risk pregnant women receiving bed rest. Eligible participants who provide written informed consent will be randomly assigned to either the intervention group or the control group using block randomization.
Participants in the intervention group will receive routine obstetric and nursing care in addition to a VR intervention. During the intervention, participants will wear a compatible VR headset and watch a 360-degree nature-themed relaxation video accompanied by calming natural sounds for approximately 15 minutes while resting in bed. Participants in the control group will receive routine obstetric and nursing care only.
The primary outcomes of the study are fear of childbirth and anxiety. These outcomes will be measured using validated assessment instruments before and after the intervention. The effectiveness of the VR intervention will be determined by comparing outcome measures between the intervention and control groups.
This study is expected to provide evidence regarding the effectiveness of virtual reality as a safe, inexpensive, and non-pharmacological nursing intervention for reducing fear of childbirth and anxiety among hospitalized high-risk pregnant women. If effective, VR may be incorporated into routine prenatal inpatient care to improve maternal psychological well-being.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sümeyye Bal, Ph.D.
- Phone Number: 6424 0(362)3121919
- Email: sumeyyebal@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women aged 18 years or older
- Willing to participate in the study and provide written informed consent
- No diagnosed psychiatric or mental disorder
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual Reality Group
In addition to routine obstetric and nursing care, participants assigned to the virtual reality group will receive a virtual reality intervention.
Women in this group will wear a virtual reality headset while resting in bed and watch a relaxing 360° nature video accompanied by calming natural sounds for approximately 30 minutes.
The virtual reality intervention is designed to promote relaxation and reduce fear of childbirth and anxiety during hospitalization.
|
Participants assigned to the control group will receive routine obstetric and nursing care only.
No additional intervention will be administered.
Other Names:
|
|
No Intervention: control group
Participants assigned to the control group will receive routine obstetric and nursing care only.
No additional intervention will be administered.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State Anxiety
Time Frame: Baseline (immediately before the intervention) and immediately after the 15-minute intervention
|
State Anxiety Inventory (SAI) (State subscale of the State-Trait Anxiety Inventory, STAI-State)
|
Baseline (immediately before the intervention) and immediately after the 15-minute intervention
|
|
Fear of Childbirth
Time Frame: Baseline (immediately before the intervention) and immediately after the 15-minute intervention
|
Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ Version A)
|
Baseline (immediately before the intervention) and immediately after the 15-minute intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/44
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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