The Effect of a Virtual Reality Video Intervention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual Reality Group.
- Who it may be relevant to
- Registry conditions: High-Risk Pregnancy, Anxiety. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of a Virtual Reality Headset-Based Video Intervention on Fear of Childbirth and Anxiety in High-Risk Pregnant Women
Overview
This randomized controlled trial aims to evaluate the effect of a virtual reality (VR) video intervention on fear of childbirth and anxiety among hospitalized high-risk pregnant women receiving bed rest. High-risk pregnancy and prolonged hospitalization may increase psychological distress, including fear of childbirth and anxiety. Virtual reality has emerged as a non-pharmacological distraction technique that promotes relaxation by immersing individuals in calming virtual environments. Participants in the intervention group will watch a nature-themed VR video with relaxing sounds using a VR headset in addition to routine care, while the control group will receive routine care only. The findings may provide evidence for the use of VR as a supportive nursing intervention to improve the psychological well-being of hospitalized high-risk pregnant women.
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.
Interventions
- Other Virtual Reality Group
Participants assigned to the control group will receive routine obstetric and nursing care only. No additional intervention will be administered.
Primary outcome measures
- State Anxiety [Time frame: 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]
Eligibility criteria
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
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07724249 · 2023/44