NCT07724249

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Jul 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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 Progress28%
Jul 2026Sep 2026

First Submitted

Initial submission to the registry

July 8, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

July 15, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 24, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2026

Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 8, 2026

Last Update Submit

July 23, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • State Anxiety

    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

    Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ Version A)

    Baseline (immediately before the intervention) and immediately after the 15-minute intervention

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

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.

Other: Virtual Reality Group

control group

NO INTERVENTION

Participants assigned to the control group will receive routine obstetric and nursing care only. No additional intervention will be administered.

Interventions

Participants assigned to the control group will receive routine obstetric and nursing care only. No additional intervention will be administered.

Also known as: control
Virtual Reality Group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged 18 years or older
  • Willing to participate in the study and provide written informed consent
  • No diagnosed psychiatric or mental disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Sümeyye Bal, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

July 8, 2026

First Posted

July 24, 2026

Study Start

July 15, 2026

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

September 15, 2026

Last Updated

July 24, 2026

Record last verified: 2026-07