The Effect of Virtual Reality Glasses on Sleep Quality and Anxiety Level in High-risk Pregnant Women

NCT06996457 | Not Yet Recruiting DMC

• 1 other identifier: Ethics Decision 13/7, 05.09.20
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine the effect of watching nature videos accompanied by natural sounds (music) through virtual reality (VR) headsets on sleep quality, state anxiety, and trait anxiety levels in high-risk pregnant women. The research is designed as a single-blind, randomized controlled experimental study. Data collection tools include the Pregnant Information Form, State-Trait Anxiety Inventory (STAI), and the Pittsburgh Sleep Quality Index (PSQI). The collected data will be analyzed using SPSS 25. Data collection is planned to take place between June 2025 and December 2026.

Conditions

Virtual Reality; Pregnancy; Anxiety; Sleep Quality

Outcome Measures

Primary Outcomes (3)

• Assessment of trait anxiety levels in high-risk pregnant women.

  An assessment will be conducted using the Trait Anxiety Inventory.

  5th day

• Assessment of state anxiety levels in high-risk pregnant women

  An assessment will be conducted using the State Anxiety Inventory.

  5th day

• To determine the sleep quality of high-risk pregnant women.

  An assessment will be conducted using the Pittsburgh Sleep Quality Index.

  5th day

Study Arms (2)

1

EXPERIMENTAL

Virtual Reality Headset Group

Device: VR

2

NO INTERVENTION

No intervention will be performed.

Interventions

VR DEVICE

The use of a virtual reality (VR) headset to present videos with nature imagery and natural sounds (music)

1

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women who are hospitalized due to high-risk pregnancy and have been admitted for more than 3 days,
• Able to communicate verbally,
• Having no hearing or visual impairments,
• Citizens of the Republic of Türkiye,
• Willing to participate in the study.

You may not qualify if:

• Having a diagnosed psychiatric disorder,
• Inability to speak Turkish.

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz Üniversitesi

Antalya, Konyalalt, 07070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Feyzanur GÜLÇELİK, Specialist Nurse

CONTACT

+90 5389788986; feyzanurgulcelik@gmail.com

Nurcan KIRCA, Doç. Dr.

CONTACT

+90 5054168620; nurcankirca@akdeniz.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Student

Model Details: Paralel özelliklere sahip iki Grup vardır. İlk grup sanal gerçeklik gözlükleri kullanan deneysel gruptur. İkinci grup ise herhangi bir müdahalede bulunulmayan kontrol grubudur.

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 30, 2025
• Study Start: June 1, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)