NCT07660393

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress24%
Jun 2026Jan 2027

First Submitted

Initial submission to the registry

June 16, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

7 months

First QC Date

June 16, 2026

Last Update Submit

July 16, 2026

Conditions

Fetal Health AnxietyPrenatal DistressPrenatal Attachment

Keywords

Virtual Reality Glasses (VRG)Fetal Health AnxietyPrenatal Distress ScalePrenatal Attachment

Outcome Measures

Primary Outcomes (4)

  • Comparison of sociodemographic characteristics of pregnant women with premature rupture of membranes prior to intervention using questionnaires.

    Sociodemographic information of pregnant women will be collected, compared, and reported through questionnaires.

    6 months

  • Comparison of mean scores on the Fetal Health Concern Scale among groups of pregnant women.

    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

  • Comparison of mean Prenatal Distress Scale scores among groups of pregnant women.

    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

  • Comparison of mean Prenatal Attachment Inventory scores among groups of pregnant women.

    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

Study Arms (2)

Standard prenatal care

PLACEBO COMPARATOR

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.

Other: Standard prenatal careOther: Nature-themed video

Nature-themed video

EXPERIMENTAL

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.

Other: Nature-themed video

Interventions

Standard prenatal careOTHER

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.

Standard prenatal care
Nature-themed videoOTHER

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.

Nature-themed videoStandard prenatal care

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seyhan Çankaya

Konya, 42250, Turkey (Türkiye)

RECRUITING

Study Officials

  • Seyhan Çankaya, Phd

    Selcuk University

    STUDY CHAIR

Central Study Contacts

Seyhan Çankaya

CONTACT

05054300733seyhane32@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Seyhan Çankaya

Study Record Dates

First Submitted

June 16, 2026

First Posted

June 22, 2026

Study Start

June 16, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

July 20, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)