NCT07020975

Brief Summary

This study examines the impact of virtual reality (VR) applications on anxiety levels before and after embryo transfer procedures. The clinical trial will involve 80 participants, aged 18 to 50, who are receiving treatment at a healthcare facility in the Turkish Republic of Northern Cyprus (TRNC). The primary objective is to evaluate the effectiveness of VR as an intervention for reducing anxiety in individuals undergoing assisted reproductive treatments.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 13, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

June 13, 2025

Status Verified

June 1, 2025

Enrollment Period

1 year

First QC Date

June 3, 2025

Last Update Submit

June 12, 2025

Conditions

AnxietyAssisted Reproductive TreatmentsWomenVRStressVirtual GogglesInfertilityEmbryo Transfer

Keywords

AnxietyAssisted Reproductive TreatmentsWomenNurseVRTechnologyInfertilityEmbryo Transfer

Outcome Measures

Primary Outcomes (1)

  • Anxiety level of the women who went through embryo transfer.

    This study aims to assess the anxiety levels of women who undergo a virtual reality (VR) experience before and after embryo transfer. The participants will be divided into two groups: those who receive relaxing Zen music and view natural landscapes through VR glasses, and those who do not. Anxiety levels will be objectively measured using the State-Trait Anxiety Inventory, both before and after the embryo transfer procedure.

    1 year

Study Arms (2)

Intervention Group with VR Glasses

EXPERIMENTAL

Forty women will experience a calming ZEN music soundtrack and view natural landscapes through VR glasses both before and after the embryo transfer procedure.

Device: VR Glasses

Control Group with routine care

NO INTERVENTION

Forty women will receive standard routine care before and after the embryo transfer procedure (Explanation of how to use the medication).

Interventions

VR GlassesDEVICE

VR Glasses is used to help people be in a virtual reality other than their real life. What we use this for; to get away infertile women from her stressfull environment to another virtual reality before their embryo transfer.

Intervention Group with VR Glasses

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSince our participants are women undergoing fertility treatments, only female patients who are scheduled for embryo transfer will be included in the study.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteered to participate in the research,
  • years old
  • No vision and hearing problems,
  • Not disoriented in time and place,
  • Primary infertile
  • Not having communication problem
  • Can read \& write
  • No mental pathological disease

You may not qualify if:

  • Secondary infertility
  • Having experienced bleeding, miscarriage, etc. after embryo transfer,
  • Difficulty communicating,
  • Problems such as migraine, vertigo, dizziness,
  • Patients who wear prescription glasses and have vision problems without glasses
  • Refused to participate in the research
  • Patients with psychiatric pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cyprus Aydin University

Girne Kepuveia, Keryneia, 99000, Cyprus

Location

Related Publications (2)

  • Garcia-Palacios A, Hoffman H, Carlin A, Furness TA 3rd, Botella C. Virtual reality in the treatment of spider phobia: a controlled study. Behav Res Ther. 2002 Sep;40(9):983-93. doi: 10.1016/s0005-7967(01)00068-7.

    PMID: 12296495BACKGROUND

  • Freeman D, Reeve S, Robinson A, Ehlers A, Clark D, Spanlang B, Slater M. Virtual reality in the assessment, understanding, and treatment of mental health disorders. Psychol Med. 2017 Oct;47(14):2393-2400. doi: 10.1017/S003329171700040X. Epub 2017 Mar 22.

    PMID: 28325167BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersInfertility

Condition Hierarchy (Ancestors)

Mental DisordersGenital DiseasesUrogenital Diseases

Study Officials

  • NAZLI CATAK, MSc

    PRINCIPAL INVESTIGATOR

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
Principal Investigator

Study Record Dates

First Submitted

June 3, 2025

First Posted

June 13, 2025

Study Start

March 1, 2025

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

June 13, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

CY(1)