NCT06346730

Brief Summary

This study will conduct as a randomized pretest-posttest study to examine the effect of virtual reality glasses (VRG) application during the IUI procedure on anxiety and patient satisfaction. The population of the research will consist of women who were treated with assisted reproductive techniques and underwent IUI at the infertility polyclinic of Ministry of Health Adana City Training and Research Hospital between May and December 2024 and who meet the research criteria. The research sample was calculated as a total of 90 people (at least 45 people in each group) using the power program. Data; Personal Information Form, Visual Assessment Scale (VAS), State Trait Anxiety Inventory (STAI) and Patient's Perception of Nursing Care Scale will be collected from women who agree to participate in the research. Virtual reality glasses will be applied to the intervention group.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 4, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

May 15, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

March 29, 2024

Last Update Submit

April 7, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • State Trait Anxiety Inventory (STAI)

    State Trait Anxiety Inventory (STAI) was designed to identify individuals' persistent anxiety and the level of anxiety felt towards the situation they are in. A total score between 20 and 80 can be obtained from both scales. Measuring ranges; 20-39 points are considered mild, 40-59 points are considered moderate, 60-79 points are considered severe anxiety, and 80 points are considered panic.

    The research period for a participant takes approximately 30 minute

  • Patient's Perception of Nursing Care Scale

    The Anxiety Inventory was designed to identify individuals' constant anxiety and the level of anxiety they feel about their current situation. A minimum of 15 and a maximum of 75 points can be obtained from the scale. An increase in the total score obtained from the scale indicates that the patient is satisfied with the nursing care.

    The research period for a participant takes approximately 30 minute

Study Arms (2)

Virtual reality glasses to intervention group

EXPERIMENTAL

Virtual reality glasses to intervention group, randomized pretest-posttest

Device: Virtual reality glasses to intervention group

control

NO INTERVENTION

Non-intervention

Interventions

experimental and control ,a randomized pretest-posttest study to examine

Virtual reality glasses to intervention group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age group
  • Primary infertile,
  • Able to speak and understand Turkish,
  • Are cognitive, effective and have no problems preventing communication,
  • Having no psychiatric problems,
  • Not diagnosed with epilepsy (due to the possibility of virtual reality (VR) glasses triggering epileptic seizures),
  • Women who volunteer to participate in the study will be recruited.

You may not qualify if:

  • Having a psychiatric problem,
  • Diagnosed with epilepsy
  • Those who want to leave the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety DisordersPatient Satisfaction

Condition Hierarchy (Ancestors)

Mental DisordersTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Evşen ÇU NAZİK, professor

    Cukurova University

    STUDY CHAIR
  • Ayşe Sevim SU Akbay Kısa, Ph.D

    Suleyman Demirel University

    STUDY CHAIR
  • Ebru Var

    Adana City Training and Research Hospital

    STUDY CHAIR
  • Sefa ARLIER, professor

    Adana City Training and Research Hospital

    STUDY CHAIR

Central Study Contacts

Seda ÇU KARAÇAY YIKAR, assist

CONTACT

Ayşe Sevim SU Akbay Kısa, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The sample will divide into intervention and control groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

March 29, 2024

First Posted

April 4, 2024

Study Start

May 15, 2024

Primary Completion

August 30, 2024

Study Completion

September 30, 2024

Last Updated

April 9, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share