NCT07068594

Brief Summary

The aim of this study is to examine the effect of virtual reality glasses, a non-pharmacological method used in pain and anxiety management in nursing practices, on the pain, anxiety, and vital parameters perceived by patients undergoing their first dressing change after open heart surgery. Additionally, the study aims to obtain information about the safety of the virtual reality application. The primary questions this study seeks to answer are as follows: Does the virtual reality headset application reduce the pain participants feel during the procedure? Does the application reduce participants' anxiety levels during the procedure? Does the virtual reality application have a positive effect on vital signs (pulse, blood pressure, etc.)? Do participants experience any side effects or medical problems during this application? Researchers will compare the group that received virtual reality glasses during the first dressing change after open-heart surgery with the standard care (control group) to evaluate the effects of the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 15, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed
Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

Same day

First QC Date

July 7, 2025

Last Update Submit

July 16, 2025

Conditions

Keywords

virtual realitypainanxietyheart surgerywound dressingvital signsnursingintensive care unit nursingsurgical nursing

Outcome Measures

Primary Outcomes (1)

  • Pain Severity

    Pain intensity will be assessed using the Visual Analog Scale (VAS). It is a 10 cm scale ranging from 0 (no pain) to 10 (worst possible pain). Measurements were taken before the dressing procedure and 10 minutes after the procedure.

    Immediately before the dressing procedure and 10 minutes after the procedure

Secondary Outcomes (1)

  • Anxiety level

    Immediately before the dressing procedure and 10 minutes after the procedure

Study Arms (2)

Virtual Reality Glasses During the First Dressing Change Usage

EXPERIMENTAL

In this group, virtual reality glasses were used during the procedure for individuals who would have their first dressing changed on the first postoperative day after open heart surgery.

Device: Virtual Reality Goggles

Standard Dressing Procedure without VR

NO INTERVENTION

A standard dressing change procedure was performed on this group.

Interventions

A device consisting of glasses placed on the head of patients in the intervention group and earphones attached to the glasses

Virtual Reality Glasses During the First Dressing Change Usage

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals who verbally or in writing agree to participate in the study,
  • Are over 18 years of age,
  • Have not been diagnosed with any psychiatric disorder and are not using psychiatric medication,
  • Have no visual, auditory, or perceptual impairments,
  • Are undergoing their first wound dressing change following open-heart surgery,

You may not qualify if:

  • Patients who are unconscious,
  • Individuals who have undergone two or more wound dressing changes after open-heart surgery,
  • Patients who report pain due to any other condition,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydin Adnan Menderes University - Institute of Health Sciences

Aydin, Merkez, 09100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

AgnosiaPainAnxiety Disorders

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

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
RN, MSc - Specialist Nurse in Surgical Nursing, Department of Surgical Diseases Nursing, Adnan Menderes University

Study Record Dates

First Submitted

July 7, 2025

First Posted

July 16, 2025

Study Start

January 15, 2024

Primary Completion

January 15, 2024

Study Completion

June 15, 2024

Last Updated

July 20, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Locations