NCT07891299

Brief Summary

he purpose of this clinical trial is to evaluate whether virtual reality can reduce pain, anxiety, and physiological stress during chest tube removal in adult patients undergoing coronary artery bypass graft (CABG) surgery. The main questions it aims to answer are:

  • Does virtual reality reduce pain intensity during chest tube removal?
  • Does virtual reality reduce anxiety levels and stabilize vital signs? Researchers will compare patients receiving virtual reality with patients receiving routine care to determine whether virtual reality improves patient comfort during the procedure. Participants will:
  • Be randomly assigned to a virtual reality group or a control group
  • Have their pain, anxiety, and vital signs measured before the procedure
  • Undergo chest tube removal with or without virtual reality
  • Have their pain, anxiety, and vital signs measured again after the procedure

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 5, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2026

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 23, 2026

Completed
Last Updated

October 23, 2026

Status Verified

October 1, 2026

Enrollment Period

1.1 years

First QC Date

October 15, 2026

Last Update Submit

October 22, 2026

Conditions

Keywords

Coronary Artery BypassSurgeryVirtual RealityPainVital SignsAnxiety

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity (VAS)

    Pain intensity is assessed using the Visual Analog Scale (VAS), with scores ranging from 0 to 10. A score of 0 indicates no pain, while a score of 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.

    Immediately before and immediately after chest tube removal

Secondary Outcomes (1)

  • Anksiyete - State-Trait Anxiety Inventory (STAI-State)

    Before chest tube removal (baseline) and immediately after completion of chest tube removal (post-intervention).

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

Patients in the experimental group received a virtual reality intervention using a virtual reality headset during chest tube removal following coronary artery bypass graft surgery, in addition to standard care. The intervention was designed to reduce pain and anxiety associated with chest tube removal.

Device: VR Shinecon G04EA Virtual Reality Headset

Control Group

NO INTERVENTION

Control

Interventions

Participants in the experimental group receive a virtual reality intervention using the VR Shinecon G04EA virtual reality headset, which displays immersive nature videos accompanied by audio. The intervention begins 5 minutes before chest tube removal and continues throughout the procedure. The virtual reality headset is used as a non-pharmacological distraction method to reduce pain and anxiety associated with chest tube removal. The intervention is administered in addition to routine postoperative care in the cardiovascular intensive care unit following coronary artery bypass graft surgery.

Virtual Reality Group

Eligibility Criteria

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

You may qualify if:

  • Age between 18 and 65 years
  • Undergoing coronary artery bypass graft surgery
  • Presence of chest tube
  • Conscious and oriented
  • Able to communicate in Turkish
  • Voluntarily agrees to participate

You may not qualify if:

  • Chronic pain condition requiring regular analgesic use
  • Migraine, vertigo, or history of dizziness
  • Visual impairment preventing VR use
  • Psychiatric disorders
  • Undergoing different cardiac surgical procedures
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maltepe University

Istanbul, 0000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist Prof.

Study Record Dates

First Submitted

October 15, 2026

First Posted

October 23, 2026

Study Start

December 5, 2024

Primary Completion

January 5, 2026

Study Completion

March 2, 2026

Last Updated

October 23, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Locations