The Effect of Virtual Reality and Eye Mask During Dressing After CABG Surgery (CABG)

June 25, 2025 updated by: Tugce Bozkurt Elmas, Istanbul University - Cerrahpasa

The Effect of Virtual Reality and Eye Mask Application During Dressing After Coronary Artery Bypass Graft Surgery on Sternotomy Pain, Anxiety, and Physiological Parameters

This study aims to evaluate the effects of virtual reality (VR) and eye mask (EM) applications on pain, anxiety, and physiological parameters during dressing after Coronary Artery Bypass Graft (CABG) surgery.

Postoperative dressing procedures, especially after sternotomy, often cause significant pain and anxiety in patients. These issues can negatively impact recovery and increase the need for medication. Non-pharmacological interventions such as VR and EM may help reduce these symptoms.

In this randomized controlled trial, 90 patients are divided into three groups: VR group, EM group, and a control group receiving standard care. Pain and anxiety levels are monitored baseline, immediately after, and 15 minutes after both the first and second dressing procedures. Physiological parameters are measured baseline, during, immediately after, and 15 minutes after both dressing procedures. Additionally, analgesic use is followed baseline and immediately after each dressing procedure. The study is conducted in a cardiovascular intensive care unit in Istanbul, Türkiye. It is expected that the findings will support the integration of VR and EM as effective, low-cost, and non-invasive options for postoperative care, improving patient comfort and healthcare quality.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled experimental study investigates the effects of virtual reality (VR) and eye mask (EM) applications on sternotomy pain, anxiety, and physiological parameters during postoperative dressing following Coronary Artery Bypass Graft (CABG) surgery.Pain and anxiety during dressing procedures after CABG surgery can negatively affect the recovery process, increase stress responses, prolong hospital stays, and raise the need for medication. Non-pharmacological interventions such as VR and EM are considered effective strategies for managing these symptoms.

The study includes 90 patients, randomly assigned to one of three groups: VR Group: Patients watched 360-degree nature-themed videos using a virtual reality headset during dressing. EM Group: Patients wore an eye mask during dressing. Control Group: Patients received standard care without any additional intervention. The study is being conducted in the Cardiovascular Surgery Intensive Care Unit of a public hospital located in Istanbul, Türkiye.

Inclusion criteria include adult patients undergoing CABG for the first time, ASA classification I-II-III, fully conscious, oriented, cooperative, and willing to provide informed consent. Exclusion criteria include patients with infections or complications, psychiatric disorders, or sensory impairments such as hearing or vision problems. Pain and anxiety levels are assessed at three time points during both the first and second dressing procedures: baseline, immediately after dressing, and 15 minutes after dressing. Physiological parameters (blood pressure, pulse rate, respiratory rate, oxygen saturation) are measured at four time points: baseline, immediately after dressing, and 15 minutes after dressing. Analgesic use is recorded baseline and immediately after each dressing. This study is one of the first to compare VR and EM interventions in the context of high-risk, postoperative cardiac surgery. The results are expected to contribute to evidence-based nursing practices, improve patient comfort in the postoperative period, and support the use of cost-effective, drug-free alternatives for pain and anxiety management in clinical care.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Marmara
      • Istanbul, Marmara, Turkey
        • Recruiting
        • Prof. Dr. Cemil Taşcıoğlu City Hospital
        • Contact:
        • Principal Investigator:
          • Ayfer Özbaş, Professor
        • Principal Investigator:
          • Tuğçe Bozkurt Elmas, PhD (c)
        • Sub-Investigator:
          • Öykü Kara, PhD (c)
        • Sub-Investigator:
          • İsmail Haberal, Professor
        • Sub-Investigator:
          • Müge Sezek, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18-65 years
  • First-time coronary artery bypass graft (CABG) surgery for coronary artery disease
  • ASA physical status I, II, or III
  • Conscious, oriented, and cooperative
  • Able to communicate verbally
  • Provided written informed consent

Exclusion Criteria:

  • Presence of sternal wound infection or inflammation
  • Intubated at the time of assessment
  • Undergoing revision surgery
  • Receiving anesthesia or sedation in the ICU
  • Experiencing intraoperative or postoperative complications
  • Inability to speak Turkish
  • Hearing or visual impairment
  • Diagnosed psychiatric or cognitive disorder
  • Diagnosis of epilepsy
  • Body mass index (BMI) ≥ 30
  • Participation in another clinical trial during the same period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality Group
Participants in this group will watch 360-degree nature-themed videos through a virtual reality headset (Oculus meta quest 2) during both the first and second sternotomy dressing procedures.
Device: Virtual Reality Headset
During the dressing change, nature-themed videos will be shown through a virtual reality headset that immerses the user in a 360-degree, three-dimensional virtual environment.
Experimental: Eye Mask Group
Participants in this group will wear an eye mask during both the first and second sternotomy dressing procedures.
Device: Eye Mask
A soft, adjustable, 3D-structured eye mask (Poblex brand) will be applied during the dressing procedure.
No Intervention: Control Group
Participants in this group will receive standard postoperative care during dressing, with no additional interventions applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS)
Time Frame: Baseline, immediately after, and 15 minutes after first and second dressing
Pain intensity will be measured using the Visual Analog Scale (VAS) at three time points: before, immediately after, and 15 minutes after both the first and second sternotomy dressing procedures.
Baseline, immediately after, and 15 minutes after first and second dressing
State-Trait Anxiety Inventory (STAI-II)
Time Frame: Baseline, immediately after, and 15 minutes after first and second dressing
State anxiety levels (STAI-I) will be measured before, immediately after, and 15 minutes after both the first and second dressing procedures. Trait anxiety (STAI-II) will be measured only once, before surgery.
Baseline, immediately after, and 15 minutes after first and second dressing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiological Parameters (Blood pressure)
Time Frame: Baseline, during, immediately after, and 15 minutes after first and second dressing
Blood pressure will be monitored using a monitor device.
Baseline, during, immediately after, and 15 minutes after first and second dressing
Physiological Parameters (Pulse)
Time Frame: Baseline, during, immediately after, and 15 minutes after first and second dressing
Pulse will be monitored using a monitoring device.
Baseline, during, immediately after, and 15 minutes after first and second dressing
Physiological Parameters (SpO₂)
Time Frame: Baseline, during, immediately after, and 15 minutes after first and second dressing
Saturation values will be monitored using a monitoring device.
Baseline, during, immediately after, and 15 minutes after first and second dressing
Physiological Parameters (Respiratory rate )
Time Frame: Baseline, during, immediately after, and 15 minutes after first and second dressing
Respiratory rate will be monitored using a monitoring device.
Baseline, during, immediately after, and 15 minutes after first and second dressing

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic Use Frequency
Time Frame: Baseline and immediately after first and second dressing
Analgesic agents administered in the intensive care unit, including their names, routes of administration, dosages, and timing, will be systematically documented.
Baseline and immediately after first and second dressing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa

Collaborators

Prof. Dr. Cemil Tascıoglu City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2025

Primary Completion (Estimated)

August 30, 2025

Study Completion (Estimated)

August 30, 2025

Study Registration Dates

First Submitted

June 3, 2025

First Submitted That Met QC Criteria

June 25, 2025

First Posted (Estimated)

June 26, 2025

Study Record Updates

Last Update Posted (Estimated)

June 26, 2025

Last Update Submitted That Met QC Criteria

June 25, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CABG-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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