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

NCT07039812 | Recruiting

• 1 other identifier: CABG-15
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

CABG; Physiological Parameter; Postoperative Pain; Postoperative Anxiety; Coronary Artery Disease

Keywords

Coronary Artery Bypass Graft; Virtual Reality; Eye Mask; Pain Management; Anxiety; Physiological Parameter

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale (VAS)

  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)

  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 Outcomes (4)

• Physiological Parameters (Blood pressure)

  Baseline, during, immediately after, and 15 minutes after first and second dressing

• Physiological Parameters (Pulse)

  Baseline, during, immediately after, and 15 minutes after first and second dressing

• Physiological Parameters (SpO₂)

  Baseline, during, immediately after, and 15 minutes after first and second dressing

• Physiological Parameters (Respiratory rate )

  Baseline, during, immediately after, and 15 minutes after first and second dressing

Other Outcomes (1)

• Analgesic Use Frequency

  Baseline and immediately after first and second dressing

Study Arms (3)

Virtual Reality Group

EXPERIMENTAL

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

Eye Mask Group

EXPERIMENTAL

Participants in this group will wear an eye mask during both the first and second sternotomy dressing procedures.

Device: Eye Mask

Control Group

NO INTERVENTION

Participants in this group will receive standard postoperative care during dressing, with no additional interventions applied.

Interventions

Virtual Reality Headset DEVICE

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.

Virtual Reality Group

Eye Mask DEVICE

A soft, adjustable, 3D-structured eye mask (Poblex brand) will be applied during the dressing procedure.

Eye Mask Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: collaborator

Study Sites (1)

Prof. Dr. Cemil Taşçıoğlu City Hospital

Istanbul, Marmara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Coronary Artery Disease; Agnosia; Anxiety Disorders

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Mental Disorders

Central Study Contacts

Tuğçe Bozkurt Elmas, PhD (c)

CONTACT

905063137927; tugce.bozkurt10@ogr.iuc.edu.tr

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: PhD Candidate

Model Details: Participants are randomly assigned to one of three parallel arms: VR intervention, eye mask intervention, or standard care control.

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 26, 2025
• Study Start: February 24, 2025
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)