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Recruiting NCT07039812

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

No phase Interventional CABG Physiological Parameter Postoperative Pain Postoperative Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality Headset, Eye Mask.
Who it may be relevant to
Registry conditions: CABG, Physiological Parameter, Postoperative Pain, Postoperative Anxiety. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

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

Primary outcome measures

  • Visual Analog Scale (VAS) [Time frame: 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]
Secondary outcome measures (4)
  • Physiological Parameters (Blood pressure) [Time frame: 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]
  • Physiological Parameters (SpO₂) [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Prof. Dr. Cemil Taşçıoğlu City Hospital — Istanbul

Identifiers

NCT: NCT07039812 · CABG-15

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗