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NCT Number: NCT07039812

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prof. Dr. Cemil Taşçıoğlu City Hospital

Istanbul, Marmara, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ayfer Özbaş, Professor

PRINCIPAL_INVESTIGATOR

Müge Sezek, MSc

SUB_INVESTIGATOR

Tuğçe Bozkurt Elmas, PhD (c)

PRINCIPAL_INVESTIGATOR

Tuğçe Bozkurt Elmas, PhD(c)

CONTACT

[email protected]

905063137927

Öykü Kara, PhD (c)

SUB_INVESTIGATOR

İsmail Haberal, Professor

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

eye mask

Device

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tuğçe Bozkurt Elmas, PhD (c)

CONTACT

[email protected]

905063137927

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Collaborators

  • Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Registry information

Official study 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

Acronym: CABG

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 26, 2025
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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