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

NCT ID: NCT07039812

Last Updated: 2025-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-24

Study Completion Date

2025-08-30

Brief Summary

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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

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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.

Conditions

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CABG Physiological Parameter Postoperative Pain Postoperative Anxiety Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Virtual Reality Headset

Intervention Type 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 Group

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

Group Type EXPERIMENTAL

Eye Mask

Intervention Type DEVICE

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

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eye Mask

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

OTHER

Sponsor Role collaborator

Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Tugce Bozkurt Elmas

PhD Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Prof. Dr. Cemil Taşçıoğlu City Hospital

Istanbul, Marmara, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Tuğçe Bozkurt Elmas, PhD (c)

Role: CONTACT

905063137927

Facility Contacts

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Tuğçe Bozkurt Elmas, PhD(c)

Role: primary

905063137927

Other Identifiers

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CABG-15

Identifier Type: -

Identifier Source: org_study_id

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