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Clinical Trial NCT07039812 (CABG) for CABG, Physiological Parameter, Postoperative Pain, Postoperative Anxiety, Coronary Artery Disease is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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The Effect of Virtual Reality and Eye Mask During Dressing After CABG Surgery 90 Non-Invasive Randomized Virtual

Recruiting
Clinical Trial NCT07039812 (CABG) is an interventional study for CABG, Physiological Parameter, Postoperative Pain, Postoperative Anxiety, Coronary Artery Disease that is recruiting. It started on 24 February 2025 with plans to enroll 90 participants. Led by Istanbul University - Cerrahpasa, it is expected to complete by 30 August 2025. The latest data from ClinicalTrials.gov was last updated on 26 June 2025.
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-pharma...

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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 s...Show More
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

Conditions
CABGPhysiological ParameterPostoperative PainPostoperative AnxietyCoronary Artery Disease
Other Study IDs
  • CABG
  • CABG-15
NCT ID Number
NCT07039812
Start Date (Actual)
2025-02-24
Last Update Posted
2025-06-26
Completion Date (Estimated)
2025-08-30
Enrollment (Estimated)
90
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Coronary Artery Bypass Graft
Virtual Reality
Eye Mask
Pain Management
Anxiety
Physiological Parameter
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalVirtual 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.
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.
ExperimentalEye Mask Group
Participants in this group will wear an eye mask during both the first and second sternotomy dressing procedures.
Eye Mask
A soft, adjustable, 3D-structured eye mask (Poblex brand) will be applied during the dressing procedure.
No InterventionControl Group
Participants in this group will receive standard postoperative care during dressing, with no additional interventions applied.
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Physiological Parameters (Blood pressure)
Blood pressure will be monitored using a monitor device.
Baseline, during, immediately after, and 15 minutes after first and second dressing
Physiological Parameters (Pulse)
Pulse will be monitored using a monitoring device.
Baseline, during, immediately after, and 15 minutes after first and second dressing
Physiological Parameters (SpO₂)
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 )
Respiratory rate will be monitored using a monitoring device.
Baseline, during, immediately after, and 15 minutes after first and second dressing
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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
Istanbul University - Cerrahpasa logoIstanbul University - Cerrahpasa174 active studies to explore
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization logoProf. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Study Responsible Party
Tugce Bozkurt Elmas, Principal Investigator, PhD Candidate, Istanbul University - Cerrahpasa
Study Central Contact
Contact: Tuğçe Bozkurt Elmas, PhD (c), 905063137927, [email protected]
1 Study Locations in 1 Countries

Marmara

Prof. Dr. Cemil Taşçıoğlu City Hospital, Istanbul, Marmara, Turkey (Türkiye)
Tuğçe Bozkurt Elmas, PhD(c), Contact, 905063137927, [email protected]
Ayfer Özbaş, Professor, Principal Investigator
Tuğçe Bozkurt Elmas, PhD (c), Principal Investigator
Öykü Kara, PhD (c), Sub-Investigator
İsmail Haberal, Professor, Sub-Investigator
Müge Sezek, MSc, Sub-Investigator
Recruiting