CABGCABGNCT07039812
The Effect of Virtual Reality and Eye Mask During Dressing After CABG Surgery
A study testing Virtual Reality Headset and Eye Mask in people with CABG and Physiological Parameter, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- CABG, Physiological Parameter, Postoperative Pain
- What is being tested?
- Virtual Reality Headset and Eye Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Feb 2025to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Prof. Dr. Cemil Taşçıoğlu City Hospital
Istanbul, Marmara
Tuğçe Bozkurt Elmas, PhD(c), 905063137927, tugce.bozkurt10@ogr.iuc.edu.tr
Ayfer Özbaş, Professor
About this study
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
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.
Read the 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.
- Conditions
- CABG, Physiological Parameter, Postoperative Pain, Postoperative Anxiety, Coronary Artery Disease
- Being tested
- Virtual Reality Headset, Eye Mask
- Keywords
- Coronary Artery Bypass Graft, Virtual Reality, Eye Mask, Pain Management, Anxiety, Physiological Parameter
- Medical subject headings
- Pain, Postoperative, Coronary Artery Disease, Agnosia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality HeadsetDevice
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 MaskDevice
A soft, adjustable, 3D-structured eye mask (Poblex brand) will be applied during the dressing procedure.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Eye Mask |
| Control Group | No intervention | Participants in this group will receive standard postoperative care during dressing, with no additional interventions applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, immediately after, and 15 minutes after first and second dressing
Secondary outcomes (4)
Physiological Parameters (Blood pressure)
Blood pressure will be monitored using a monitor device.
Measured: Baseline, during, immediately after, and 15 minutes after first and second dressing
Physiological Parameters (Pulse)
Pulse will be monitored using a monitoring device.
Measured: Baseline, during, immediately after, and 15 minutes after first and second dressing
Physiological Parameters (SpO₂)
Saturation values will be monitored using a monitoring device.
Measured: 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.
Measured: Baseline, during, immediately after, and 15 minutes after first and second dressing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start24 Feb 2025
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CABGStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of three parallel arms: VR intervention, eye mask intervention, or standard care control.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Responsible party
- Principal investigator, Tugce Bozkurt Elmas, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039812
- Sponsor's protocol ID
- CABG-15
- Acronym
- CABG
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07039812
- Acronym / sponsor ID
- CABG / CABG-15
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants are randomly assigned to one of three parallel arms: VR intervention, eye mask intervention, or standard care control.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Device: Virtual Reality HeadsetParticipants 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. |
| Eye Mask Group | Experimental | Device: Eye MaskParticipants in this group will wear an eye mask during both the first and second sternotomy dressing procedures. |
| Control Group | No intervention | –Participants in this group will receive standard postoperative care during dressing, with no additional interventions applied. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality HeadsetDuring 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 | Virtual Reality Group |
| Eye MaskA soft, adjustable, 3D-structured eye mask (Poblex brand) will be applied during the dressing procedure. | Device | Eye Mask Group |
Primary outcome
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.
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for CABG
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction
Active, not recruiting
Investigation of the Effects of Respiratory Muscle Training Combined With Otago Exercises in Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery
Coronary Artery Bypass Graft (CABG)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Headset and Eye Mask in people with CABG and Physiological Parameter, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuğçe Bozkurt Elmas, PhD (c) (905063137927, tugce.bozkurt10@ogr.iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: Baseline, immediately after, and 15 minutes after first and second dressing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.