- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07843511
The Effect of Virtual Reality Headsets on Pain, Anxiety, Patient Satisfaction, and Physiological Parameters in Patients Undergoing Open-Heart Surgery
The Effect of Virtual Reality Headsets on Pain, Anxiety, Patient Satisfaction, and Physiological Parameters in Patients Undergoing Open-Heart Surgery: A Randomized Controlled Trial
This randomized controlled trial aims to investigate the effects of virtual reality headset use on pain, anxiety, patient satisfaction, and physiological parameters in patients undergoing open-heart surgery. Participants will be randomly assigned to two groups: the virtual reality group and the control group. Pain levels, anxiety levels, satisfaction levels, and physiological parameters will be assessed both before and after the procedure. The study aims to determine whether this non-pharmacological method improves postoperative pain, anxiety, patient satisfaction, and physiological parameters.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Izmir, Turkey (Türkiye)
- Recruiting
- Dokuz Eylul University
-
Contact:
- Principal Investigator
- Phone Number: +90 232 412 4779
- Email: gizemgoktuna@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 18 and older
- Who have not previously undergone open-heart surgery
- Non-emergency, elective surgeries
- Who have not taken pain medication 4-6 hours prior to the procedure
- Who have a numerical pain scale score of 3 or higher prior to the procedure
- Patients with sufficient cognitive ability to tolerate the virtual reality headset application
- Patients who voluntarily agree to participate in the study
- Patients extubated on the second postoperative day
- Patients with no history of chronic pain (e.g., arthritis)
- Being alert and oriented enough to communicate (Glasgow Coma Scale 15)
- Not being addicted to alcohol or drugs
- Not using anxiolytics
- Having no psychological problems (such as depression or anxiety disorders)
- Being able to read and understand Turkish
Exclusion Criteria:
-
• Under 18 years of age
- With vision or hearing loss
- Clinically unstable
- With a known history of epilepsy, vertigo, or limited mobility
- With a surgical incision or scar on the face that prevents wearing VR goggles
- Chronic opioid use or use of psychiatric medications
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual Reality Group
For patients admitted to the ward for surgery, the researcher will have them complete the State Anxiety Scale and the Satisfaction Scale one day before surgery. On the third postoperative day in the clinic, the researcher will fit patients with virtual reality goggles, and the patient will watch nature-themed videos-such as forest scenes, beach walks, and parks-for 10 minutes. After 10 minutes, the virtual reality session will end. Immediately after the intervention and 30 minutes later, the same researcher will have the patients complete the Numerical Pain Scale, the State Anxiety Scale, the Numerical Satisfaction Scale, and the Physiological Parameters Monitoring Form. |
One day before surgery, the researcher will have participants in this group complete the State Anxiety Scale and the Satisfaction Scale. On the third postoperative day at the clinic, the researcher will fit patients with virtual reality goggles, and the patient will watch nature-themed videos-such as forest scenes, beach walks, and parks-for 10 minutes. After 10 minutes, the virtual reality session will end. Immediately after the intervention and 30 minutes later, the same researcher will have the patients complete the Numerical Pain Scale, the State Anxiety Scale, the Numerical Satisfaction Scale, and the Physiological Parameters Monitoring Form. This distraction technique aims to reduce pain perception and anxiety levels, increase patient satisfaction during the procedure, and improve physiological parameters.
Other Names:
|
|
No Intervention: Control Group
Patients admitted to the ward for surgery will complete the State Anxiety Scale and the Satisfaction Scale administered by the researcher one day before surgery. Patients will be admitted to the clinic on the third postoperative day, and their care will continue to be provided by the nurse responsible for their care as part of routine clinical practice. The researcher will not perform any additional interventions. At the same time as the group receiving the virtual reality headset intervention, the researcher will again have patients complete the Numerical Pain Scale, State Anxiety Scale, Numerical Satisfaction Scale, and Physiological Parameters Monitoring Form. (Measurements will be taken during the preoperative period; however, patients who do not meet the inclusion criteria postoperatively will not be included in the study.) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative pain
Time Frame: The second day after surgery, immediately before the procedure, immediately after the procedure, and 30 minutes later.
|
Pain intensity will be measured using a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain) immediately after the procedure. Measurements will be taken three times: on the second day after surgery, immediately before the procedure, immediately after the procedure, and 30 minutes later. |
The second day after surgery, immediately before the procedure, immediately after the procedure, and 30 minutes later.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preoperative and postoperative anxiety levels
Time Frame: One day before surgery; the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
|
Anxiety levels will be assessed using the State Anxiety Inventory-Short Form (STAIS-S). The scale measures temporary anxiety levels. Scores range from 20 to 80. Measurements will be taken four times: one day before surgery; on the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure. Higher scores indicate higher (worse) anxiety. |
One day before surgery; the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
|
|
Pre- and post-surgery satisfaction levels
Time Frame: One day before surgery; the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
|
Patient satisfaction will be assessed using a Visual Analog Scale (VAS) ranging from 0 (not at all satisfied) to 10 (extremely satisfied). Measurements will be taken four times: one day before surgery; on the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure. Higher scores indicate greater satisfaction. |
One day before surgery; the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
|
|
Systolic Blood Pressure
Time Frame: On the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
|
Systolic blood pressure will be measured in millimeters of mercury (mmHg). Higher values indicate higher systolic blood pressure. |
On the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
|
|
Diastolic Blood Pressure
Time Frame: On the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
|
Diastolic blood pressure will be measured in millimeters of mercury (mmHg). Higher values indicate higher diastolic blood pressure. |
On the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
|
|
Pulse Rate
Time Frame: On the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
|
Pulse rate will be measured in beats per minute (beats/min). |
On the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
|
|
Respiratory Rate
Time Frame: On the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
|
Respiratory rate will be measured in breaths per minute (breaths/min). |
On the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026/21-18
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.