Pain After SurgeryNCT07843511
The Effect of Virtual Reality Headsets on Pain, Anxiety, Patient Satisfaction, and Physiological Parameters in Patients Undergoing Open-Heart Surgery
A study testing Virtual Reality Glasses in people with Pain After Surgery and Pain and Anxiety, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain After Surgery, Pain and Anxiety, Anxiety After Surgery
- What is being tested?
- Virtual Reality Glasses
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Sep 2026to Mar 2027
- Phase
- Interventional
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Being tested
- Virtual Reality Glasses
- Keywords
- Virtual Reality, Open Heart Surgery, Physiological Parameters, Pain, Anxiety, Patient Satisfaction, Non-pharmacological Intervention
- Medical subject headings
- Pain, Anxiety Disorders, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality GlassesBehavioural
Also called VR Glasses
One day before surgery, the researcher will have participants in this group complete the State Anxiety Scale and the Satisfaction Scale. On the second 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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | 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 second 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. Receives: Behavioral: Virtual Reality Glasses |
| Control Group | No intervention | 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 second 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 being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
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.
Measured: The second day after surgery, immediately before the procedure, immediately after the procedure, and 30 minutes later.
Secondary outcomes (6)
Preoperative and postoperative anxiety levels
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.
Measured: 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
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.
Measured: 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
Systolic blood pressure will be measured in millimeters of mercury (mmHg). Higher values indicate higher systolic blood pressure.
Measured: On the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
Diastolic Blood Pressure
Diastolic blood pressure will be measured in millimeters of mercury (mmHg). Higher values indicate higher diastolic blood pressure.
Measured: On the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
Pulse Rate
Pulse rate will be measured in beats per minute (beats/min).
Measured: On the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
Respiratory Rate
Respiratory rate will be measured in breaths per minute (breaths/min).
Measured: On the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start23 Sep 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain After SurgeryStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gizem Göktuna, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843511
- Sponsor's protocol ID
- 2026/21-18
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No