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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).

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Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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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
What is being tested?
Virtual Reality Glasses
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.

Turkey (Türkiye)1 site
  • Dokuz Eylul University

    Izmir

Other trials in Turkey (Türkiye)

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 groups in NCT07843511
Study groupRoleWhat they receive
Virtual Reality GroupExperimentalFor 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 GroupNo interventionPatients 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.

  1. 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)
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  1. First posted28 Sep 2026
  2. Study start23 Sep 2026 (estimated)
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

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)
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

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