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Not yet recruitingNCT07843511Updated Sep 28, 2026

The Effect of Virtual Reality Headsets on Pain, Anxiety, Patient Satisfaction, and Physiological Parameters in Patients Undergoing Open-Heart Surgery

An interventional study of Virtual Reality Glasses in Pain After Surgery, Pain and Anxiety and Anxiety After Surgery, sponsored by Dokuz Eylul University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Dokuz Eylul University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Pain After Surgery
  • Pain and Anxiety
  • Anxiety After Surgery
  • Anxiety
  • Open Heart Surgery

Keywords

  • Virtual Reality
  • Open Heart Surgery
  • Physiological Parameters
  • Pain
  • Anxiety
  • Patient Satisfaction
  • Non-pharmacological Intervention
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
44 participants (estimated)

Study arms

  • 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 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.

    Behavioral: Virtual Reality Glasses

  • 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 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.)

Interventions

  • BehavioralVirtual Reality 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.

    Also known as: VR Glasses

05

What researchers measure

Primary outcomes

  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.

    Time frame: The second day after surgery, immediately before the procedure, immediately after the procedure, and 30 minutes later.

Secondary outcomes

  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.

    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.

  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.

    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.

  3. Systolic Blood Pressure

    Systolic blood pressure will be measured in millimeters of mercury (mmHg). Higher values indicate higher 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.

  4. Diastolic Blood Pressure

    Diastolic blood pressure will be measured in millimeters of mercury (mmHg). Higher values indicate higher 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.

  5. Pulse Rate

    Pulse rate will be measured in beats per minute (beats/min).

    Time frame: 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).

    Time frame: On the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.

06

Study locations

1 site
  • Dokuz Eylul University
    Izmir, Turkey (Türkiye)
07

Registry details

Key details

Study ID
NCT07843511
Lead sponsor
Dokuz Eylul University
Responsible party
Gizem Göktuna (Assistant Professor, Dokuz Eylul University) — Principal investigator
First posted
Sep 28, 2026
Start date
Sep 23, 2026 (estimated)
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Sep 28, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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