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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDokuz Eylul University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

• Under 18 years of age

With vision or hearing loss

Clinically unstable

With a known history of epilepsy, vertigo, or limited mobility

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual Reality Glasses

    Behavioral

    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.

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Virtual Reality GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

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.

Other outcomes

Sponsors and contacts

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