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Completed

NCT Number: NCT06244654

Anxiolytic Effectiveness of Virtual Reality Glasses in Surgery

Regional anesthesia allows surgery without affecting the patient's level of consciousness.However, this may cause anxiety in some patients.In previous research, scientists have tried to prevent anxiety with non-pharmacological interventions such as music and cognitive therapies.Virtual reality is thought to offer an immersive experience that can alter the mind's perception of pain. Scientists have found in previous preliminary studies that virtual reality is safe and effective as an adjunct to standard sedative/analgesic protocols for reducing patients' pain and anxiety during endoscopy, colonoscopy, dental treatments, burn dressings, and labor. In this study, it is expected that anxiety scores, postoperative analgesic need and intraoperative sedation need will decrease, recovery quality will improve and patient satisfaction will increase in patients who will undergo upper extremity surgery under regional anesthesia and watch videos through VR glasses.

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Key information

Conditions

Anesthesia Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Postoperative Recovery Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara City Hospital

Ankara, Cankaya, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • who will undergo upper extremity surgery under regional anesthesia

Exclusion criteria

  • being under 18 years old
  • Those who do not have the ability to read, understand and sign the consent form
  • An active infection or open wound in the face or eye area
  • History of seizures due to an epileptic condition or any other reason
  • Planning to wear a hearing aid during the surgical procedure
  • Having a pacemaker or other implanted medical device
  • Migraine
  • Having an infectious condition that is transmitted through droplets or airborne
  • not knowing Turkish
  • Not deemed suitable for the approach by the surgeon
  • History of psychosis or claustrophobia
  • Being visually and/or hearing impaired

Treatment and study plan

Oculus Quest 2 VR virtual reality glasses and wired over-ear headphones

Device

After the VR group comes to the preoperative area and is evaluated, they will be asked to wear VR glasses and headphones. VR glasses and headphones were worn on the patient during peripheral nerve block applications and the operation. At the end of the operation, the VR glasses and headphones were removed and they were taken to the postoperative recovery room.

No VR

Other

After evaluation of the patients taken to the preoperative area, routine peripheral nerve block application was performed without the use of VR glasses. VR glasses were not worn during the operation, as is the routine protocol. At the end of the surgery, they were taken to the postoperative recovery room.

Other names: Control group

Primary outcomes

  1. State-Trait Anxiety Scale

    Time frame: Preoperative, Postoperative 4.hour

    preoperative and postoperative STAI I and II score questions will be asked.

Secondary outcomes

  1. systolic blood pressure

    Time frame: Preoperative, İntraoperative 0 min, İntraoperative 60min, End of Operation, Postoperative 4.hour

    non invasive systolic blood pressure measurement

  2. diastolic blood pressure

    Time frame: Preoperative, İntraoperative 0 min, İntraoperative 60min, End of Operation, Postoperative 4.hour

    non invasive diastolic blood pressure measurement

  3. mean arterial pressure

    Time frame: Preoperative, İntraoperative 0 min, İntraoperative 60min, End of Operation, Postoperative 4.hour

    mean blood pressure measurement

  4. heart rate

    Time frame: Preoperative, İntraoperative 0 min, İntraoperative 60min, End of Operation, Postoperative 4.hour

    intraoperatif and perioperatif ecg monitarization

  5. oxygen saturation

    Time frame: Preoperative, İntraoperative 0 min, İntraoperative 60min, End of Operation, Postoperative 4.hour

    intraoperatif and perioperative pulse oxymeter measurement

  6. aditional analgesic requirement

    Time frame: postoperative up to 24 hour

    postoperative additional analgesic requirement

  7. VAS score

    Time frame: Postoperative 1.hour, 4.hour., 12.hour., 24hour.

    A blinded evaluator will evaluate the visual analog scale score.

  8. Patient satisfaction scale

    Time frame: Postoperative 4.hour

    A blinded evaluator will evaluate the Patient satisfaction scale

  9. Surgeon satisfaction scale

    Time frame: Postoperativ 1.hour

    A blinded evaluator will evaluate the surgeon satisfaction scale

  10. The quality of recovery-15 (QoR-15)

    Time frame: Preoperative, Postoperative 24.hour

    A blinded evaluator will evaluate the QoR-15 scale.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Anxiolytic Effectiveness of Virtual Reality Glasses in Upper Extremity Surgery

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 6, 2024
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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