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Completed

NCT Number: NCT03475810

The Effect of Virtual Reality Glasses on Anxiety During Surgery Under Spinal Anesthesia

The aim of the study is to evaluate the efficacy of virtual reality glasses on anxiety of the patients who underwent operations under spinal anesthesia during peroperative period. Both control group and VR group will be carry out STAI- Traıt anxiety test before operation and trait test after operation. Patients will be perform spinal anesthesia after standard sedation administration. After block reach adequate level for operation patients in VR group will wear the glasses and started to watch a documentary about birds and a sedative music by the headset. Patients in Control group will take standard anesthesia care. Hemodynamic changes (systemic blood pressure, heart rate, respiration rate and pSPO2) will be record in both groups.

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Key information

Conditions

Virtual Reality Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Derince Research and Training Hospital

Kocaeli, 41900, Turkey (Türkiye)

About this study

The ASA score I-III Patients undergoing operation in OR under spinal anesthesia will be included in the study. Patients randomly assigned to VR group or Control Group. Patients will be carry out STAI-Trait Anxiety test preoperatively and second STAI test postoperatively. Spinal anesthesia will be performed after standard iv midazolam administration in both groups. After block reach adequate level for operation patient will wear the glasses and started to watch a documentary about birds and a sedative music by the headset in VR group and patient will take standard anesthesia care in Control group. The hemodynamic variables will be recorded during operation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age >18
  • Patients who undergo surgery under spinal anesthesia
  • American Society of Anesthesiologists (ASA) physical status classification I-III

Exclusion criteria

  • patients undergo urgent operations
  • patients have psychiatric disorders

Treatment and study plan

Virtual reality

Device

Patients will wear virtual reality glasses and start watching 3 D video after confirmation of adequate motor and sensorial block.

Other names: VR

midazolam

Drug

1-2 mg midazolam will be administered before spinal punction performed.

Other names: Demizolam

Primary outcomes

  1. State Anxiety Test

    Time frame: postoperative 20th min.

    State Anxiety test will be perform at postop care unit

Secondary outcomes

  1. Total tolerance time of Virtual Reality glasses

    Time frame: intraoperative

    Total tolerance to VR glasses will be recorded

  2. incidence of vomiting

    Time frame: intraoperative

    incidence of vomiting due to VR glasses

  3. incidence of nausea

    Time frame: intraoperative

    incidence of nausea due to VR glasses

  4. incidence of dizziness

    Time frame: intraoperative

    incidence of dizziness due to VR glasses

  5. incidence of headache

    Time frame: intraoperative

    incidence of headache due to VR glasses

  6. Postoperative Visual Analog Scale Score

    Time frame: postoperative 20 th min.

    Patient will be asked his anxiety level by Visual analog scale (VAS) from 0 to 10. 0(= no anxiety), 10(= highest level of anxiety)

  7. change in mean arterial pressure

    Time frame: 5th min. intraoperative

    blood pressure of the patient will be measured noninvasively from proper extremity in the operating room

  8. change in mean arterial pressure

    Time frame: 10th min. intraoperative

    blood pressure of the patient will be measured noninvasively from proper extremity in the operating room

  9. change in mean arterial pressure

    Time frame: 15th min. intraoperative

    blood pressure of the patient will be measured noninvasively from proper extremity in the operating room

  10. change in mean arterial pressure

    Time frame: 20th min. intraoperative

    blood pressure of the patient will be measured noninvasively from proper extremity in the operating room

  11. change in heart rate

    Time frame: 5th min. intraoperative

    heart rate of the patient will be monitored and recorded

  12. change in heart rate

    Time frame: 10th min. intraoperative

    heart rate of the patient will be monitored and recorded

  13. change in heart rate

    Time frame: 15th min. intraoperative

    heart rate of the patient will be monitored and recorded

  14. change in heart rate

    Time frame: 20th min. intraoperative

    heart rate of the patient will be monitored and recorded

  15. change in respiratory rate

    Time frame: 5th min. intraoperative

    respiratory rate of the patient will be monitored and recorded

  16. change in respiratory rate

    Time frame: 10th min. intraoperative

    respiratory rate of the patient will be monitored and recorded

  17. change in respiratory rate

    Time frame: 15th min. intraoperative

    respiratory rate of the patient will be monitored and recorded

  18. change in respiratory rate

    Time frame: 20th min. intraoperative

    respiratory rate of the patient will be monitored and recorded

Sponsors and collaborators

Lead sponsor

Derince Training and Research Hospital

Other

Registry information

Official study title

The Effect of Virtual Reality Glasses on Anxiety During Surgery Under Spinal Anesthesia: A Randomize Controlled Study

Acronym: VR

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 23, 2018
Registry last updated
Sep 7, 2023

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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