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

VIRTUAL REALITY Clinical Trial

— VR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03475810
• Other study ID #: DerinceTRH-02
• Status: Completed
• Phase: N/A
• Start date: November 7, 2017
• Est. completion date: July 1, 2018

Study information

• Verified date: September 2023
• Source: Derince Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• VIRTUAL REALITY

Intervention

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

Drug:
• Midazolam
1-2 mg midazolam will be administered before spinal punction performed.

Locations

Country	Name	City	State
Turkey	Derince Research and Training Hospital	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Derince Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	State Anxiety Test	State Anxiety test will be perform at postop care unit	postoperative 20th min.
Secondary	Total tolerance time of Virtual Reality glasses	Total tolerance to VR glasses will be recorded	intraoperative
Secondary	incidence of vomiting	incidence of vomiting due to VR glasses	intraoperative
Secondary	incidence of nausea	incidence of nausea due to VR glasses	intraoperative
Secondary	incidence of dizziness	incidence of dizziness due to VR glasses	intraoperative
Secondary	incidence of headache	incidence of headache due to VR glasses	intraoperative
Secondary	Postoperative Visual Analog Scale Score	Patient will be asked his anxiety level by Visual analog scale (VAS) from 0 to 10. 0(= no anxiety), 10(= highest level of anxiety)	postoperative 20 th min.
Secondary	change in mean arterial pressure	blood pressure of the patient will be measured noninvasively from proper extremity in the operating room	5th min. intraoperative
Secondary	change in mean arterial pressure	blood pressure of the patient will be measured noninvasively from proper extremity in the operating room	10th min. intraoperative
Secondary	change in mean arterial pressure	blood pressure of the patient will be measured noninvasively from proper extremity in the operating room	15th min. intraoperative
Secondary	change in mean arterial pressure	blood pressure of the patient will be measured noninvasively from proper extremity in the operating room	20th min. intraoperative
Secondary	change in heart rate	heart rate of the patient will be monitored and recorded	5th min. intraoperative
Secondary	change in heart rate	heart rate of the patient will be monitored and recorded	10th min. intraoperative
Secondary	change in heart rate	heart rate of the patient will be monitored and recorded	15th min. intraoperative
Secondary	change in heart rate	heart rate of the patient will be monitored and recorded	20th min. intraoperative
Secondary	change in respiratory rate	respiratory rate of the patient will be monitored and recorded	5th min. intraoperative
Secondary	change in respiratory rate	respiratory rate of the patient will be monitored and recorded	10th min. intraoperative
Secondary	change in respiratory rate	respiratory rate of the patient will be monitored and recorded	15th min. intraoperative
Secondary	change in respiratory rate	respiratory rate of the patient will be monitored and recorded	20th min. intraoperative