The Effect of Virtual Reality on Patients With Anxiety Over Surgeries Under Spinal Anesthesia

NCT03922009 | Completed

• 1 other identifier: NYMUH-IRB No.2018A015
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

The main purposes of this study are as follows: First, to understand the effect of virtual reality on the subjective feelings of anxiety in patients with orthopaedic lower limb surgery for spinal anesthesia. Second, to understand the effects of virtual reality on the systolic blood pressure, diastolic blood pressure, mean arterial pressure, heartbeat, respiration and other physiological parameters in the operation of orthopedic lower extremity surgery patients with spinal anesthesia. Third, to understand the effect of using virtual reality in surgery to reduce the use of sedative drugs and the degree of pain in patients with orthopedic lower extremity surgery.

Conditions

Virtual Reality

Keywords

Virtual Reality；Anxiety

Outcome Measures

Primary Outcomes (1)

• Anxiety

  First, to understand the effect of virtual reality on the subjective feelings of anxiety in patients with orthopaedic lower limb surgery for spinal anesthesia.USE State-Trait Anxiety Inventory；STAI

  After anesthesia until the end of surgery(intraoperative )

Secondary Outcomes (3)

• physiological parameters

  After anesthesia until the end of surgery(intraoperative )

• physiological parameters

  After anesthesia until the end of surgery(intraoperative )

• physiological parameters

  After anesthesia until the end of surgery(intraoperative )

Other Outcomes (1)

• sedative drugs

  After anesthesia until the end of surgery(intraoperative )

Study Arms (2)

Virtual Reality group

EXPERIMENTAL

The primary objective of this study was to evaluate the use of VR to reduce anxiety in spinal anesthesia patients compared with controls

Device: Virtual Reality

control group

NO INTERVENTION

General routine care

Interventions

Virtual Reality DEVICE

The primary objective of this study was to evaluate the use of VR to reduce anxiety in spinal anesthesia patients compared with controls

Virtual Reality group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• population: acceptance of lower extremity fractures in patients with spinal anesthesia.
• Anesthesia classification (ASA): I-III.
• Age: 20 years old to 70 years of age.

You may not qualify if:

• Mental illness and taking related drugs.
• Visually impaired and hearing impaired.
• Being unable to communicate or illiterate.
• The condition changes or is critical, and the intensive care unit is admitted after the operation.
• Contact isolation.
• Trauma of the head and wounds on the head.
• History of motion sickness and vertigo.

Sponsors & Collaborators

• National Yang Ming Chiao Tung University Hospital: lead

Study Sites (1)

National Yang-Ming University Hospital

Yilan, Yilan County, 26042, Taiwan

Location

Study Officials

• HSIN-CHIEH YANG, Bachelor

  National Yang Ming Chiao Tung University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: National Yang-Ming University Hospital

Model Details: 50 people in the control group 50 people in the experimental group

Study Record Dates

• First Submitted: January 19, 2019
• First Posted: April 19, 2019
• Study Start: June 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: September 3, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)