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

The Effect of Virtual Reality on Patients With Anxiety Over Surgeries Under Spinal Anesthesia-A Case Study of Orthopedic Lower Limb Surgery

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.

Study Overview

• Status: Completed
• Conditions: Virtual Reality
• Intervention / Treatment: Device: Virtual Reality

Detailed Description

Surgery is a serious source of stress for the general patient and can increase the patient's anxiety. which is It is normal to show obvious anxiety in patients undergoing surgery, but if the degree of anxiety is serious, it may lead Negative physiological manifestations, such as slow wound healing, increase the risk of infection and may affect the induction of anesthesia It requires more anesthesia dose during surgery, which hinders recovery time. Most studies have confirmed surgery Playing music in the room can alleviate the anxiety and pain of the patients, but the music preference is subjective and some people like it.

There must be people who hate it, and the operating room is not a quiet space. There are many sound sources in the operating room., such as the sound of surgical instruments, the warning sound of physiological monitors, the voice of the staff, these It will be a source of anxiety for patients. Instrument noise averages up to 60 decibels, including neurosurgery, orthopedics It can even exceed 100 decibels. Foreign scholars believe that playing music at this time will only aggravate the noisy environment.The attention of the staff. Therefore, it is hoped that by using virtual reality to provide images and sounds during surgery, hijacking The patient's auditory, visual, and proprioception creates an immersive, distracting approach that reduces the cause of the ring Anxiety brought by the environment helps spinal anesthesia patients to reduce anxiety during surgery and increase psychological comfort To reduce the use of sedative drugs during surgery.

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Yilan County
    • Yilan City, Yilan County, Taiwan, 26042
      • National Yang-Ming University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality group; 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; The primary objective of this study was to evaluate the use of VR to reduce anxiety in spinal anesthesia patients compared with controls
No Intervention: control group; General routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
physiological parameters	Second, to understand the effects of virtual reality on the mean arterial pressure physiological parameters in the operation of orthopedic lower extremity surgery patients with spinal anesthesia.	After anesthesia until the end of surgery(intraoperative )
physiological parameters	Second, to understand the effects of virtual reality on the heartbeat physiological parameters in the operation of orthopedic lower extremity surgery patients with spinal anesthesia.	After anesthesia until the end of surgery(intraoperative )
physiological parameters	Second, to understand the effects of virtual reality on the respiration physiological parameters in the operation of orthopedic lower extremity surgery patients with spinal anesthesia.	After anesthesia until the end of surgery(intraoperative )

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
sedative drugs	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.USE Numerical Rating Scale；NRS	After anesthesia until the end of surgery(intraoperative )

Collaborators and Investigators

• Sponsor: National Yang Ming Chiao Tung University Hospital
• Investigators: Principal Investigator: HSIN-CHIEH YANG, Bachelor, National Yang Ming Chiao Tung University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: January 19, 2019
• First Submitted That Met QC Criteria: April 18, 2019
• First Posted (Actual): April 19, 2019

Study Record Updates

• Last Update Posted (Actual): September 3, 2019
• Last Update Submitted That Met QC Criteria: August 30, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Virtual Reality；Anxiety
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: NYMUH-IRB No.2018A015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No