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

Not Applicable

Completed

• Conditions: Virtual Reality

• Registration Number: NCT03922009
• Lead Sponsor: National Yang Ming Chiao Tung University Hospital

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.

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 Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2019-01-19
• Study First Submitted QC: 2019-04-18
• Study First Posted: 2019-04-19
• Primary Completion: 2019-06-01
• Study Completion: 2019-06-01
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-30
• Last Update Posted: 2019-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anxiety	After anesthesia until the end of surgery(intraoperative )	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

Secondary Outcome Measures

Name	Time	Method
physiological parameters	After anesthesia until the end of surgery(intraoperative )	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.

Trial Locations

Locations (1)

National Yang-Ming University Hospital; 🇨🇳 Yilan City, Yilan County, Taiwan