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

NCT ID: NCT03922009

Last Updated: 2019-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2019-06-01

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.

Conditions

Virtual Reality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: DEVICE

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

control group

General routine care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Yang Ming Chiao Tung University Hospital

OTHER

Sponsor Role: lead

Responsible Party

YANG,HSIN-CHIEH

National Yang-Ming University Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

HSIN-CHIEH YANG, Bachelor

Role: PRINCIPAL_INVESTIGATOR

National Yang Ming Chiao Tung University Hospital

Locations

National Yang-Ming University Hospital

Yilan, Yilan County, Taiwan

Countries

Taiwan

Other Identifiers

NYMUH-IRB No.2018A015

Identifier Type: -

Identifier Source: org_study_id