Clinical trial NCT03922009: The Effect of Virtual Reality on Patients With Anxiety Over Surgeries Under Spinal Anesthesia
Official title: The Effect of Virtual Reality on Patients With Anxiety Over Surgeries Under Spinal Anesthesia-A Case Study of Orthopedic Lower Limb Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Keywords: Virtual Reality；Anxiety
Lead sponsor: National Yang Ming Chiao Tung University Hospital
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 93
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 50 people in the control group 50 people in the experimental group
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Anxiety
timeFrame: After anesthesia until the end of surgery(intraoperative )
Secondary outcomes:
measure: physiological parameters
timeFrame: After anesthesia until the end of surgery(intraoperative )
measure: physiological parameters
timeFrame: After anesthesia until the end of surgery(intraoperative )
measure: physiological parameters
timeFrame: After anesthesia until the end of surgery(intraoperative )
Other outcomes:
measure: sedative drugs
timeFrame: After anesthesia until the end of surgery(intraoperative )
Locations:
city: Yilan City
country: Taiwan
facility: National Yang-Ming University Hospital
state: Yilan County
Study officials:
affiliation: National Yang Ming Chiao Tung University Hospital
name: HSIN-CHIEH YANG, Bachelor
role: PRINCIPAL_INVESTIGATOR
References: