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

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ClinicalTrials.gov Identifier: NCT03922009
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
YANG,HSIN-CHIEH, National Yang-Ming 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.


Condition or disease Intervention/treatment Phase
Virtual Reality Device: Virtual Reality Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 50 people in the control group 50 people in the experimental group
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of Virtual Reality on Patients With Anxiety Over Surgeries Under Spinal Anesthesia-A Case Study of Orthopedic Lower Limb Surgery
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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



Primary Outcome Measures :
  1. Anxiety [ Time Frame: 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 :
  1. physiological parameters [ Time Frame: After anesthesia until the end of surgery(intraoperative ) ]
    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.

  2. physiological parameters [ Time Frame: After anesthesia until the end of surgery(intraoperative ) ]
    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.

  3. physiological parameters [ Time Frame: 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.


Other Outcome Measures:
  1. sedative drugs [ Time Frame: After anesthesia until the end of surgery(intraoperative ) ]
    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



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03922009


Contacts
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Contact: HSIN-CHIEH YANG, Bachelor 886-3-9325192 ext 19011 11247@ymuh.ym.edu.tw
Contact: XIN-YI LEE 886-3-9325192 ext 72259 irb@ymuh.ym.edu.tw

Locations
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Taiwan
National Yang-Ming University Hospital Recruiting
Yilan City, Yilan County, Taiwan, 26042
Contact: HSIN-CHIEH YANG, Bachelor    +886-3-9325192 ext 19011    11247@ymuh.ym.edu.tw   
Sponsors and Collaborators
National Yang-Ming University Hospital
Investigators
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Principal Investigator: HSIN-CHIEH YANG, Bachelor National Yang-Ming University Hospital

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Responsible Party: YANG,HSIN-CHIEH, National Yang-Ming University Hospital
ClinicalTrials.gov Identifier: NCT03922009     History of Changes
Other Study ID Numbers: NYMUH-IRB No.2018A015
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by YANG,HSIN-CHIEH, National Yang-Ming University Hospital:
Virtual Reality;Anxiety

Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs