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出境医 / 临床实验 / 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

Study Description
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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 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
Actual Primary Completion Date : June 1, 2019
Actual Study Completion Date : June 1, 2019
Arms and Interventions
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
Outcome Measures
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


Eligibility Criteria
Layout table for eligibility information
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.
Contacts and Locations

Locations
Layout table for location information
Taiwan
National Yang-Ming University Hospital
Yilan City, Yilan County, Taiwan, 26042
Sponsors and Collaborators
National Yang Ming Chiao Tung University Hospital
Investigators
Layout table for investigator information
Principal Investigator: HSIN-CHIEH YANG, Bachelor National Yang Ming Chiao Tung University Hospital
Tracking Information
First Submitted Date  ICMJE January 19, 2019
First Posted Date  ICMJE April 19, 2019
Last Update Posted Date September 3, 2019
Actual Study Start Date  ICMJE June 1, 2018
Actual Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 18, 2019)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effect of Virtual Reality on Patients With Anxiety Over Surgeries Under Spinal Anesthesia
Official Title  ICMJE The Effect of Virtual Reality on Patients With Anxiety Over Surgeries Under Spinal Anesthesia-A Case Study of Orthopedic Lower Limb Surgery
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Virtual Reality
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Device: Virtual Reality
  • No Intervention: control group
    General routine care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 30, 2019)
93
Original Estimated Enrollment  ICMJE
 (submitted: April 18, 2019)
100
Actual Study Completion Date  ICMJE June 1, 2019
Actual Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03922009
Other Study ID Numbers  ICMJE NYMUH-IRB No.2018A015
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party YANG,HSIN-CHIEH, National Yang Ming Chiao Tung University Hospital
Study Sponsor  ICMJE National Yang Ming Chiao Tung University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: HSIN-CHIEH YANG, Bachelor National Yang Ming Chiao Tung University Hospital
PRS Account National Yang Ming Chiao Tung University Hospital
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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