Back to resultsVirtual Pain Care Trial
Primary Purpose
Wound, Wound and Injuries, Pain
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Virtual Reality ('VRelax' VR system)
Sponsored by
About this trial
This is an interventional treatment trial for Wound focused on measuring Wound Care, Virtual Reality, Pain management
Eligibility Criteria
Inclusion Criteria: Individuals aged 18 or older with surgical wounds receiving wound care Individuals who will undergo minimum of 1 to a maximum of 3 sequential complex wound care procedures At least 1 prior painful wound care procedure, where they have indicated a VAS ≥ 4, or patients reporting a VAS ≥ 4 before initiating the wound care procedure. Exclusion Criteria: Individuals not being able to understand Dutch language at primary school level Individuals not being able to read or write Dutch Individuals diagnosed with dementia and/or cognitive impairment Individuals diagnosed with epilepsy Individuals diagnosed with autism Individuals diagnosed with migraine Individuals with severe dizziness and/or nausea Individuals with a known history of claustrophobia Individuals who are unable to sign informed consent owing to mental disorder or formally stated to be incompetent to decide Individuals who have no feeling in the wound care area Individuals with >1 wound requiring wound care Individuals with physical (and/or cognitive) disabilities on the face, eye, ear, nose and neck that prevent the use of the VR headgear and/or headphones
Sites / Locations
- Amsterdam University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Virtual Reality Therapy (Intervention group 1)
Care as usual (control group/group 2)
Arm Description
In addition to the standard wound care procedure, the Virtual Reality Therapy group (intervention group 1) will receive the VR system during the wound care. The VR system consists of Virtual Reality glasses, and a headphone. The application VRelax will be used, which will contain various videos for the patient those from to relax and be distracted. This group wears the VR system 10 minutes before the start of the wound care, until 1 minute after the wound care has ended.
The control group (group 2), also known as the care as usual group, receives the standard procedure during wound care without 'VRelax' VR system.
Outcomes
Primary Outcome Measures
The primary outcome is the change in pain score before and after the first wound care, measured with the Visual Analogue Scale (VAS).
The VAS is a horizontal scale from 0 to 10, with 0 indicating ''no pain'' and 10 indicating ''worst pain possible''.
Secondary Outcome Measures
Mean VAS change of all wound care procedures included in the study
The VAS is a horizontal scale from 0 to 10, with 0 indicating ''no pain'' and 10 indicating ''worst pain possible''.
Change from baseline in level of anxiety at 10 minutes after procedure
Level of anxiety, as measured by a Dutch translated and validated modification of the Spielberger State-Trait Inventory-6 (STAI-6) questionnaire 10 minutes before and 10 minutes after each three wound care moments.
Patient satisfaction
Patient satisfaction, as measured by a self-developed Dutch provider satisfaction questionnaire, focuses on satisfaction about the intervention with the VR system or headphone with audio. The questionnaires included a Visual Analogue Scale (VAS). The VAS is a horizontal scale from 0 to 10, with 0 indicating ''the worst score'' and 10 indicating ''the best score'', or with 0 indicating '''the best score'' and 10 indicating ''the worst score''.
Provider satisfaction
Provider satisfaction, as measured by a self-developed Dutch provider satisfaction questionnaire, focuses on satisfaction about the intervention with the VR system or headphone with audio. The questionnaires included a Visual Analogue Scale (VAS). The VAS is a horizontal scale from 0 to 10, with 0 indicating ''the worst score'' and 10 indicating ''the best score'', or with 0 indicating '''the best score'' and 10 indicating ''the worst score''.
Change from baseline systolic blood pressure and diastolic blood pressure at 5 minutes after procedure
The systolic blood pressure and diastolic blood pressure 5 minutes before the intervention (intervention group)/wound care (control group) and 5 minutes after the intervention (intervention group)/wound care (control group)
Change of systolic blood pressure and diastolic blood pressure during procedure
The systolic blood pressure and diastolic blood pressure every 5 minutes during procedure
Change from baseline blood oxygen level at 5 minutes after procedure
The blood oxygen level, measured using a pulse oximetry device, 5 minutes before intervention (intervention group)/wound care (control group), and 5 minutes after the intervention (intervention group)/wound care (control group)
Change of blood oxygen level during procedure
The blood oxygen level, measured using a pulse oximetry device, every 5 minutes during procedure
Change from baseline pulse rate at 5 minutes after procedure
The pulse rate 5 minutes before intervention (intervention group)/wound care (control group), and 5 minutes after the intervention (intervention group)/wound care (control group)
Change of pulse rate during procedure
The pulse rate every 5 minutes during procedure
Change from baseline respiratory rate at 5 minutes after procedure
The respiratory rate 5 minutes before intervention (intervention group)/wound care (control group), and 5 minutes after the intervention (intervention group)/wound care (control group)
Change of respiratory rate during procedure
The respiratory rate every 5 minutes during procedure
Full Information
NCT ID
NCT05772468
First Posted
February 22, 2023
Last Updated
March 15, 2023
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1. Study Identification
Unique Protocol Identification Number
NCT05772468
Brief Title
Virtual Pain Care Trial
Official Title
Virtual Pain Care; the Effectiveness of Virtual Reality Therapy on Reducing Pain, and Anxiety During Complex Wound Care Procedures in Adults With Surgical Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 20, 2023 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The main objective of this study is to evaluate the effect on pain of Virtual Reality Therapy as add-on therapy during wound care procedures in adults.
Detailed Description
After inclusion and completion of the informed consent form, patients are randomly allocated to the intervention group or control group in a 1:1 ratio. Randomization will not be blinded since both the provider and patient know if the patient will be wearing the VR system during wound care or not wearing the VR system.
Patients are randomly assigned to one of two groups:
Group 1 - Intervention group 1, Virtual Reality Therapy Group 2 - Control group, care as usual
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound, Wound and Injuries, Pain
Keywords
Wound Care, Virtual Reality, Pain management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Masking Description
Randomization will not be blinded since both the provider and patient know if the patient will be wearing the VR system during wound care or not wearing the VR system.
Allocation
Randomized
Enrollment
190 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality Therapy (Intervention group 1)
Arm Type
Experimental
Arm Description
In addition to the standard wound care procedure, the Virtual Reality Therapy group (intervention group 1) will receive the VR system during the wound care. The VR system consists of Virtual Reality glasses, and a headphone. The application VRelax will be used, which will contain various videos for the patient those from to relax and be distracted. This group wears the VR system 10 minutes before the start of the wound care, until 1 minute after the wound care has ended.
Arm Title
Care as usual (control group/group 2)
Arm Type
No Intervention
Arm Description
The control group (group 2), also known as the care as usual group, receives the standard procedure during wound care without 'VRelax' VR system.
Intervention Type
Device
Intervention Name(s)
Virtual Reality ('VRelax' VR system)
Intervention Description
The intervention group 1 will be wearing the 'VRelax' Virtual Reality system during the wound care moment in addition to the standard procedure. The VR system consists of Virtual Reality glasses, and a headphone. The VRelax Application will be used.
Primary Outcome Measure Information:
Title
The primary outcome is the change in pain score before and after the first wound care, measured with the Visual Analogue Scale (VAS).
Description
The VAS is a horizontal scale from 0 to 10, with 0 indicating ''no pain'' and 10 indicating ''worst pain possible''.
Time Frame
Baseline, during the procedure, immediately after procedur
Secondary Outcome Measure Information:
Title
Mean VAS change of all wound care procedures included in the study
Description
The VAS is a horizontal scale from 0 to 10, with 0 indicating ''no pain'' and 10 indicating ''worst pain possible''.
Time Frame
Baseline, during the procedure, immediately after procedure
Title
Change from baseline in level of anxiety at 10 minutes after procedure
Description
Level of anxiety, as measured by a Dutch translated and validated modification of the Spielberger State-Trait Inventory-6 (STAI-6) questionnaire 10 minutes before and 10 minutes after each three wound care moments.
Time Frame
Baseline, 10 minutes after procedure
Title
Patient satisfaction
Description
Patient satisfaction, as measured by a self-developed Dutch provider satisfaction questionnaire, focuses on satisfaction about the intervention with the VR system or headphone with audio. The questionnaires included a Visual Analogue Scale (VAS). The VAS is a horizontal scale from 0 to 10, with 0 indicating ''the worst score'' and 10 indicating ''the best score'', or with 0 indicating '''the best score'' and 10 indicating ''the worst score''.
Time Frame
Through study completion, an average of 1 week
Title
Provider satisfaction
Description
Provider satisfaction, as measured by a self-developed Dutch provider satisfaction questionnaire, focuses on satisfaction about the intervention with the VR system or headphone with audio. The questionnaires included a Visual Analogue Scale (VAS). The VAS is a horizontal scale from 0 to 10, with 0 indicating ''the worst score'' and 10 indicating ''the best score'', or with 0 indicating '''the best score'' and 10 indicating ''the worst score''.
Time Frame
Through study completion, an average of 1 year
Title
Change from baseline systolic blood pressure and diastolic blood pressure at 5 minutes after procedure
Description
The systolic blood pressure and diastolic blood pressure 5 minutes before the intervention (intervention group)/wound care (control group) and 5 minutes after the intervention (intervention group)/wound care (control group)
Time Frame
Baseline, 5 minutes after procedure
Title
Change of systolic blood pressure and diastolic blood pressure during procedure
Description
The systolic blood pressure and diastolic blood pressure every 5 minutes during procedure
Time Frame
During procedure
Title
Change from baseline blood oxygen level at 5 minutes after procedure
Description
The blood oxygen level, measured using a pulse oximetry device, 5 minutes before intervention (intervention group)/wound care (control group), and 5 minutes after the intervention (intervention group)/wound care (control group)
Time Frame
Baseline, 5 minutes after procedure
Title
Change of blood oxygen level during procedure
Description
The blood oxygen level, measured using a pulse oximetry device, every 5 minutes during procedure
Time Frame
During procedure
Title
Change from baseline pulse rate at 5 minutes after procedure
Description
The pulse rate 5 minutes before intervention (intervention group)/wound care (control group), and 5 minutes after the intervention (intervention group)/wound care (control group)
Time Frame
Baseline, 5 minutes after procedure
Title
Change of pulse rate during procedure
Description
The pulse rate every 5 minutes during procedure
Time Frame
During procedure
Title
Change from baseline respiratory rate at 5 minutes after procedure
Description
The respiratory rate 5 minutes before intervention (intervention group)/wound care (control group), and 5 minutes after the intervention (intervention group)/wound care (control group)
Time Frame
Baseline, 5 minutes after procedure
Title
Change of respiratory rate during procedure
Description
The respiratory rate every 5 minutes during procedure
Time Frame
During procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Individuals aged 18 or older with surgical wounds receiving wound care
Individuals who will undergo minimum of 1 to a maximum of 3 sequential complex wound care procedures
At least 1 prior painful wound care procedure, where they have indicated a VAS ≥ 4, or patients reporting a VAS ≥ 4 before initiating the wound care procedure.
Exclusion Criteria:
Individuals not being able to understand Dutch language at primary school level
Individuals not being able to read or write Dutch
Individuals diagnosed with dementia and/or cognitive impairment
Individuals diagnosed with epilepsy
Individuals diagnosed with autism
Individuals diagnosed with migraine
Individuals with severe dizziness and/or nausea
Individuals with a known history of claustrophobia
Individuals who are unable to sign informed consent owing to mental disorder or formally stated to be incompetent to decide
Individuals who have no feeling in the wound care area
Individuals with >1 wound requiring wound care
Individuals with physical (and/or cognitive) disabilities on the face, eye, ear, nose and neck that prevent the use of the VR headgear and/or headphones
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marlies Schijven, Prof. dr.
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amsterdam University Medical Center
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105AZ
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
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Virtual Pain Care Trial
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