Virtual Pain Care Trial

Pain Clinical 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05772468
• Other study ID #: NL82360.029.22
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 20, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: March 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 190
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Wound
• Wound and Injuries
• Wounds and Injuries

Intervention

Device:
• Virtual Reality ('VRelax' VR system)
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.

Locations

Country	Name	City	State
Netherlands	Amsterdam University Medical Center	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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''.	Baseline, during the procedure, immediately after procedur
Secondary	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''.	Baseline, during the procedure, immediately after procedure
Secondary	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.	Baseline, 10 minutes after procedure
Secondary	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''.	Through study completion, an average of 1 week
Secondary	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''.	Through study completion, an average of 1 year
Secondary	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)	Baseline, 5 minutes after procedure
Secondary	Change of systolic blood pressure and diastolic blood pressure during procedure	The systolic blood pressure and diastolic blood pressure every 5 minutes during procedure	During procedure
Secondary	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)	Baseline, 5 minutes after procedure
Secondary	Change of blood oxygen level during procedure	The blood oxygen level, measured using a pulse oximetry device, every 5 minutes during procedure	During procedure
Secondary	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)	Baseline, 5 minutes after procedure
Secondary	Change of pulse rate during procedure	The pulse rate every 5 minutes during procedure	During procedure
Secondary	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)	Baseline, 5 minutes after procedure
Secondary	Change of respiratory rate during procedure	The respiratory rate every 5 minutes during procedure	During procedure