Virtual Reality for pain and fear relief in wound care

ISRCTN	ISRCTN16621834
DOI	https://doi.org/10.1186/ISRCTN16621834
Secondary identifying numbers	S63103

Submission date: 15/03/2021
Registration date: 01/04/2021
Last edited: 06/04/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Virtual Reality (VR) assisted wound care procedures may reduce pain and fear in patients undergoing these procedures. Additionally the use of VR technology may mean that patients need less pain relief and anxiety reducing medication than conventional wound care without VR. This has been shown in several focused studies with a small patient sample size (less than 50 participants). Use of VR is limited by the availability of resources in daily clinical care and therefore the number of patients who have the potential to be treated with VR remains unknown.

This study will assess children and adults admitted to theUZLeuven Intensive Care and Burn Unit for good candidates for successful VR application, where clinical care, human resources, and logistics to provide VR technology will be available for the study period. This study will identify the clinical and psychological characteristics of the best candidate-patients for VR during wound care, and will compare patient anxiety, fear, and drug requirements during VR-assisted wound care procedures to conventional wound care procedures. This will allow the study team to estimate the potential effect size of the intervention and to model the potential health economic impact of generalized implementation in Belgian Burn centers.

The study team also hope to will broaden the study to evaluate the maximum range of motion (ROM) during passive joint movement by a research physiotherapist with and without VR assistance. Furthermore, the study team may extend the study to evaluate the long-term medical and psychological outcome of this study cohort.

Who can participate?
Child and adult patients admitted to the UZLeuven Intensive Care and Burn Unit or patients selected in Pediatric Intensive Care Unit, Outpatient Burn Care, or Emergency Department who require wound care

What does the study involve?
All selected participants will receive Virtual Reality (VR) which can provide simple distraction through a film or game or VR-assisted hypnosis. The VR-technology will be explained and applied by trained study collaborators on the day before the planned wound care procedure. Participants will be evaluated for their anxiety, fear, and drug requirements during the wound care procedure and asked if they would choose VR assistance again during (hypothetical) subsequent wound care sessions.

What are the possible benefits and risks of participating?
Potential benefits of participating are a reduction in the experience of pain and fear and reduced requirements for pain relief and sedation before wound care procedures. VR may also help with movement of the affected limb. There is a limit risk that VR may induce nausea.

Where is the study run from?
The UZLeuven Intensive Care and Burn Unit (Belgium)

When is the study starting and how long is it expected to run for?
From January 2020 to December 2022

Who is funding the study?
The Flemish Government, Department of Innovation (Belgium) and the Leuven University Hospitals (Belgium)

Who is the main contact?
Prof. Dr. Michael Casaer, michael.casaer@uzleuven.be

Study website

Contact information

Prof Michael Casaer
Scientific

University Hospitals (UZLeuven/KULeuven)
Catholic University Leuven
Herestraat 49
Leuven
3000
Belgium

ORCID ID	0000-0002-7087-0795
Phone	+32 16348786
Email	Michael.Casaer@UZLeuven.be

Study information

Study design	Prospective non-randomized interventional study within a project of improvement of quality of clinical care
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	ISRCTN16621834_PIS.docx
Scientific title	Determination of size and characteristics of the target population for the successful application of Virtual Reality during painful (wound) procedures: a prospective non-randomized interventional study
Study acronym	VR-BWC-I
Study objectives	1. To quantify and characterize (clinically and psychologically) the proportion of patients admitted to the Burn Center eligible for successful VR therapy during wound care. Successful VR defined as the patient accepting VR and completing the entire wound care procedure under VR assistance and would choose again for VR assistance during (hypothetical) subsequent wound care session(s). 2. Non-randomized estimation of the potential magnitude of the impact of VR-assisted wound care procedures on pain, fear, analgesic and anxiolytic drug needs based on patients who underwent both VR-assisted and (for logistical reasons) “conventional” procedures.
Ethics approval(s)	Approved 03/12/2019, Ethical Committee UZ/KULeuven (Herestraat 49, B-3000 Leuven, Belgium; +32 16348600; ec@uzleuven.be), ref: s63103 B322201941190
Health condition(s) or problem(s) studied	Burns and other traumatic, infectious, or immune-mediated skin and soft tissue lesions
Intervention	All participants will receive Virtual Reality (VR) aimed at inducing distraction and/or dissociation and reducing procedural pain and fear. VR-technology will be explained and applied by trained study collaborators on the day before the planned wound care procedure. The VR-material in this project is the Oncomfort Sedokit, it is designed and approved for medical sedation. The Sedokit can provide simple distraction through a film or game or VR-assisted hypnosis. Successful VR defined as the patient accepting VR and completing the entire wound care procedure under VR assistance and would choose again for VR assistance during (hypothetical) subsequent wound care session(s). Non-responders include patients in whom VR “is technically possible, but is not accepted by the patient (and/or proxies) or in whom the entire wound care procedure cannot be completed under VR assistance.” Upon inclusion in the study the following baseline clinical data will be collected: 1. Demographics 2. Wound specific parameters, including Laser Doppler Scan Imaging (LDI) assessment (if available) of wound surface and healing potential, clinician-estimated Burned Surface Area (BSA) in % of total body surface area (TBSA), location and mechanism of burn, trauma or disease provoking the lesion, and the number of days since the initial wound occurred and since burn center admission will be registered. 2. Self-control assessed in a standardized manner by a short, age-adapted introduction, question, and answers on a Likert scale. The result will be registered directly in the eCRF. 3. Socio economic status (SES) will be addressed through the KWS Clinical Work Station social module , including highest educational degree, salary or other income , living together or not, and feeling supported by cohabitants or not 4. Psychological variables assessing anxiety, traumatic stress, and depression will be collected. For these variables, validated questionnaires will be presented to patients and stored in My Nexus (clinical file) as primary source and the appropriate summary data will be manually or automatically transferred to the eCRF: 4.1. The Mini Mental State Examination (MMSE) will evaluate cognitive problems among patients >18 years 4.2. Post Traumatic Stress Disorder (PTSD) will be assessed with the Impact of Event Scale (IES) 4.3. Common mental disorders will be assessed with the Composite International Diagnostic Interview- Screening Scales (CIDI-SC) that assesses DSM-5 criteria for common mental disorders such as major depressive disorder, panic disorder, or generalized anxiety disorder 4.4. The Alcohol Use Disorders Identification Test (AUDIT) will be used to identify patients engaging in “risky or hazardous drinking” and to identify patients with “risk for alcohol dependence” 4.5. Among minors, the Strength and Difficulties Questionnaire (SDQ) will be administered in order to assess emotional problems 4.6. The Child Trauma Screening Questionnaire (CTSQ) will be used for participants aged 6-16 years old. Participants will be assessed using self-reported questionnaires administered via My Nexus. In case of patient difficulties with filling out these questionnaires, a research collabroator will assist patients administering the questionnaires and obtaining self-reported data. Answering the surveys will take each patient around 20 mins. The automatic data collection for psychological variables will be implemented into the NEXUS framework of UZLeuven and will be following the same process as the one in the Leuven College Surveys for which approval of the ethical committee was granted in the past. If the My Nexus platform is not be ready at the initiation of the study, the answers to the questions will be stored on standardized forms that will be securely stored and entered a posteriori into the platform. Applicable scores and components will be transferred from NEXUS to the eCRF.
Intervention type	Device
Pharmaceutical study type(s)
Phase	Phase IV
Drug / device / biological / vaccine name(s)
Primary outcome measure	1. Proportion of patients successfully completing procedures with VR within all patients admitted measured from eCRF records collected at the end of the study 2. Fraction of wound care procedures successfully conducted with VR within all procedures measured from eCRF records collected at the end of the study 3. Predictability of successful VR based on psychological variables and baseline clinical characteristics measured using scored in real time by the study psychologist or study nurse in the eCRF after the procedure
Secondary outcome measures	1. Extent to which the patient has the experience to be present in “another world” due to diverted attention (potentially related to analgesic and anxiolytic effect) measured using the question "To what extent did you feel you ‘went into” the virtual world?" (not at all/not really/undecided/somewhat/very much) after each procedure 2. Persistence of the analgesic and anxiolytic effect and patient satisfaction in patients undergoing multiple VR sessions measured using the questions "To what extent did you feel the VR equipment was easy to use?" (not at all/not really/undecided/somewhat/very much), "Have you enjoyed the VR session?" (not at all/not really/undecided/somewhat/very much), "How satisfied were you with the virtual reality system during your dressing change?" (not at all/not really/undecided/somewhat/very much), and "If you would need wound care tomorrow would you like to have VR assistance again?” (yes/no, if no participants will be asked to provide the reason why not) after each procedure; participants will also be asked for their overall satisfaction with the VR equipment (not at all/not really/undecided/somewhat/very much) at the end of the study 3. Healthcare provider satisfaction with VR measured using the following at the end of the study: 3.1. Nurse satisfaction measured using the questions "To what extent did you feel the VR equipment was easy to use?" (not at all/not really/undecided/somewhat/very much) and "To what extent did you feel the VR equipment interfered with clinical care?" (not at all/not really/undecided/somewhat/very much) 3.2. Physiotherapists’ satisfaction (only for procedures with research physiotherapists available) measured using the questions "To what extent did you feel the VR equipment was easy to use?" (not at all/not really/undecided/somewhat/very much) and "To what extent did you feel the VR equipment interfered with clinical care?" (not at all/not really/undecided/somewhat/very much) 4. Detailed Patient and Caregiver satisfaction with VR measured in a convenience sample at the end of the study 5. In patients who undergo repeated procedures with and without VR-assistance the following will be measured: 5.1. Difference in drug requirements recorded in the Patient Data Management System (PDMS) during the procedure 5.2. Observed and self-reported pain and anxiety measured using: 5.2.1. The numeric rating scale for anxiety (NRS-A) and numeric rating scale for pain (NRS-P) during the procedure, the FLACC (Face, Legs, Activity, Cry, Consolability) scale will be used before, during, and after the procedure 5.2.2. For children, the Faces Pain Scale, and fear thermometer during the procedure 5.3. Heart Rate and Respiratory Rate monitored in the Patient Data Management System (PDMS) from the bedside/procedure room monitor and minimal and maximal levels recorded throughout the procedure 6. Potential Health Economy impact based on differences in drug requirements and on the material and HR-related costs for providing VR to all eligible patients On condition that a research physiotherapist is financed: 1. Difference in obtained Range Of Motion (ROM) measured by the study physiotherapist during passive joint mobilization in a selected subgroup of patients On condition of additional funding: 1. Patient physical recovery, emotional well-being, residual pain and discomfort, presence of PTSD, and feeling of self-control measured using a short survey at 6 months
Overall study start date	06/01/2020
Completion date	31/12/2022

Eligibility

Participant type(s)	Patient
Age group	Mixed
Sex	Both
Target number of participants	200 to 300 patients
Key inclusion criteria	1. Mental age ≥6 years 2. Need for wound care 3. Admitted to E519 (Burn center unit) or ad-hoc patients selected in Pediatric Intensive Care Unit, Outpatient Burn Care, or Emergency Department 4. Able to communicate in Dutch, English, French language
Key exclusion criteria	1. Deaf 2. Blind 3. Schizophrenia, advanced dementia, dissociative disorder, or serious claustrophobia 3. Lesions exclusively in the facial area, precluding VR application during wound care 4. Permanent hypoesthesia in the affected area 5. No informed consent given
Date of first enrolment	06/01/2020
Date of final enrolment	31/12/2022

Locations

Countries of recruitment

Belgium

Study participating centre

UZLeuven

University Hospitals Catholic University Leuven
Herestraat 49
Leuven
3000
Belgium

Sponsor information

Universitair Ziekenhuis Leuven
Hospital/treatment centre

Herestraat 49
Leuven
3000
Belgium

Phone	+32 (0)16348786
Email	michael.casaer@uzleuven.be
Website	https://www.uzleuven.be/en
"ROR"	https://ror.org/0424bsv16

Funders

Funder type

Government

Vlaamse regering
Government organisation / National government

Alternative name(s): Flanders, Flemish Government, Flandre, Flandern, Vlaanderen
Location: Belgium

Universitaire Ziekenhuizen Leuven, KU Leuven
Private sector organisation / Other non-profit organizations

Alternative name(s): University Hospital Leuven, KU Leuven, UZ Leuven
Location: Belgium

Results and Publications

Intention to publish date	30/06/2023
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Stored in repository
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal. The project will also result in operational recommendations regarding human resources and material required to provide virtual reality during wound care to all patients likely to benefit from it.
IPD sharing plan	The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository The research database (eCRF) will be hosted on the University Hospitals Leuven servers. This closed network is only accessible for employees and affiliated persons which have to use a personal login and password to log into the system. Equipment can only have access to the network after registration/installation by the central ICT service. The hospital network is protected by a firewall but authorized research staff can access the network over the internet using a secure SSL-solution with one-time passwords (using a Vasco Digipass or Google Authenticator). The firewall and external access procedure has been audited and approved by Ubizen and Deloitte. The research database resides on the central servers with mirrored or RAID5 system disks and has hourly backups. The database is written in FilemakerPro and is login/password protected. An access log and audit trail are available. For reasons of data integrity and internal control name and hospital number are stored in a separate table linked to the eCRF, but these data will be only accessible for the concerned Research staff and the principal database manager on a login/password base. When the database is finalized, those data will be detached from the eCFR and stored at the local site No data will be made available unconditionally in the public space. The participant level data of this clinical study will not be publicly available. This would be a potential source of erroneous findings due to inadequate interpretation of the study design and would not be covered by the consent given by the patients. The data will be stored in the research database of the Clinical Department and Laboratory of Intensive Care Medicine and request for post-hoc analyses with a clearly defined research question and methodology can be sent to the investigators. Email Michael.casaer@uzleuven.be This approach to avoid misinterpretation of complex data and databases has been proposed in a recent summit on data sharing organized by the NEJM in April 2017 where Prof. Dr. Greet Van den Berghe Chair of the Clinical Department and Laboratory of Intensive Care Medicine contributed.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet			06/04/2021	No	Yes

Additional files

ISRCTN16621834_PIS.docx: Uploaded 06/04/2021

Editorial Notes

06/04/2021: The participant information sheet has been uploaded.
19/03/2021: Trial’s existence confirmed by Leuven University Hospitals Ethical Committee.