- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02986464
Virtual Reality Distraction for Procedural Pain Management in Children With Burn Injuries: a Randomized Controlled Trial
Procedural pain is the most intense and often undertreated pain associated with burn injuries. The use of analgesics does not always provide optimal relief and is accompanied by several side effects. Indeed, children with burn injuries still experience severe pain intensity during procedures despite the fact that doses of analgesics used with this population has almost doubled in the last twenty years. Current guidelines on pediatric procedural pain management recommend the combination of non-pharmacological and pharmacological interventions to enhance pain management and decrease the numerous side effects of analgesics. Distraction has been identified among the most effective non-pharmacological interventions for pain as it diverts the child's attention to an attractive element, hindering the perception of the painful stimuli. Virtual reality is a method of active distraction that offers the child a multi-sensory immersive interaction that found many applications for pain management in adult patients. However, very few studies have tested the efficacy of distraction by virtual reality on procedural pain and anxiety in children with burn injuries.
This RCT follows a pilot study (NCT02794103) aimed at assessing the feasibility of a virtual reality prototype developed specifically for the hydrotherapy room of children under seven years old for the relief of procedural pain in children with burn injuries. The aim of the RCT will be to evaluate the effectiveness of the virtual reality prototype in relieving procedural pain in children from 6 months to 7 years old undergoing hydrotherapy session for burn injuries.
Study Overview
Status
Intervention / Treatment
Detailed Description
BACKGROUND:
Preliminary data from the pilot study showed that the virtual reality prototype installed around the tank in the hydrotherapy room is a feasible and acceptable method of distraction that doesn't interfere with the work of healthcare professionals and could be used as a non-pharmacological method for pain management. A clinical trial is needed to assess the effectiveness of this intervention for procedural pain relief. The pilot study was also informative about the feasibility of the study design and the measurement used. The methods section was modified and adapted consequently for the upcoming trial.
METHODS:
Design: Within-subject/crossover study design. Each child will serve as their own control and will receive both standard and experimental treatment during the same hydrotherapy session through a randomized order.
Sample and Setting: Convenience sampling on the surgical-trauma burn unit at CHU Ste-Justine, of children admitted to the unit or to the day hospital for a burn injury. The intervention will take place in the hydrotherapy room of the CHU Ste-Justine.
Interventions. A) Standard pharmacological treatment as per the unit's protocol. B) VR distraction through the use of a virtual reality prototype installed around the tank in the hydrotherapy room. The prototype has been developed in collaboration with the Society of Arts and Technology (SAT) in Montreal to provide an immersive interactive experience for the burn child in the hydrotherapy tank. The prototype was developed after several meetings between the researchers, the designers and engineers and the surgical trauma team of CHU Ste-Justine. Meetings were followed by an ergonomic study of the hydrotherapy room to meet the unit's and patients' specifications and ensure that it doesn't interfere with the healthcare professionals work.The video games were developed by our team with a personalized care content tailored to the children's developmental stage and to maximize the feeling of immersion and minimize cybersickness, and approved by a team of healthcare professionals in pediatric burn care.
Study proceedings: Hydrotherapy sessions typically last between 20 to 40 minutes. The duration will be divided into two sequences of the same duration (10 to 20 minutes) where the participant receives the same care by the same healthcare professional. For one sequence, only the standard treatment will be administered and for the other sequence, patients will receive the standard treatment in addition to Virtual Reality via the screen around the tank in a randomized order.
Measures: Pain and anxiety measures will be taken before the treatment session at Baseline (T1), in the middle of the first sequence of the session (T2) and in the middle of the second sequence of the session (T3) followed by a measure of healthcare professionals' satisfaction level via a questionnaire developed and pretested by the team after the session (T4). Data will be collected on the average doses of analgesics administered before and during the session, and the side effects experienced.
Data analysis: Quantitative analysis. Mean differences in pain scores between sequences will be compared using Wilcoxon test.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3T 1C4
- CHU Ste. Justine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- suffer from a burn injury requiring a hydrotherapy session
- presence of a consenting parent who can understand, read and write either French or English
Exclusion Criteria:
- Requiring intensive care
- Having a diagnosed cognitive impairment
- Are unconscious or intubated during the hydrotherapy sessions
- Suffering from epilepsy (considering the nature of the intervention)
- Allergic to opioids or other analgesics used for standard pharmacological treatment
- Having burn injuries on the face preventing them from looking at the VR screen
Will be excluded in posteriori from analysis children sedated for more than 50% of the time during one or both study sequences (score of 3 or 4 on the University of Michigan Sedation Scale).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Standard pharmacological treatment
|
According to the unit's protocol and adjusted to each participant's age, weight and condition by the anesthetist and the pain clinic nurse.
|
EXPERIMENTAL: Virtual Reality distraction
|
VR prototype installed around the tank in the hydrotherapy room to give the child a sense of immersion in the virtual world with a possibility of interaction depending on the child's age and condition.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Pain Score
Time Frame: T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)
|
French version of the Face, Legs, Activity, Cry and Consolability (FLACC)
|
T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Pain Score - Observational/Behavioral Complementary measure
Time Frame: T1: baseline; T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)
|
Visual Analog Scale by proxy
|
T1: baseline; T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)
|
Comfort
Time Frame: T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)
|
Behavioural observation scale of comfort level for child burn victims (OCCEB- BECCO)
|
T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)
|
Sedation
Time Frame: T1: baseline; T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)
|
University of Michigan Sedation Scale (UMSS)
|
T1: baseline; T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)
|
Health professionals' satisfaction level
Time Frame: T4: immediately after the procedure before leaving the hydrotherapy room
|
Pre-tested tailored questionnaire including tolerance, positive and negative aspects
|
T4: immediately after the procedure before leaving the hydrotherapy room
|
Analgesic requirement
Time Frame: T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)
|
Rescue dose medication administration
|
T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christelle Khadra, RN, PhD (c), Université de Montreal; CHU Ste-Justine Research Center
- Study Director: Sylvie Le May, RN, PhD, Université de Montreal; CHU Ste-Justine Research Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-1382
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
Clinical Trials on Standard Pharmacological Treatment
-
Paul CrawfordCompleted
-
Hospital Clinic of BarcelonaUnknown
-
Hospices Civils de LyonTerminatedAnal IncontinenceFrance
-
BaroPace Inc.JSS Medical Research Inc.RecruitingHypertension | Heart Failure With Preserved Ejection Fraction (HFpEF)India
-
Yale UniversityNational Institutes of Health (NIH)Completed
-
The University of Hong KongNot yet recruitingStroke | Small Vessel Cerebrovascular Disease
-
St. Justine's HospitalQuebec Nursing Intervention Research NetworkCompletedPain | Burns | Child | Anxiety | InjuriesCanada
-
Pharmazz, Inc.CompletedHypovolemic ShockIndia
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaRecruitingThoracic Cancer | Palliative Care | RadiotherapyItaly
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaRecruitingPelvic Cancer | Palliative Care | RadiotherapyItaly