Clinical trial NCT03680625: Virtual Reality vs Passive Distraction for Pain Management
Official title: Virtual Reality Compared to Passive Distraction for Pain Management During Orthopedic Procedures in Children: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Pain
Pain Perception
Pain Management
Anxiety
Catastrophizing, Pain
Stress
Keywords: Virtual reality
Immersive distraction
Virtual world
Virtual environment
Passive distraction
Procedural pain
Procedural anxiety
Acute pain
Pain management
Anxiety
Children, Child
Kid, Kids
Pediatric, Pediatrics
Young children
Orthopedics
Kirschner wire, K pin
Bone wires
Percutaneous pins
Non-pharmacological
Clinical Research
Nursing Practice
User-computer interface
Pediatric Nursing
Hospital, Pediatric
Sutures
Stress
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
Collaborators: name: Montreal Children's Hospital of the MUHC
name: Shriners Hospitals for Children
First posted: 2018-09-21
Enrollment: 188
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel/2 groups
Primary purpose: TREATMENT

Brief summary: Background: Outpatient pediatric orthopedic procedures such as percutaneous pins removal and sutures are considered painful and generate significant stress and anxiety in children. However, given their short duration and the need for a quick turnover in outpatient clinics, there are very few interventions aimed at relieving pain, stress and anxiety related to these procedures. Neither simple analgesia nor topical anesthetics proved effective for procedural pain reduction with this population. Moreover, narcotics and procedural sedation do not appear to be feasible alternatives as they require surveillance, prolonging visit to the outpatient clinic and generating several undesired side effects. Therefore, it would be imperative to explore non-pharmacological pain management methods as they require minimal preparation and do not usually generate any side effects.

Aim: To examine the effect of virtual reality (VR) compared to passive distraction, on pain, stress, anxiety and memory of pain in children undergoing a percutaneous pin removal procedure or sutures in an outpatient orthopedic clinic.

Hypothesis: VR distraction provides better pain relief during percutaneous pin removal procedures or sutures than passive distraction, in children from 7 to 21 years old.

Methods: The study will be a prospective randomized controlled trial with parallel groups. Children from 7 to 21 years old, visiting the clinic for follow up and percutaneous pin removal procedure or sutures, accompanied by a parent or legal guardian will be recruited. The experimental group will receive a VR distraction through a head-mounted Oculus Quest® and the control group will receive passive distraction through watching a video on an iPad®. The primary outcome will be the mean pain score after the procedure (self-report of pain level during the procedure) measured by the Numerical Rating Scale (NRS). Anxiety will be measured by the Child Fear Scale (CFS) and stress will be measured using level of salivary Alpha-Amylase before and 10-min after the procedure. Memories of pain and anxiety will be measured one week after the procedure using the same scales (NRS and CFS). The investigators aim to recruit 188 children.

Discussion: The investigators believe that results of this study will allow to improve pain, stress and anxiety management practices in this orthopedic clinic by showing that non-pharmacological interventions can be done, at very low cost, to improve the experience of the child undergoing these painful procedures through an innovative and more humanistic approach.

Detailed description: BACKGROUND

In children, many fractures treated surgically will be stabilized percutaneously with Kirschner wires and some will require sutures to help the surgical wound to heal. When the fracture is adequately healed, the percutaneous wires and/or the sutures are generally removed in the outpatient clinic. These procedures represent a potential source of pain, stress and anxiety for the patient, as well as for the parents and the caregivers.

A study looked at different types of analgesia during percutaneous pin removal comparing Acetaminophen, Ibuprofen and placebo but no clinically nor statistically significant difference was found among the three groups. Another study compared topical liposomal lidocaine to a placebo but found no statistically significant difference in postprocedure pain scores between groups. On the other hand, administration of narcotics or procedural sedation for pin removal procedure probably exceeds the real needs for the majority of patients. Adding the fact that the administration of narcotics or procedural sedation requires monitoring post administration, those options lengthen visit time, reduce significantly the efficiency in an outpatient clinic setting and are not recommended for routine administration.

In contrast, there seems to be some emerging evidence about distraction methods such as distraction techniques facilitated by a hospital play specialist for pin removal procedures. Distraction use for children in orthopedic outpatient clinics has been reported anecdotally in some literature but, to our knowledge, has never been formally assessed in a randomised controlled trial. Exploring non-pharmacological interventions, including distraction, could be a promising venue for pain management in this population as they are simple, practical, easily implementable and usually without side effects.

Virtual Reality (VR) is a distraction method that allows the user to interact with an immersive environment generated by a computer stimulating different senses. A review of studies on VR, mostly conducted with adult burn patients, showed a 35 to 50% reduction in procedural pain while using VR. Its positive effect has also been reported on anxiety and general distress during painful medical procedures in children and in adults such as venipuncture, wound care, chemotherapy, dental procedures, etc. A recent randomized-controlled trial comparing VR and standard distraction in children undergoing blood drawn procedures, demonstrated a significant positive effect of VR on pain and anxiety reduction as well as patients', caregivers' and phlebotomist's satisfaction. The authors also concluded that VR was more effective for children with higher anxiety sensitivity, adding another plus value to this new technology in children's care.

There is evidence to suggest that reducing procedural pain and distress in the short-term, will have long lasting effects on children's pain and health trajectories in the long-term. The effect of pain on a developing child does not end after painful procedures end; how children remember these experiences can have long lasting effects. Children who recall pain in negatively-biased ways experience more pain and distress at future pain experiences and are at risk for developing persistent pain problems and fears and avoidance of medical care. Importantly, children (and parents) who are more anxious and distressed prior to painful medical procedures, and who experience higher pain during medical procedures, are the very children who develop these negatively biased recalls. Therefore, we will also examine the effect of VR distraction, a more immersive intervention, on children's later recall of pain. This is innovative as we did not find any other studies using VR and collecting data on pain and anxiety recalls in children following painful medical procedures. Further, we will compare salivary Alpha-Amylase levels between groups, which is a reliable and valid surrogate marker of stress that increases in response to physical and psychological stressful conditions such as experience of medical procedures.

Considering the lack of optimal pain, stress and anxiety management during pin removal and/or removal or sutures, and the positive effect of VR for painful procedures, combining VR to pin/sutures removal procedures may show promising results. To our knowledge, no other studies have tested the effect of VR distraction via Oculus Quest® for procedural pain management in children undergoing painful orthopedic procedures such as percutaneous pins removal and removal of sutures.

AIM \& STUDY OBJECTIVES

Primary objective: To determine if VR distraction provides better pain relief during percutaneous pin removal procedures and/or removal of sutures, than passive distraction, in children from 7 to 21 years old.

Secondary Objectives:

1. To determine if VR distraction provides better anxiety and stress relief in children during percutaneous pin removal procedures and/or removal of sutures than passive distraction.
2. To determine if children receiving VR distraction will remember less pain and anxiety than children receiving passive distraction during the percutaneous pin removal procedure and/or removal of sutures.
3. To compare the occurrence of side effects between VR distraction and passive distraction groups.
4. To compare healthcare professionals' satisfaction levels between VR distraction and passive distraction.
5. To compare children and parents' satisfaction levels between VR distraction and passive distraction.
6. To compare requirement for rescue analgesia between VR distraction and passive distraction.
7. To compare mean levels of physiological stress between groups (Levels of salivary Alpha-Amylase - Surrogate marker of stress)

METHODS

Design: Multi-center randomized controlled trial using a parallel design with two groups: a) experimental group (virtual reality), b) active comparator (videogame on an iPad®).

Sample and Setting: Recruitment will be done through convenience sampling at the orthopedic outpatient day clinic at CHU Ste-Justine, and at the Shriners Hospital for Children and the Montreal Children's Hospital.

Measures and outcomes: Timepoints. Data will be collected by the research assistant at the following study times: before the procedure to establish baseline (T0), immediately after the procedure (T1), and one week after the procedure (T2).

Sample Size: Group sample sizes of 94 and 94 (188 in total) are necessary to achieve 80% power to reject the null hypothesis of equal means when the population mean difference for pain is 1.5 with a standard deviation for both groups of 3.3 and a significance level (alpha) of 2.5% using a two-sided t-test. Group sample sizes of 67 and 67 (134 in total) are necessary to achieve 80% power to reject the null hypothesis of equal means when the population mean difference for anxiety is 0.7 with a standard deviation for both groups of 1.3 and a significance level (alpha) of 2.5% using a two- sided t-test. Based on our pilot's study data, there were no attrition. No interim analysis will be conducted.

Data analysis plan: Descriptive statistics will be used to present sociodemographic and clinical data as well as parents, children and healthcare professionals' levels of satisfaction. Primary analyses: An ANCOVA adjusted for centers and baseline (T0) pain score measurement/anxiety score measurement will be used to assess the mean difference in pain scores on the NRS scale/the mean difference in anxiety scores on the CFS, between the experimental and the control groups at T1. Analyses will be carried out according to the intention-to-treat principle, with a significance level (α) of 0.025. Secondary analyses: Secondary analyses using ANCOVA adjusted for centers and pain score measurement/anxiety score measurement at T1 will be used to assess the mean difference in pain memories/anxiety memory between the experimental and the control groups at T2. An ANOVA adjusted for centers will be used to assess mean differences in children-reported pain on the GRS between the experimental and the control groups at T1. Correlations will be calculated to compare stress level between groups. Cochran-Mantel-Haenszel tests will be conducted to compare dichotomous variables including the occurrence of side effects, use of rescue analgesia, and use of other non-pharmacological interventions in each group.

Eligibility criteria: Inclusion Criteria:

* Requiring a percutaneous pins and/or sutures removal procedure,
* Accompanied by a consenting parent or legal guardian who can understand, read and write either French or English.

Exclusion Criteria:

* Having a diagnosed cognitive impairment preventing them from interacting with the games or answering questions related to pain, anxiety, and pain memory,
* Have a diagnosis of epilepsy or any other condition precluding them from playing a virtual reality game,
* Cannot be in a sitting or semi-upright sitting position (Fowler's position) during the procedure as the game in the virtual reality group requires an angle of at least 45 degrees for head-tracking.

Primary outcomes:
measure: Pain intensity
timeFrame: T1, immediately after the procedure.
measure: Anxiety level
timeFrame: T0, before the procedure (baseline); T1, immediately after the procedure.
Secondary outcomes:
measure: Presence in the game
timeFrame: T1, immediately after the procedure
measure: Stress
timeFrame: T0, before the procedure (baseline); T1, immediately after the procedure.
measure: Parents' and children's satisfaction levels
timeFrame: T1, immediately after the procedure
measure: Healthcare professionals' satisfaction level
timeFrame: An average of one year after the beginning of the study (mid-recruitement)
measure: Analgesic requirement
timeFrame: T1, immediately after the procedure
measure: Co-interventions
timeFrame: T1, immediately after the procedure
measure: Side effects
timeFrame: T1, immediately after the procedure.
measure: Children's memory of pain
timeFrame: T2, one week after the procedure
measure: Children's memory of anxiety
timeFrame: T2, one week after the procedure
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: St. Justine's Hospital
state: Quebec
city: Montréal
country: Canada
facility: Shriners Hospitals for Children
state: Quebec
city: Montréal
country: Canada
facility: Montreal Children's Hospital of the MUHC
state: Quebec
Study officials:
affiliation: St. Justine's Hospital
name: Sylvie Le May, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Le May S, Tsimicalis A, Noel M, Rainville P, Khadra C, Ballard A, Guingo E, Cotes-Turpin C, Addab S, Chougui K, Francoeur M, Hung N, Bernstein M, Bouchard S, Parent S, Hupin Debeurme M. Immersive virtual reality vs. non-immersive distraction for pain management of children during bone pins and sutures removal: A randomized clinical trial protocol. J Adv Nurs. 2021 Jan;77(1):439-447. doi: 10.1111/jan.14607. Epub 2020 Oct 24.