Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03680625 |
| Other study ID # |
2019-2030 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 14, 2019 |
| Est. completion date |
October 25, 2022 |
Study information
| Verified date |
October 2022 |
| Source |
St. Justine's Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
