Effectiveness of a Pain Assessment and Management Program for Respite Workers Supporting Children With Disabilities
Let's Talk About Pain: A Randomized Controlled Trial Testing the Effectiveness of a Pain Assessment and Management Training Program for Respite Workers Supporting Children With Intellectual and Developmental Disabilities
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Background Information: Everyday pain is common in children with intellectual/developmental disabilities (I/DD). Inadequately managed pain in this population is a common problem, and this is likely due to these children's inability to communicate pain effectively. Unfortunately, many of these children are unable to accurately self-report or effectively communicate the pain experience. Thus, caregivers are often responsible for assessing their pain. Research has focused on professionals and parents, but it is also common for children with I/DD to receive care from others including respite workers. The investigators recently found a difference between pain beliefs held by respite workers and individuals with little to no experience with this population. Specifically, respite workers believed that a significantly larger percentage of children with severe I/DD sensed less pain than typically developing children. This is contrary to research suggesting that children with I/DD have similar pain perception but communicate it differently (e.g., through idiosyncratic behaviours). Thus, it is possible that respite workers miss critical cues when children with I/DD are in pain. As such, the investigators have developed and successfully piloted a pain training program targeted to respite workers who support children with I/DD. This program demonstrated initial success in improving respite workers' pain-related knowledge, as well as their perceptions of the feasibility of and their own confidence and skill in pain assessment and management with this population of children.
Within a randomized control trial, the objectives of this study are to further test the effectiveness of the Let's Talk About Pain respite worker training program on respite workers' (a) pain-related knowledge, (b) self-rated perceptions of the feasibility of and their own confidence and skill in pain assessment and management, and (c) use of pain assessment and management strategies specific to children with I/DD in respite settings. Participants will complete questionnaires immediately before and after provision of a pain training (or control training). Approximately one month after the training, participants will complete these questionnaires for a third time and participate in a focus group regarding their pain assessment and management strategy use.
The long term objectives of this line of research are to: 1) increase pain assessment and management abilities of respite workers, and, consequently, 2) decrease levels of suffering and ill-managed pain in children with I/DD.
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Ontario
-
Guelph, Ontario, Canada, N1G2W1
- University of Guelph
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Over the age of 18
- Proficient in the English language
- Active respite worker who provides respite care to children (age 0 - 18) with developmental disabilities
Exclusion Criteria:
- n/a
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Let's Talk About Pain Training
Participants complete pre-, post- and follow-up measures, and receive a pain training program.
The pain assessment and management training will be based on a training previously developed and piloted by Genik et al. (2017).
The training will be facilitated by the same researcher (L.G.) throughout the study.
|
See arm/group descriptions.
|
|
Sham Comparator: Family Centered Care Training
Participants complete all of the same measures as those in the intervention, but receive a training about family centered care.
This training will be facilitated by Andrea Cross (PhD Candidate) from CanChild and will be related to the F-words of childhood disability (function, family, fitness, fun, friends, future; Rosenbaum & Gorter, 2012) .
|
See arm/group descriptions.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Within intervention group change from baseline in scores on Questionnaire for Understanding Pain in Individuals with Intellectual and Developmental Disabilities - Revised
Time Frame: Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)
|
Pain-related knowledge assessment
|
Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)
|
|
Within intervention group change (i.e., maintenance) from post in scores on Questionnaire for Understanding Pain in Individuals with Intellectual and Developmental Disabilities - Revised
Time Frame: Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)
|
Pain-related knowledge assessment
|
Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)
|
|
Between group difference in scores on Questionnaire for Understanding Pain in Individuals with Intellectual and Developmental Disabilities - Revised
Time Frame: Post (within 30 minutes after completion of training)
|
Pain-related knowledge assessment
|
Post (within 30 minutes after completion of training)
|
|
Between group difference in scores on Questionnaire for Understanding Pain in Individuals with Intellectual and Developmental Disabilities - Revised
Time Frame: Follow-Up (approximately one month after training)
|
Pain-related knowledge assessment
|
Follow-Up (approximately one month after training)
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Between group difference in ratings of the feasibility of pain assessment
Time Frame: Post (within 30 minutes after completion of training)
|
Researcher generated scale measuring participants' perceptions of the feasibility of pain assessment; 0 (Not feasible at all) - 10 (highly/extremely feasible) Likert Scale.
Higher scores are better.
|
Post (within 30 minutes after completion of training)
|
|
Between group difference in ratings of the feasibility of pain assessment
Time Frame: Follow-Up (approximately one month after training)
|
Researcher generated scale measuring participants' perceptions of the feasibility of pain assessment; 0 (Not feasible at all) - 10 (highly/extremely feasible) Likert Scale.
Higher scores are better.
|
Follow-Up (approximately one month after training)
|
|
Between group difference ratings of the feasibility of pain management
Time Frame: Post (within 30 minutes after completion of training)
|
Researcher generated scale measuring participants' perceptions of the feasibility of pain management; 0 (Not feasible at all) - 10 (highly/extremely feasible) Likert Scale.
Higher scores are better.
|
Post (within 30 minutes after completion of training)
|
|
Between group difference ratings of the feasibility of pain management
Time Frame: Follow-Up (approximately one month after training)
|
Researcher generated scale measuring participants' perceptions of the feasibility of pain management; 0 (Not feasible at all) - 10 (highly/extremely feasible) Likert Scale.
Higher scores are better.
|
Follow-Up (approximately one month after training)
|
|
Between group difference ratings of perceived confidence in pain assessment abilities
Time Frame: Post (within 30 minutes after completion of training)
|
Researcher generated scale measuring participants' perceptions of their own confidence in their pain assessment abilities; 0 (Not confident at all) - 10 (highly/extremely confident) Likert Scale.
Higher scores are better.
|
Post (within 30 minutes after completion of training)
|
|
Between group difference ratings of perceived confidence in pain assessment abilities
Time Frame: Follow-Up (approximately one month after training)
|
Researcher generated scale measuring participants' perceptions of their own confidence in their pain assessment abilities; 0 (Not confident at all) - 10 (highly/extremely confident) Likert Scale.
Higher scores are better.
|
Follow-Up (approximately one month after training)
|
|
Between group difference ratings of perceived confidence in pain management abilities
Time Frame: Post (within 30 minutes after completion of training)
|
Researcher generated scale measuring participants' perceptions of their own confidence in their pain management abilities; 0 (Not confident at all) - 10 (highly/extremely confident) Likert Scale.
Higher scores are better.
|
Post (within 30 minutes after completion of training)
|
|
Between group difference ratings of perceived confidence in pain management abilities
Time Frame: Follow-Up (approximately one month after training)
|
Researcher generated scale measuring participants' perceptions of their own confidence in their pain management abilities; 0 (Not confident at all) - 10 (highly/extremely confident) Likert Scale.
Higher scores are better.
|
Follow-Up (approximately one month after training)
|
|
Between group difference ratings of perceived skill in pain assessment
Time Frame: Post (within 30 minutes after completion of training)
|
Researcher generated scale measuring participants' perceptions of their own skill in pain assessment; 0 (Not skilled at all) - 10 (highly/extremely skilled) Likert Scale.
Higher scores are better.
|
Post (within 30 minutes after completion of training)
|
|
Between group difference ratings of perceived skill in pain assessment
Time Frame: Follow-Up (approximately one month after training)
|
Researcher generated scale measuring participants' perceptions of their own skill in pain assessment; 0 (Not skilled at all) - 10 (highly/extremely skilled) Likert Scale.
Higher scores are better.
|
Follow-Up (approximately one month after training)
|
|
Between group difference ratings of perceived skill in pain management
Time Frame: Post (within 30 minutes after completion of training)
|
Researcher generated scale measuring participants' perceptions of their own skill in pain management; 0 (Not skilled at all) - 10 (highly/extremely skilled) Likert Scale.
Higher scores are better.
|
Post (within 30 minutes after completion of training)
|
|
Between group difference ratings of perceived skill in pain management
Time Frame: Follow-Up (approximately one month after training)
|
Researcher generated scale measuring participants' perceptions of their own skill in pain management; 0 (Not skilled at all) - 10 (highly/extremely skilled) Likert Scale.
Higher scores are better.
|
Follow-Up (approximately one month after training)
|
|
Within intervention group change from baseline in ratings of the feasibility of pain assessment
Time Frame: Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)
|
Researcher generated scale measuring participants' perceptions of the feasibility of pain assessment; 0 (Not feasible at all) - 10 (highly/extremely feasible) Likert Scale.
Higher scores are better.
|
Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)
|
|
Within intervention group change from baseline in ratings of the feasibility of pain management
Time Frame: Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)
|
Researcher generated scale measuring participants' perceptions of the feasibility of pain management; 0 (Not feasible at all) - 10 (highly/extremely feasible) Likert Scale.
Higher scores are better.
|
Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)
|
|
Within intervention group change from baseline in ratings of perceived confidence in pain assessment
Time Frame: Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)
|
Researcher generated scale measuring participants' perceptions of their own confidence in their pain assessment abilities; 0 (Not confident at all) - 10 (highly/extremely confident) Likert Scale.
Higher scores are better.
|
Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)
|
|
Within intervention group change from baseline in ratings of perceived confidence in pain management
Time Frame: Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)
|
Researcher generated scale measuring participants' perceptions of their own confidence in their pain management abilities; 0 (Not confident at all) - 10 (highly/extremely confident) Likert Scale.
Higher scores are better.
|
Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)
|
|
Within intervention group change from baseline in ratings of perceived skill in pain assessment
Time Frame: Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)
|
Researcher generated scale measuring participants' perceptions of their own skill in pain assessment; 0 (Not skilled at all) - 10 (highly/extremely skilled) Likert Scale.
Higher scores are better.
|
Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)
|
|
Within intervention group change from baseline in ratings of perceived skill in pain management
Time Frame: Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)
|
Researcher generated scale measuring participants' perceptions of their own skill in pain management; 0 (Not skilled at all) - 10 (highly/extremely skilled) Likert Scale.
Higher scores are better.
|
Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)
|
|
Within intervention group change (i.e., maintenance) from post in ratings of the feasibility of pain assessment
Time Frame: Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)
|
Researcher generated scale measuring participants' perceptions of the feasibility of pain assessment; 0 (Not feasible at all) - 10 (highly/extremely feasible) Likert Scale.
Higher scores are better.
|
Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)
|
|
Within intervention group change (i.e., maintenance) from post in ratings of the feasibility of pain management
Time Frame: Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)
|
Researcher generated scale measuring participants' perceptions of the feasibility of pain management; 0 (Not feasible at all) - 10 (highly/extremely feasible) Likert Scale.
Higher scores are better.
|
Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)
|
|
Within intervention group change (i.e., maintenance) from post in ratings of perceived confidence in pain assessment
Time Frame: Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)
|
Researcher generated scale measuring participants' perceptions of their own confidence in their pain assessment abilities; 0 (Not confident at all) - 10 (highly/extremely confident) Likert Scale.
Higher scores are better.
|
Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)
|
|
Within intervention group change (i.e., maintenance) from post in ratings of perceived confidence in pain management
Time Frame: Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)
|
Researcher generated scale measuring participants' perceptions of their own confidence in their pain management abilities; 0 (Not confident at all) - 10 (highly/extremely confident) Likert Scale.
Higher scores are better.
|
Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)
|
|
Within intervention group change (i.e., maintenance) from post in ratings of perceived skill in pain assessment
Time Frame: Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)
|
Researcher generated scale measuring participants' perceptions of their own skill in pain assessment; 0 (Not skilled at all) - 10 (highly/extremely skilled) Likert Scale.
Higher scores are better.
|
Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)
|
|
Within intervention group change (i.e., maintenance) from post in ratings of perceived skill in pain management
Time Frame: Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)
|
Researcher generated scale measuring participants' perceptions of their own skill in pain management; 0 (Not skilled at all) - 10 (highly/extremely skilled) Likert Scale.
Higher scores are better.
|
Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Between group difference in use of evidence-based pain assessment and management strategies as indicated on a researcher-generated questionnaire and in focus groups
Time Frame: Follow-Up (approximately one month after training)
|
Assessment of use of evidence-based pain assessment and management strategies (researcher generated questionnaire with open-ended responses and focus groups)
|
Follow-Up (approximately one month after training)
|
|
Within intervention group change from baseline in use of evidence-based pain assessment and management strategies as indicated on a researcher-generated questionnaire
Time Frame: Baseline (within 30 minutes prior to start of training), Follow-Up (approximately one month after training)
|
Assessment of use of evidence-based pain assessment and management strategies (researcher generated questionnaire)
|
Baseline (within 30 minutes prior to start of training), Follow-Up (approximately one month after training)
|
|
Within intervention group descriptive ratings of training
Time Frame: Post (within 30 minutes after completion of training)
|
Assessment of training program endorsement
|
Post (within 30 minutes after completion of training)
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Publications and helpful links
General Publications
- Dubois A, Capdevila X, Bringuier S, Pry R. Pain expression in children with an intellectual disability. Eur J Pain. 2010 Jul;14(6):654-60. doi: 10.1016/j.ejpain.2009.10.013. Epub 2009 Dec 5.
- Twycross A, Williams A. Establishing the validity and reliability of a pediatric pain knowledge and attitudes questionnaire. Pain Manag Nurs. 2013 Sep;14(3):e47-53. doi: 10.1016/j.pmn.2011.03.001. Epub 2011 Apr 17.
- Chen-Lim ML, Zarnowsky C, Green R, Shaffer S, Holtzer B, Ely E. Optimizing the assessment of pain in children who are cognitively impaired through the quality improvement process. J Pediatr Nurs. 2012 Dec;27(6):750-9. doi: 10.1016/j.pedn.2012.03.023. Epub 2012 Apr 10.
- Genik LM, McMurtry CM, Breau LM. Caring for children with intellectual disabilities part 1: Experience with the population, pain-related beliefs, and care decisions. Res Dev Disabil. 2017 Mar;62:197-208. doi: 10.1016/j.ridd.2017.01.020. Epub 2017 Feb 14.
- Genik LM, McMurtry CM, Breau LM, Lewis SP, Freedman-Kalchman T. Pain in Children With Developmental Disabilities: Development and Preliminary Effectiveness of a Pain Training Workshop for Respite Workers. Clin J Pain. 2018 May;34(5):428-437. doi: 10.1097/AJP.0000000000000554.
- Breau LM, MacLaren J, McGrath PJ, Camfield CS, Finley GA. Caregivers' beliefs regarding pain in children with cognitive impairment: relation between pain sensation and reaction increases with severity of impairment. Clin J Pain. 2003 Nov-Dec;19(6):335-44. doi: 10.1097/00002508-200311000-00001.
- Genik LM, McMurtry CM, Barata PC, Barney CC, Lewis SP. Study protocol for a multi-centre parallel two-group randomized controlled trial evaluating the effectiveness and impact of a pain assessment and management program for respite workers supporting children with disabilities. Paediatr Neonatal Pain. 2020 Apr 26;2(1):7-13. doi: 10.1002/pne2.12014. eCollection 2020 Mar.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- REB16-12-696
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
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