Effectiveness of a Pain Assessment and Management Program for Respite Workers Supporting Children With Disabilities

May 5, 2019 updated by: Meghan McMurtry, University of Guelph

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

This study investigates the impact of pain training delivery for respite care providers who support children with developmental disabilities on (a) pain assessment and management-related knowledge, (b) participant self-rated perceptions of the feasibility, confidence and skill in pain assessment and management, and (c) strategy use. Half of the participants will receive the pain training, while half will receive the training about family-centered care, and be offered the pain training after completion of the follow-up.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

178

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Guelph, Ontario, Canada, N1G2W1
        • University of Guelph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / 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

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

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

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

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2017

Primary Completion (Actual)

July 3, 2018

Study Completion (Actual)

August 2, 2018

Study Registration Dates

First Submitted

December 12, 2017

First Submitted That Met QC Criteria

January 29, 2018

First Posted (Actual)

February 5, 2018

Study Record Updates

Last Update Posted (Actual)

May 7, 2019

Last Update Submitted That Met QC Criteria

May 5, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • REB16-12-696

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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