CClinicalTrials.gg
CompletedNCT03421795Updated May 7, 2019

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

An interventional study of Let's Talk About Pain Training and Family Centered Care Training in Pain, sponsored by University of Guelph. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-07.

Sponsored by University of Guelph · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
178
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Pain

Keywords

  • pain assessment/management
  • developmental disabilities
  • children
  • education
  • respite workers
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • n/a
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
178 participants (actual)

Study arms

  • 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.

    Other: Let's Talk About Pain Training

  • 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) .

    Other: Family Centered Care Training

Interventions

  • OtherLet's Talk About Pain Training

    See arm/group descriptions.

  • OtherFamily Centered Care Training

    See arm/group descriptions.

05

What researchers measure

Primary outcomes

  1. Within intervention group change from baseline in scores on Questionnaire for Understanding Pain in Individuals with Intellectual and Developmental Disabilities - Revised

    Pain-related knowledge assessment

    Time frame: Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)

  2. Within intervention group change (i.e., maintenance) from post in scores on Questionnaire for Understanding Pain in Individuals with Intellectual and Developmental Disabilities - Revised

    Pain-related knowledge assessment

    Time frame: Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)

  3. Between group difference in scores on Questionnaire for Understanding Pain in Individuals with Intellectual and Developmental Disabilities - Revised

    Pain-related knowledge assessment

    Time frame: Post (within 30 minutes after completion of training)

  4. Between group difference in scores on Questionnaire for Understanding Pain in Individuals with Intellectual and Developmental Disabilities - Revised

    Pain-related knowledge assessment

    Time frame: Follow-Up (approximately one month after training)

Secondary outcomes

  1. Between group difference in ratings of the feasibility of pain assessment

    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.

    Time frame: Post (within 30 minutes after completion of training)

  2. Between group difference in ratings of the feasibility of pain assessment

    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.

    Time frame: Follow-Up (approximately one month after training)

  3. Between group difference ratings of the feasibility of pain management

    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.

    Time frame: Post (within 30 minutes after completion of training)

  4. Between group difference ratings of the feasibility of pain management

    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.

    Time frame: Follow-Up (approximately one month after training)

  5. Between group difference ratings of perceived confidence in pain assessment abilities

    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.

    Time frame: Post (within 30 minutes after completion of training)

  6. Between group difference ratings of perceived confidence in pain assessment abilities

    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.

    Time frame: Follow-Up (approximately one month after training)

  7. Between group difference ratings of perceived confidence in pain management abilities

    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.

    Time frame: Post (within 30 minutes after completion of training)

  8. Between group difference ratings of perceived confidence in pain management abilities

    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.

    Time frame: Follow-Up (approximately one month after training)

  9. Between group difference ratings of perceived skill in pain assessment

    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.

    Time frame: Post (within 30 minutes after completion of training)

  10. Between group difference ratings of perceived skill in pain assessment

    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.

    Time frame: Follow-Up (approximately one month after training)

  11. Between group difference ratings of perceived skill in pain management

    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.

    Time frame: Post (within 30 minutes after completion of training)

  12. Between group difference ratings of perceived skill in pain management

    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.

    Time frame: Follow-Up (approximately one month after training)

  13. Within intervention group change from baseline in ratings of the feasibility of pain assessment

    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.

    Time frame: Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)

  14. Within intervention group change from baseline in ratings of the feasibility of pain management

    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.

    Time frame: Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)

  15. Within intervention group change from baseline in ratings of perceived confidence in pain assessment

    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.

    Time frame: Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)

  16. Within intervention group change from baseline in ratings of perceived confidence in pain management

    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.

    Time frame: Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)

  17. Within intervention group change from baseline in ratings of perceived skill in pain assessment

    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.

    Time frame: Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)

  18. Within intervention group change from baseline in ratings of perceived skill in pain management

    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.

    Time frame: Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)

  19. Within intervention group change (i.e., maintenance) from post in ratings of the feasibility of pain assessment

    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.

    Time frame: Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)

  20. Within intervention group change (i.e., maintenance) from post in ratings of the feasibility of pain management

    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.

    Time frame: Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)

  21. Within intervention group change (i.e., maintenance) from post in ratings of perceived confidence in pain assessment

    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.

    Time frame: Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)

  22. Within intervention group change (i.e., maintenance) from post in ratings of perceived confidence in pain management

    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.

    Time frame: Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)

  23. Within intervention group change (i.e., maintenance) from post in ratings of perceived skill in pain assessment

    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.

    Time frame: Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)

  24. Within intervention group change (i.e., maintenance) from post in ratings of perceived skill in pain management

    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.

    Time frame: Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)

Other outcomes

  1. Between group difference in use of evidence-based pain assessment and management strategies as indicated on a researcher-generated questionnaire and in focus groups

    Assessment of use of evidence-based pain assessment and management strategies (researcher generated questionnaire with open-ended responses and focus groups)

    Time frame: Follow-Up (approximately one month after training)

  2. Within intervention group change from baseline in use of evidence-based pain assessment and management strategies as indicated on a researcher-generated questionnaire

    Assessment of use of evidence-based pain assessment and management strategies (researcher generated questionnaire)

    Time frame: Baseline (within 30 minutes prior to start of training), Follow-Up (approximately one month after training)

  3. Within intervention group descriptive ratings of training

    Assessment of training program endorsement

    Time frame: Post (within 30 minutes after completion of training)

06

Study locations

1 site
  • University of Guelph
    Guelph, Ontario N1G2W1, Canada
07

References and documents

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. PubMed 19963417 ↗
  • 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. PubMed 23972870 ↗
  • 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. PubMed 22497741 ↗
  • 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. PubMed 28208103 ↗
  • 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. PubMed 28877138 ↗
  • 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. PubMed 14600533 ↗
  • 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. PubMed 35547857 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03421795
Lead sponsor
University of Guelph
Collaborators
Canadian Institutes of Health Research (CIHR), Society of Pediatric Psychology, Western University
Responsible party
Meghan McMurtry (Associate Professor, University of Guelph) — Principal investigator
First posted
Feb 5, 2018
Start date
May 8, 2017
Primary completion
Jul 3, 2018
Completion
Aug 2, 2018
Last update
May 7, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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