PainNCT03421795
Effectiveness of a Pain Assessment and Management Program for Respite Workers Supporting Children With Disabilities
A study testing Let's Talk About Pain Training and Family Centered Care Training in people with Pain, run by University of Guelph at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Let's Talk About Pain Training and Family Centered Care Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 178 participants
- Where
- 1 siteCanada
- Study dates
- 8 May 2017to 2 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Pain
- Being tested
- Let's Talk About Pain Training, Family Centered Care Training
- Keywords
- pain assessment/management, developmental disabilities, children, education, respite workers
- Medical subject headings
- Pain, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Let's Talk About Pain TrainingOther
See arm/group descriptions.
Family Centered Care TrainingOther
See arm/group descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Let's Talk About Pain Training | Experimental | 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. Receives: Other: Let's Talk About Pain Training |
| Family Centered Care Training | Sham comparator | 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) . Receives: Other: Family Centered Care Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Pain-related knowledge assessment
Measured: 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
Pain-related knowledge assessment
Measured: 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
Pain-related knowledge assessment
Measured: Follow-Up (approximately one month after training)
Secondary outcomes (24)
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.
Measured: Post (within 30 minutes after completion of training)
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.
Measured: Follow-Up (approximately one month after training)
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.
Measured: Post (within 30 minutes after completion of training)
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.
Measured: Follow-Up (approximately one month after training)
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.
Measured: Post (within 30 minutes after completion of training)
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.
Measured: Follow-Up (approximately one month after training)
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.
Measured: Post (within 30 minutes after completion of training)
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.
Measured: Follow-Up (approximately one month after training)
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.
Measured: Post (within 30 minutes after completion of training)
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.
Measured: Follow-Up (approximately one month after training)
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.
Measured: Post (within 30 minutes after completion of training)
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.
Measured: Follow-Up (approximately one month after training)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start8 May 2017
- Primary completion3 Jul 2018
- Study completion2 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multi-centre clustered parallel RCT with an intervention group (pain training) and control group (control training about family centered care, with an option to receive pain training after follow-up).
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Society of Pediatric Psychology, Western University
- Responsible party
- Principal investigator, Meghan McMurtry, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421795
- Sponsor's protocol ID
- REB16-12-696
- Status last verified
- May 2019
- First submitted
- 12 Dec 2017
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 19963417Twycross 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 23972870Chen-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 22497741Genik 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 28208103Genik 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 28877138Breau 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 14600533Genik 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
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03421795
- Acronym / sponsor ID
- REB16-12-696
- Conditions
- Pain
- Keywords
- pain assessment/management, developmental disabilities, children, education, respite workers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Society of Pediatric Psychology, Western University
- Study start
- 8 May 2017 (actual)
- Primary completion
- 3 Jul 2018 (actual)
- Study completion
- 2 Aug 2018 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a multi-centre clustered parallel RCT with an intervention group (pain training) and control group (control training about family centered care, with an option to receive pain training after follow-up).
| Arm | Type | Receives |
|---|---|---|
| Let's Talk About Pain Training | Experimental | Other: Let's Talk About Pain TrainingParticipants 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. |
| Family Centered Care Training | Sham comparator | Other: Family Centered Care TrainingParticipants 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) . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- n/a
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Let's Talk About Pain TrainingSee arm/group descriptions. | Other | Let's Talk About Pain Training |
| Family Centered Care TrainingSee arm/group descriptions. | Other | Family Centered Care Training |
Primary outcome
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
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
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
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
24 secondary outcomes
Between group difference in ratings of the feasibility of pain assessment
Time frame: 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)
Between group difference ratings of the feasibility of pain management
Time frame: 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)
Between group difference ratings of perceived confidence in pain assessment abilities
Time frame: 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)
Between group difference ratings of perceived confidence in pain management abilities
Time frame: 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)
Between group difference ratings of perceived skill in pain assessment
Time frame: 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)
Between group difference ratings of perceived skill in pain management
Time frame: 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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Background: PubMed 19963417Dubois 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.
- Background: PubMed 23972870Twycross 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.
- Background: PubMed 22497741Chen-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.
- Background: PubMed 28208103Genik 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.
- Background: PubMed 28877138Genik 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.
- Background: PubMed 14600533Breau 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.
- Derived from this study: PubMed 35547857Genik 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Let's Talk About Pain Training and Family Centered Care Training in people with Pain, run by University of Guelph at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03421795, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2019.