Chronic PainNCT04081454
Comfortability Workshop
An observational study of Chronic Pain, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The Comfort Ability is a fun and interactive one-day (6 hour) program to help children and their parents or caregivers learn how to better manage chronic pain. The program introduces cognitive-behavioral and bio-behavioral pain management strategies to emphasize the mind-body connection and offers non-invasive and… Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Workshop and Education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2021to 18 Dec 2023
- Phase
- Observational
- 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 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 11 - 17 with chronic pain and their parents or caregivers
Who may be able to join
- 11 years to 17 years
- Ability to provide informed consent
Who cannot join
- Cognitive Delay that may impact completion of questionnaires and involvement of youth group at workshop.
- Families without access to internet to complete 1 week, 1 month and 3 month follow up questionnaires.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine/Barnes Jewish Hospital
St Louis, Missouri, 63110
About this study
Official title: The Comfort Ability Workshop: Improving Pain Treatment for Children and Their Families
The Comfort Ability is a fun and interactive one-day (6 hour) program to help children and their parents or caregivers learn how to better manage chronic pain. The program introduces cognitive-behavioral and bio-behavioral pain management strategies to emphasize the mind-body connection and offers non-invasive and non-pharmaceutical strategies for improved pain management. Youth ages 11-18 with chronic or recurrent pain are eligible to sign up for Comfort Ability.
Read the detailed description
This 1-day, manualized clinical intervention includes a parent group and an adolescent group that run simultaneously, but separately. This program will be offered 4 times per calendar year. The program is 6-hours long and was run at an urban, Midwest children's hospital on a weekend day to maximize accessibility for families. Each group will include between 8 and 12 adolescents (ages 11-17 years) and 15-21 parents. The groups will be staffed by two PhD-level psychologists (one for the parent and one for the adolescent group), a psychology postdoctoral fellow, and nurse practitioner, one or two trained study assistants (e.g., psychology interns, nurse coordinator) who provide support, but not intervention content.
The adolescent program includes motivational interviewing, psychoeducation, and structured activities that emphasize the link between pain, negative cognitions (i.e., catastrophizing), avoidance behaviors, and mood. About one third of the day is devoted to in vivo practice of relaxation-based skills including diaphragmatic breathing, guided imagery, pain-reduction visualization, and biofeedback. Additionally, adolescents participate in several hands-on activities designed to enhance mind-body regulation including mindfulness practice (eating mindfully), art therapy, and aromatherapy. Adolescents complete interactive workbooks throughout the program; at the end of the day, each adolescent works one-on-one with staff to create a written and personalized pain management plan emphasizing the adaptive coping strategies each adolescent preferred during the day. Adolescents were additionally provided with a pain management tool kit inclusive of recorded relaxation exercises, a biofeedback card, and other small tools to enhance their pain management regimen.
The parent program includes psychoeducation regarding pain in the context of adolescent development, didactic and vignette-based practice of an adaptive parent communication response style (i.e., reflective listening), and concrete tools for setting up behavior plans to scaffold an adolescent's return to function for school, sleep, daily activities, and exercise. All parents are provided with a take-home workbook inclusive of neuroscience and psychoeducational materials as well as a list of resources to further solidify the information they learned.
In addition there will be peer support for parents and adolescents in this program. During the 1 day intervention families and youth will be encouraged to share discussions regarding their health journeys. A guest speaker will be invited to both groups sharing their experiences and journey of utilizing psychologically based interventions to assist with reducing pain and stress and associated disability. These speakers have not received training for this portion.
- Conditions
- Chronic Pain
- Being tested
- Workshop, Education
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WorkshopBehavioural
one-day (6 hour) program to help children and their parents or caregivers learn how to better manage chronic pain
EducationBehavioural
The parent program includes psychoeducation regarding pain in the context of adolescent development, didactic and vignette-based practice of an adaptive parent communication response style (i.e., reflective listening), and concrete tools for setting up behavior plans to scaffold an adolescent's return to function for school, sleep, daily activities, and exercise. All parents are provided with a take-home workbook inclusive of neuroscience and psychoeducational materials as well as a list of resources to further solidify the information they learned.
| Study group | Role | What they receive |
|---|---|---|
| Children with chronic pain | Not described Receives: Behavioral: Workshop; Behavioral: Education | |
| Caregivers of children with chronic pain | Not described Receives: Behavioral: Workshop; Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the efficacy of this program in change of pain interference: PROMIS
Pediatric pain interference over the past 7 days on scale of 1 - 5. 1=Never, 2=Almost Never, 3=Sometimes, 4=Often, 5=Almost Always
Measured: up to 3 months after workshop
Assess the efficacy of this program in change of pain interference: Pain Self Efficacy Scal - Adolescent
Questionnaire to assess confidence with doing daily tasks when in pain. Scale of 1-5. 1=very sure, 2=pretty sure, 3=in the middle, 4=pretty unsure, 5=very unsure
Measured: up to 3 months after workshop
Assess the efficacy of this program in change of pain interference: Functional Disability Inventory
Questionnaire relating to difficulty of doing regular activities. Scale of 0 - 4. 0=no trouble, 1=a little trouble, 2=some trouble, 3=a lot of trouble, 4=impossible
Measured: up to 3 months after workshop
Assess the efficacy of this program in change of pain interference: Post-Workshop Questionnaire for Parent/Caregiver
Use of questionnaire to measure child's opinion of eductional material during workshop. Scale of 1 -5. 1=Strongly disagree, 2=disagree, 3=unsure, 4=Agree, 5=Strongly Agree
Measured: up to 3 months after workshop
Assess the efficacy of this program in change of pain interference: Pain Catastrophizing Scale
Assess thoughts and feelings when participant is in pain. Scale 0-4. 0=Not at all, 1=to a slight degree, 2=to a moderate degree, 3=to a great degree, 4=all the time
Measured: up to 3 months after workshop
Assess the efficacy of this program in change of pain interference: Pediatric Pain Screen Tool
Assess child's pain location and interference in daily life. Yes/No answers
Measured: up to 3 months after workshop
Assess the efficacy of this program in change of pain interference: Treatment History Questionnaire
Questionnaire to capture demographics, medical history, goals of treatment
Measured: up to 2 weeks before workshop
Assess the efficacy of this program in change of pain interference: Adult Responses to Children's Symptoms
Parent/Caregiver questionnaire to assess child's symptoms. Scale of 0 - 5, with 0=never and 5=often
Measured: up to 3 months after workshop
Assess the efficacy of this program in change of pain interference: Pain Self Efficacy Scale - Child
Questionnaire to assess confidence with doing daily tasks when in pain. Scale of 1-5. 1=very sure, 2=pretty sure, 3=in the middle, 4=pretty unsure, 5=very unsure
Measured: up to 3 months after workshop
Determine if the workshop increases children's pain self-efficacy and improves patients function at our institution: PROMIS
Pediatric pain interference over the past 7 days on scale of 1 - 5. 1=Never, 2=Almost Never, 3=Sometimes, 4=Often, 5=Almost Always
Measured: Up to 3 months following workshop
Determine if the workshop increases children's pain self-efficacy and improves patients function at our institution: Post-Workshop Questionnaire for Parent/Caregiver
Use of questionnaire to measure parent/caregiver's opinion of eductional material during workshop. Scale of 1 -5. 1=Strongly disagree, 2=disagree, 3=unsure, 4=Agree, 5=Strongly Agree
Measured: up to 3 months after workshop
Determine if the workshop increases children's pain self-efficacy and improves patients function at our institution: Functional Disability
Questionnaire relating to difficulty of doing regular activities. Scale of 0 - 4. 0=no trouble, 1=a little trouble, 2=some trouble, 3=a lot of trouble, 4=impossible
Measured: Up to 3 months following workshop
Determine if the workshop increases parental management strategies of their child's pain at our institution: PROMIS
Pediatric pain interference over the past 7 days on scale of 1 - 5. 1=Never, 2=Almost Never, 3=Sometimes, 4=Often, 5=Almost Always
Measured: Up to 3 months following workshop
Determine if the workshop increases parental management strategies of their child's pain at our institution: Pain Evaluation Questionnaire
Use of questionnaires to measure parental management strategies.
Measured: Up to 3 months following workshop
Determine if the workshop increases parental management strategies of their child's pain at our institution: Functional Disability
Questionnaire relating to difficulty of doing regular activities. Scale of 0 - 4. 0=no trouble, 1=a little trouble, 2=some trouble, 3=a lot of trouble, 4=impossible
Measured: Up to 3 months following workshop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start14 Aug 2021
- Primary completion18 Dec 2023
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacob AuBuchon, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081454
- Sponsor's protocol ID
- 201907083
- Status last verified
- Apr 2024
- First submitted
- 17 Aug 2019
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coakley R, Wihak T, Kossowsky J, Iversen C, Donado C. The Comfort Ability Pain Management Workshop: A Preliminary, Nonrandomized Investigation of a Brief, Cognitive, Biobehavioral, and Parent Training Intervention for Pediatric Chronic Pain. J Pediatr Psychol. 2018 Apr 1;43(3):252-265. doi: 10.1093/jpepsy/jsx112.
PubMed 29048506Perquin CW, Hazebroek-Kampschreur AA, Hunfeld JA, van Suijlekom-Smit LW, Passchier J, van der Wouden JC. Chronic pain among children and adolescents: physician consultation and medication use. Clin J Pain. 2000 Sep;16(3):229-35. doi: 10.1097/00002508-200009000-00008.
PubMed 11014396Roth-Isigkeit A, Thyen U, Raspe HH, Stoven H, Schmucker P. Reports of pain among German children and adolescents: an epidemiological study. Acta Paediatr. 2004 Feb;93(2):258-63.
PubMed 15046285
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comfort Ability Workshop: Improving Pain Treatment for Children and Their Families
- ClinicalTrials.gov ID
- NCT04081454
- Acronym / sponsor ID
- 201907083
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 14 Aug 2021 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 9 Sep 2019 (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.
The Comfort Ability is a fun and interactive one-day (6 hour) program to help children and their parents or caregivers learn how to better manage chronic pain. The program introduces cognitive-behavioral and bio-behavioral pain management strategies to emphasize the mind-body connection and offers non-invasive and non-pharmaceutical strategies for improved pain management. Youth ages 11-18 with chronic or recurrent pain are eligible to sign up for Comfort Ability.
Detailed description
This 1-day, manualized clinical intervention includes a parent group and an adolescent group that run simultaneously, but separately. This program will be offered 4 times per calendar year. The program is 6-hours long and was run at an urban, Midwest children's hospital on a weekend day to maximize accessibility for families. Each group will include between 8 and 12 adolescents (ages 11-17 years) and 15-21 parents. The groups will be staffed by two PhD-level psychologists (one for the parent and one for the adolescent group), a psychology postdoctoral fellow, and nurse practitioner, one or two trained study assistants (e.g., psychology interns, nurse coordinator) who provide support, but not intervention content.
The adolescent program includes motivational interviewing, psychoeducation, and structured activities that emphasize the link between pain, negative cognitions (i.e., catastrophizing), avoidance behaviors, and mood. About one third of the day is devoted to in vivo practice of relaxation-based skills including diaphragmatic breathing, guided imagery, pain-reduction visualization, and biofeedback. Additionally, adolescents participate in several hands-on activities designed to enhance mind-body regulation including mindfulness practice (eating mindfully), art therapy, and aromatherapy. Adolescents complete interactive workbooks throughout the program; at the end of the day, each adolescent works one-on-one with staff to create a written and personalized pain management plan emphasizing the adaptive coping strategies each adolescent preferred during the day. Adolescents were additionally provided with a pain management tool kit inclusive of recorded relaxation exercises, a biofeedback card, and other small tools to enhance their pain management regimen.
The parent program includes psychoeducation regarding pain in the context of adolescent development, didactic and vignette-based practice of an adaptive parent communication response style (i.e., reflective listening), and concrete tools for setting up behavior plans to scaffold an adolescent's return to function for school, sleep, daily activities, and exercise. All parents are provided with a take-home workbook inclusive of neuroscience and psychoeducational materials as well as a list of resources to further solidify the information they learned.
In addition there will be peer support for parents and adolescents in this program. During the 1 day intervention families and youth will be encouraged to share discussions regarding their health journeys. A guest speaker will be invited to both groups sharing their experiences and journey of utilizing psychologically based interventions to assist with reducing pain and stress and associated disability. These speakers have not received training for this portion.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with chronic pain | – | Behavioral: Workshop, Behavioral: Education |
| Caregivers of children with chronic pain | – | Behavioral: Workshop, Behavioral: Education |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 11 - 17 with chronic pain and their parents or caregivers
Key inclusion criteria (2 listed)
- 11 years to 17 years
- Ability to provide informed consent
Key exclusion criteria (2 listed)
- Cognitive Delay that may impact completion of questionnaires and involvement of youth group at workshop.
- Families without access to internet to complete 1 week, 1 month and 3 month follow up questionnaires.
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 |
|---|---|---|
| Workshopone-day (6 hour) program to help children and their parents or caregivers learn how to better manage chronic pain | Behavioural | Caregivers of children with chronic pain, Children with chronic pain |
| EducationThe parent program includes psychoeducation regarding pain in the context of adolescent development, didactic and vignette-based practice of an adaptive parent communication response style (i.e., reflective listening), and concrete tools for setting up behavior plans to scaffold an adolescent's return to function for school, sleep, daily activities, and exercise. All parents are provided with a take-home workbook inclusive of neuroscience and psychoeducational materials as well as a list of resources to further solidify the information they learned. | Behavioural | Caregivers of children with chronic pain, Children with chronic pain |
Primary outcome
Assess the efficacy of this program in change of pain interference: PROMIS
Time frame: up to 3 months after workshop
Pediatric pain interference over the past 7 days on scale of 1 - 5. 1=Never, 2=Almost Never, 3=Sometimes, 4=Often, 5=Almost Always
Assess the efficacy of this program in change of pain interference: Pain Self Efficacy Scal - Adolescent
Time frame: up to 3 months after workshop
Questionnaire to assess confidence with doing daily tasks when in pain. Scale of 1-5. 1=very sure, 2=pretty sure, 3=in the middle, 4=pretty unsure, 5=very unsure
Assess the efficacy of this program in change of pain interference: Functional Disability Inventory
Time frame: up to 3 months after workshop
Questionnaire relating to difficulty of doing regular activities. Scale of 0 - 4. 0=no trouble, 1=a little trouble, 2=some trouble, 3=a lot of trouble, 4=impossible
Assess the efficacy of this program in change of pain interference: Post-Workshop Questionnaire for Parent/Caregiver
Time frame: up to 3 months after workshop
Use of questionnaire to measure child's opinion of eductional material during workshop. Scale of 1 -5. 1=Strongly disagree, 2=disagree, 3=unsure, 4=Agree, 5=Strongly Agree
Assess the efficacy of this program in change of pain interference: Pain Catastrophizing Scale
Time frame: up to 3 months after workshop
Assess thoughts and feelings when participant is in pain. Scale 0-4. 0=Not at all, 1=to a slight degree, 2=to a moderate degree, 3=to a great degree, 4=all the time
Assess the efficacy of this program in change of pain interference: Pediatric Pain Screen Tool
Time frame: up to 3 months after workshop
Assess child's pain location and interference in daily life. Yes/No answers
Assess the efficacy of this program in change of pain interference: Treatment History Questionnaire
Time frame: up to 2 weeks before workshop
Questionnaire to capture demographics, medical history, goals of treatment
Assess the efficacy of this program in change of pain interference: Adult Responses to Children's Symptoms
Time frame: up to 3 months after workshop
Parent/Caregiver questionnaire to assess child's symptoms. Scale of 0 - 5, with 0=never and 5=often
Assess the efficacy of this program in change of pain interference: Pain Self Efficacy Scale - Child
Time frame: up to 3 months after workshop
Questionnaire to assess confidence with doing daily tasks when in pain. Scale of 1-5. 1=very sure, 2=pretty sure, 3=in the middle, 4=pretty unsure, 5=very unsure
Determine if the workshop increases children's pain self-efficacy and improves patients function at our institution: PROMIS
Time frame: Up to 3 months following workshop
Pediatric pain interference over the past 7 days on scale of 1 - 5. 1=Never, 2=Almost Never, 3=Sometimes, 4=Often, 5=Almost Always
Determine if the workshop increases children's pain self-efficacy and improves patients function at our institution: Post-Workshop Questionnaire for Parent/Caregiver
Time frame: up to 3 months after workshop
Use of questionnaire to measure parent/caregiver's opinion of eductional material during workshop. Scale of 1 -5. 1=Strongly disagree, 2=disagree, 3=unsure, 4=Agree, 5=Strongly Agree
Determine if the workshop increases children's pain self-efficacy and improves patients function at our institution: Functional Disability
Time frame: Up to 3 months following workshop
Questionnaire relating to difficulty of doing regular activities. Scale of 0 - 4. 0=no trouble, 1=a little trouble, 2=some trouble, 3=a lot of trouble, 4=impossible
Determine if the workshop increases parental management strategies of their child's pain at our institution: PROMIS
Time frame: Up to 3 months following workshop
Pediatric pain interference over the past 7 days on scale of 1 - 5. 1=Never, 2=Almost Never, 3=Sometimes, 4=Often, 5=Almost Always
Determine if the workshop increases parental management strategies of their child's pain at our institution: Pain Evaluation Questionnaire
Time frame: Up to 3 months following workshop
Use of questionnaires to measure parental management strategies.
Determine if the workshop increases parental management strategies of their child's pain at our institution: Functional Disability
Time frame: Up to 3 months following workshop
Questionnaire relating to difficulty of doing regular activities. Scale of 0 - 4. 0=no trouble, 1=a little trouble, 2=some trouble, 3=a lot of trouble, 4=impossible
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 1 May 2024.
- Background: PubMed 29048506Coakley R, Wihak T, Kossowsky J, Iversen C, Donado C. The Comfort Ability Pain Management Workshop: A Preliminary, Nonrandomized Investigation of a Brief, Cognitive, Biobehavioral, and Parent Training Intervention for Pediatric Chronic Pain. J Pediatr Psychol. 2018 Apr 1;43(3):252-265. doi: 10.1093/jpepsy/jsx112.
- Background: PubMed 11014396Perquin CW, Hazebroek-Kampschreur AA, Hunfeld JA, van Suijlekom-Smit LW, Passchier J, van der Wouden JC. Chronic pain among children and adolescents: physician consultation and medication use. Clin J Pain. 2000 Sep;16(3):229-35. doi: 10.1097/00002508-200009000-00008.
- Background: PubMed 15046285Roth-Isigkeit A, Thyen U, Raspe HH, Stoven H, Schmucker P. Reports of pain among German children and adolescents: an epidemiological study. Acta Paediatr. 2004 Feb;93(2):258-63.
- 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.
Jacob AuBuchon, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Washington University School of Medicine at 1 site in United States.
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 2 inclusion and 2 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 1 May 2024. 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 United States. 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. 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?
Assess the efficacy of this program in change of pain interference: PROMIS (time frame: up to 3 months after workshop). The study lists 15 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 NCT04081454, which also lists 3 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 1 May 2024.