Comfortability Workshop

NCT04081454 | Completed

• 1 other identifier: 201907083
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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 non-pharmaceutical strategies for improved pain management. Youth ages 11-18 with chronic or recurrent pain are eligible to sign up for Comfort Ability.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (15)

• 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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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.

  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

  Up to 3 months following workshop

Study Arms (2)

Children with chronic pain

Behavioral: Workshop; Behavioral: Education

Caregivers of children with chronic pain

Behavioral: Workshop; Behavioral: Education

Interventions

Workshop BEHAVIORAL

one-day (6 hour) program to help children and their parents or caregivers learn how to better manage chronic pain

Caregivers of children with chronic pain; Children with chronic pain

Education BEHAVIORAL

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.

Caregivers of children with chronic pain; Children with chronic pain

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 11 - 17 with chronic pain and their parents or caregivers

You may qualify if:

• years to 17 years
• Ability to provide informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine/Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (3)

• 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.

  PMID: 29048506 BACKGROUND

• Perquin 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.

  PMID: 11014396 BACKGROUND

• Roth-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.

  PMID: 15046285 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Jacob AuBuchon, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2019
• First Posted: September 9, 2019
• Study Start: August 14, 2021
• Primary Completion: December 18, 2023
• Study Completion: December 18, 2023
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)