Comfortability Workshop

Chronic Pain Clinical Trial

Official title:

The Comfort Ability Workshop: Improving Pain Treatment for Children and Their Families

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04081454
• Other study ID #: 201907083
• Status: Completed
• Start date: August 14, 2021
• Est. completion date: December 18, 2023

Study information

• Verified date: April 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 18, 2023
• Est. primary completion date: December 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

Inclusion Criteria:

1. 11 years to 17 years

2. Ability to provide informed consent

Exclusion Criteria:

1. Cognitive Delay that may impact completion of questionnaires and involvement of youth group at workshop.

2. Families without access to internet to complete 1 week, 1 month and 3 month follow up questionnaires.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Workshop
one-day (6 hour) program to help children and their parents or caregivers learn how to better manage chronic pain
• Education
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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine/Barnes Jewish Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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