Pain Burden in Children and Adolescents With Cerebral Palsy

NCT04219020 | Completed

• 2 other identifiers: 2019/618829207
• Study Type: observational
• Target: 588
• Locations: 5 countries
• Sites: 5

Brief Summary

Pain in children and adolescents with cerebral palsy (CP) is a significant health challenge that so far has received too little attention. We lack knowledge on how pain is experienced, its consequences and of perceived support in managing pain. The overarching aim of the CPPain-program is to reduce pain experience, pain interference (e.g. pain burden) in children and adolescents living with CP. CPPain has a prospective cohort comparative design and will include before- and after measurements and process evaluation of a nested intervention. This protocol concerns qualitative and quantitative data collection for the baseline of the CPPain program. The aim of the baseline data collection is to contribute in-depth knowledge of the pain burden in children and adolescents with CP. This knowledge is required to develop targeted pain-diminishing interventions in this vulnerable group of children with a high burden of challenges related to their chronic disease. In the next step, nested intervention will be co-created with children and adolescents with CP, their parents as well as health care professionals, and other professional caregivers involved in or responsible for management of pain based on existing research and baseline findings.

Conditions

Cerebral Palsy

Keywords

Pain intensity; Pain prevalence; Pain interference; Self-reported and parent-reported pain; Pain predictors; Management of pain

Outcome Measures

Primary Outcomes (1)

• Pain interference

  Measured with a modified version of the Brief Pain Inventory (BPI) (Engel, 2009). mBPI has 12 items scored from 0 to 10 points, giving a total score ranging from 0 to 120 points where zero means that pain does not interfere with function while higher scores indicate a more negative outcome (higher pain interference)

  3 years

Study Arms (3)

Children with a CP diagnosis

Children younger than 18 years with a CP diagnosis. Intervention will be determined later based on baseline results. Self- and/or proxy-reported survey and/or participation in interviews. Parents of all participants will provide proxy report. Children with CP \> 8 years of age and cognitively able (approx. 50%) will provide self-report.

Other: Co-created intervention

Controls

Siblings (12-17 years) of children with cerebral palsy. No intervention, self-reported survey.

Health Care Professionals

Health Care Professionals identified as providers of pain care. No intervention, interview participants

Interventions

Co-created intervention OTHER

Children with a CP diagnosis

Eligibility Criteria

• Age: 0 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Children 0-18 years with a CP diagnosis. Siblings 12-18 years (controls). Clinicians identified as providers of pain-related care

You may qualify if:

• Children 0-18 years with a CP diagnosis registered in the Cerebral Palsy Registry of Norway (CPRN), or recruited through child habilitation centers, patient organizations or social media advertizing campains (USA, Canada, Finland \& Sweden)
• Siblings 12-18 years of a child/adolescent with CP (survey only)
• Clinicians identified by parents and/or children with CP as providers of pain-related care

You may not qualify if:

• Unable or unwilling to provide self-report
• Not able to communicate in English or Norwegian
• Lives with the child less than 50% of the time (parental interviews)

Sponsors & Collaborators

• Sykehuset Telemark: lead
• Gillette Children's Specialty Healthcare: collaborator
• IWK Health Centre: collaborator
• The Hospital of Vestfold: collaborator
• University of Oslo: collaborator
• Oslo University Hospital: collaborator
• University of Minnesota: collaborator
• Örebro University, Sweden: collaborator
• Dalhousie University: collaborator
• Lund University: collaborator
• Arcada University of Applied Sciences: collaborator

Study Sites (5)

Gillette Children's Speciality Healthcare

Saint Paul, Minnesota, 55101, United States

Location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Arcadia University of Applied Sciences

Helsinki, 00560, Finland

Location

Telemark Hospital Trust

Skien, 3728, Norway

Location

Lund University

Lund, 221 00, Sweden

Location

Related Links

• Official web site for the CPPain program

MeSH Terms

Conditions

Cerebral Palsy; Pain

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Guro L. Andersen, PhD

  The Hospital of Vestfold

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: January 6, 2020
• Study Start: March 12, 2020
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Locations

SE (1); US (1); CA (1); FI (1); NO (1)