Cerebral PalsyCPPainNCT04219020
Pain Burden in Children and Adolescents With Cerebral Palsy
An observational study of Cerebral Palsy, run by Sykehuset Telemark at 5 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 67 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Co-created intervention
- How many people
- 588 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 12 Mar 2020to 31 Aug 2024
- How long will I take part?
- 3 Years
- 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 0 to 67 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children 0-18 years with a CP diagnosis. Siblings 12-18 years (controls). Clinicians identified as providers of pain-related care
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
United States1 site
Gillette Children's Speciality Healthcare
Saint Paul, Minnesota, 55101
About this study
Official title: Pain and Pain Burden in Children and Adolescents With Cerebral Palsy - the CPPain Program
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.
Read the detailed description
Background and aim. Children and adolescents with cerebral palsy (CP) are at high risk for pain and their pain is frequently underestimated and undermanaged. They often experience a substantial pain burden from the pain itself and its influence on all aspects of their life, for example ability to perform daily activities, participate socially, sleep, or on overall quality of life. The overarching aim of the CPPain-program is to reduce the pain burden in children and adolescents living with CP.
Study design. The CPPain has a prospective cohort comparative design and will include before- and after measurements and process evaluation of a nested intervention. This registration concerns the CPPain baseline and includes a multinational survey (the CPPain survey) and qualitative interviews with children and adolescents with CP, their parents/caregivers and health care professionals. The nested intervention will later be developed based on findings from the baseline.
Qualitative data collection (the CPPain survey). The study population for the CPPain survey will include children younger than 18 years with a CP diagnosis (=primary participants) and their siblings (12-17 years) as controls. Parents of all primary participants will provide proxy report. Children with CP > 8 years of age and cognitively able (approx. 50%) and siblings (12-17 years) will provide self-report. The survey will include a set of previously published and validated measures that assess aspects of pain (experience, interference and management), performance of daily activities, mental health, Health-Related Quality of Life (HRQoL), and participation. These measures include modified versions of Dalhousie Pain Interview (DPI) and Brief Pain Inventory (BPI), Pain Catastrophizing Scale (PCS), The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD), Revised Children's Anxiety and Depression Scale (RCADS-25), KidScreen, and Child and Adolescent Scale of Participation (CASP). We have also added a researcher-developed questionnaire on COVID-19 and pain. We will have three versions of the survey: Parent proxy, Self-report - full (12-18), and self-report - abbreviated (8-12 and older children with cognitive limitations). In addition to self- and/or proxy-reported survey data, demographic and disability-related data already registered in either national registers or electronic medical charts will be collected. Survey data will primarily be collected using an electronic survey. The Clinical Data Management System (CDMS) used for the eCRF in this study is Viedoc. The setup of the study specific eCRF in Viedoc will be performed by Research Support Services CTU, Oslo University Hospital (OUS).
Qualitative data collection. Potential participants for the child and parent interviews will be identified from the CPPain survey or clinicians in the child habilitation services. Inclusion criteria are school-aged children and adolescents (8-18 years) with cerebral palsy who have pain, determined from their or their parents' responses to the modified Dalhousie Pain Interview. If the child is unable to self-report or do not wish to participate only the parent/caregiver will be included.A purposeful sampling strategy will be used to ensure a diverse sample concerning child and parent age and gender, as well as the child's level of physical and cognitive disability and severity of pain burden. We estimate that we will include 15-20 child/parent dyads, but the final number will depend upon the richness of the material and data saturation.Both individual semi-structured interviews and focus groups will be used to answer the research objectives. Interview guides cover experiences with pain and its impact on life and living for children and parents respectively, parents' perception of their child's pain burden and its impact, as well as how pain is managed, including a detailed mapping of both the current and ideal help network. From the existing help network, identified by interview participants, health care professionals will be identified and recruited for a second round of interviews.
Data analysis. Quantitative questionnaire and register data will be analyzed using appropriate statistical methods for comparing groups and analyzing time trends in close cooperation with the study's statistician. Stratification will be used to investigate sub groups. Analysis will be adjusted for appropriate sociodemographic variables. SPSS will be the main tool for statistical analysis, while some of the more complex analysis will require the use of R. Other specialized software will be applied as needed. Qualitative data from interviews and from unstructured responses to survey questions will be analyzed using appropriate qualitative methods; primarily content, thematic and/or network analysis. NVivo will be the main qualitative analysis tool. Qualitative and quantitative data will be combined and analyzed from either a quantitative or qualitative perspective to provide a more comprehensive understanding of the phenomenon.
- Conditions
- Cerebral Palsy
- Being tested
- Co-created intervention
- Keywords
- Pain intensity, Pain prevalence, Pain interference, Self-reported and parent-reported pain, Pain predictors, Management of pain
- Medical subject headings
- Cerebral Palsy, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-created interventionOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start12 Mar 2020
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 588 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Sykehuset Telemark
- Sponsor type
- Other government
- Collaborators
- Gillette Children's Specialty Healthcare, IWK Health Centre, The Hospital of Vestfold, University of Oslo, Oslo University Hospital, University of Minnesota, Örebro University, Sweden, Dalhousie University, Lund University, Arcada University of Applied Sciences
- Responsible party
- Sponsor
- Investigators
- Guro L. Andersen, PhD, Principal investigator, The Hospital of Vestfold
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219020
- Sponsor's protocol ID
- 2019/618
- Other IDs
- 829207
- Acronym
- CPPain
- Status last verified
- Oct 2024
- First submitted
- 3 Jan 2020
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will not be available for sharing until the program is completed
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain and Pain Burden in Children and Adolescents With Cerebral Palsy - the CPPain Program
- ClinicalTrials.gov ID
- NCT04219020
- Acronym / sponsor ID
- CPPain / 2019/618
- Conditions
- Cerebral Palsy
- Keywords
- Pain intensity, Pain prevalence, Pain interference, Self-reported and parent-reported pain, Pain predictors, Management of pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 588 participants (actual)
- Lead sponsor
- Sykehuset TelemarkOther government
- Collaborators
- Gillette Children's Specialty Healthcare, IWK Health Centre, The Hospital of Vestfold, University of Oslo, Oslo University Hospital, University of Minnesota, Örebro University, Sweden, Dalhousie University, Lund University, Arcada University of Applied Sciences
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 6 Jan 2020 (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.
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.
Detailed description
Background and aim. Children and adolescents with cerebral palsy (CP) are at high risk for pain and their pain is frequently underestimated and undermanaged. They often experience a substantial pain burden from the pain itself and its influence on all aspects of their life, for example ability to perform daily activities, participate socially, sleep, or on overall quality of life. The overarching aim of the CPPain-program is to reduce the pain burden in children and adolescents living with CP.
Study design. The CPPain has a prospective cohort comparative design and will include before- and after measurements and process evaluation of a nested intervention. This registration concerns the CPPain baseline and includes a multinational survey (the CPPain survey) and qualitative interviews with children and adolescents with CP, their parents/caregivers and health care professionals. The nested intervention will later be developed based on findings from the baseline.
Qualitative data collection (the CPPain survey). The study population for the CPPain survey will include children younger than 18 years with a CP diagnosis (=primary participants) and their siblings (12-17 years) as controls. Parents of all primary participants will provide proxy report. Children with CP > 8 years of age and cognitively able (approx. 50%) and siblings (12-17 years) will provide self-report. The survey will include a set of previously published and validated measures that assess aspects of pain (experience, interference and management), performance of daily activities, mental health, Health-Related Quality of Life (HRQoL), and participation. These measures include modified versions of Dalhousie Pain Interview (DPI) and Brief Pain Inventory (BPI), Pain Catastrophizing Scale (PCS), The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD), Revised Children's Anxiety and Depression Scale (RCADS-25), KidScreen, and Child and Adolescent Scale of Participation (CASP). We have also added a researcher-developed questionnaire on COVID-19 and pain. We will have three versions of the survey: Parent proxy, Self-report - full (12-18), and self-report - abbreviated (8-12 and older children with cognitive limitations). In addition to self- and/or proxy-reported survey data, demographic and disability-related data already registered in either national registers or electronic medical charts will be collected. Survey data will primarily be collected using an electronic survey. The Clinical Data Management System (CDMS) used for the eCRF in this study is Viedoc. The setup of the study specific eCRF in Viedoc will be performed by Research Support Services CTU, Oslo University Hospital (OUS).
Qualitative data collection. Potential participants for the child and parent interviews will be identified from the CPPain survey or clinicians in the child habilitation services. Inclusion criteria are school-aged children and adolescents (8-18 years) with cerebral palsy who have pain, determined from their or their parents' responses to the modified Dalhousie Pain Interview. If the child is unable to self-report or do not wish to participate only the parent/caregiver will be included.A purposeful sampling strategy will be used to ensure a diverse sample concerning child and parent age and gender, as well as the child's level of physical and cognitive disability and severity of pain burden. We estimate that we will include 15-20 child/parent dyads, but the final number will depend upon the richness of the material and data saturation.Both individual semi-structured interviews and focus groups will be used to answer the research objectives. Interview guides cover experiences with pain and its impact on life and living for children and parents respectively, parents' perception of their child's pain burden and its impact, as well as how pain is managed, including a detailed mapping of both the current and ideal help network. From the existing help network, identified by interview participants, health care professionals will be identified and recruited for a second round of interviews.
Data analysis. Quantitative questionnaire and register data will be analyzed using appropriate statistical methods for comparing groups and analyzing time trends in close cooperation with the study's statistician. Stratification will be used to investigate sub groups. Analysis will be adjusted for appropriate sociodemographic variables. SPSS will be the main tool for statistical analysis, while some of the more complex analysis will require the use of R. Other specialized software will be applied as needed. Qualitative data from interviews and from unstructured responses to survey questions will be analyzed using appropriate qualitative methods; primarily content, thematic and/or network analysis. NVivo will be the main qualitative analysis tool. Qualitative and quantitative data will be combined and analyzed from either a quantitative or qualitative perspective to provide a more comprehensive understanding of the phenomenon.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children with a CP diagnosis | – | Other: Co-created interventionChildren 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. |
| 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 |
Who may qualify
- Ages
- 0 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children 0-18 years with a CP diagnosis. Siblings 12-18 years (controls). Clinicians identified as providers of pain-related care
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
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 |
|---|---|---|
| Co-created intervention | Other | Children with a CP diagnosis |
Primary outcome
Pain interference
Time frame: 3 years
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)
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 16 Oct 2024.
- Official web site for the CPPain programLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Data will not be available for sharing until the program is completed
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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.
Guro L. Andersen, PhD principal investigator
The Hospital of Vestfold
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Sykehuset Telemark at 5 sites in 5 countries.
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 3 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 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada, Finland, Norway, Sweden. 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?
Pain interference (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2024.