Cerebral PalsyNCT03468270
Pain Coping Strategies in Children With CP
An observational study of Cerebral Palsy and Pain, run by Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française at 1 site in France.
Trial summary
The aim of the study is to describe pain coping strategies and their evolution in children and adolescent with cerebral palsy. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Cerebral Palsy, Pain
- How many people
- 142 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2013to 1 Jun 2015
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The patients were recruited in the services of 2 French Red Cross Physical Medicine and Rehabilitation Centers in France. All parents and children were informed orally about the procedure, and parental consent as the child's consent was obtained in writing.
Who may be able to join
- Confirmed diagnostic of cerebral palsy
- GMFCS I, II, III, IV
- Oral language skills with syntactic abilities
Who cannot join
- Acute pain episode
- severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
France1 site
Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues
Lyon, 69005
About this study
Official title: Pain Coping Strategies in Children With Cerebral Palsy
The aim of the study is to describe pain coping strategies and their evolution in children and adolescent with cerebral palsy.
Read the detailed description
Towards the end of the 20th century, Lazarus and Folkmann developed the concept that the individual provides "cognitive and behavioral efforts to control, reduce or tolerate the internal or external demands that threaten or exceed his or her resources". These cognitive and behavioral efforts are grouped under the term "coping", which describes a process rather than personality traits or abilities. Coping is not about controlling stress but about diminishing, avoiding, tolerating or accepting it.
The pain, "unpleasant sensory and emotional experience related to a bodily injury", aims to warn the individual that the integrity of his body is threatened, and is thus a real "stressor". It will lead to the choice of coping strategies, which depends in part on the characteristics of the individual (his beliefs, stress endurance, anxiety propensity) and environmental variables (characteristics of the painful situation, social support and emotional connections, information about the threatening situation). Many studies have shown that the strategies used to cope with chronic pain in adults and children play a major role in the adjustment of patients to their pathology, in terms of emotional distress, disability, and quality of life. The different types of strategies have been widely studied in the literature in so-called "typical" children. Active strategies classically found in pediatrics are distraction, cognitive self-instruction, and problem solving. These active strategies are said to be positive because they have been proven to help children manage pain more effectively than passive strategies such as catastrophism, helplessness, or seeking social support, which are dysfunctional because they are not focused on the problem and increase the negative consequences associated with pain.
This study is about children with cerebral palsy (CP) because the great variability and complexity of the manifestations of the pathology and the therapeutic treatment make it that there is a big risk for the child to experience pain, with a prevalence of pain ranging from 60% to 73%, depending on the evaluation methods. Research has done a great deal in recent years to improve the assessment and management of inborn or induced pain in children with disabilities, with many validated recommendations, even though this still appears to be a neglected comorbidity in PC. However, coping strategies of PC children with pain have never been studied. The purpose of this work is to describe these strategies in PC children and adolescents, as well as their evolution.
- Conditions
- Cerebral Palsy, Pain
- Medical subject headings
- Cerebral Palsy, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
PPCI-F (Pediatric Pain and Coping inventory - French)
Coping strategies used to face pain are measured by the French version of the PPCI. This scale leads to 4 subscores, corresponding to 4 different strategies.
Measured: At inclusion
Secondary outcomes (2)
SPQ (Structured Pain Questionnaire)
This questionnaire assesses the location and frequency of pain episodes (<1 time / month, 1 time / month, 2-3 times / month, 1 time / week, 2-6 times / week, each day), their duration (<4 weeks, 4 weeks, 3 months,> 3 months) and pain intensity (0 to 100 on scoring scale).
Measured: At inclusion
Evolution of PPCI-F scores according to age.
The evolution of the coping strategies used according to the age of the patient is assessed by the Spearman correlation.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start1 Jul 2013
- Primary completion1 Jun 2015
- Study completion1 Jun 2015
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468270
- Sponsor's protocol ID
- COPING
- Status last verified
- Mar 2018
- First submitted
- 12 Mar 2018
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Coping Strategies in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03468270
- Acronym / sponsor ID
- COPING
- Conditions
- Cerebral Palsy, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge FrançaiseUniversity, hospital or other
- Study start
- 1 Jul 2013 (actual)
- Primary completion
- 1 Jun 2015 (actual)
- Study completion
- 1 Jun 2015 (actual)
- First posted
- 16 Mar 2018 (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 aim of the study is to describe pain coping strategies and their evolution in children and adolescent with cerebral palsy.
Detailed description
Towards the end of the 20th century, Lazarus and Folkmann developed the concept that the individual provides "cognitive and behavioral efforts to control, reduce or tolerate the internal or external demands that threaten or exceed his or her resources". These cognitive and behavioral efforts are grouped under the term "coping", which describes a process rather than personality traits or abilities. Coping is not about controlling stress but about diminishing, avoiding, tolerating or accepting it.
The pain, "unpleasant sensory and emotional experience related to a bodily injury", aims to warn the individual that the integrity of his body is threatened, and is thus a real "stressor". It will lead to the choice of coping strategies, which depends in part on the characteristics of the individual (his beliefs, stress endurance, anxiety propensity) and environmental variables (characteristics of the painful situation, social support and emotional connections, information about the threatening situation). Many studies have shown that the strategies used to cope with chronic pain in adults and children play a major role in the adjustment of patients to their pathology, in terms of emotional distress, disability, and quality of life. The different types of strategies have been widely studied in the literature in so-called "typical" children. Active strategies classically found in pediatrics are distraction, cognitive self-instruction, and problem solving. These active strategies are said to be positive because they have been proven to help children manage pain more effectively than passive strategies such as catastrophism, helplessness, or seeking social support, which are dysfunctional because they are not focused on the problem and increase the negative consequences associated with pain.
This study is about children with cerebral palsy (CP) because the great variability and complexity of the manifestations of the pathology and the therapeutic treatment make it that there is a big risk for the child to experience pain, with a prevalence of pain ranging from 60% to 73%, depending on the evaluation methods. Research has done a great deal in recent years to improve the assessment and management of inborn or induced pain in children with disabilities, with many validated recommendations, even though this still appears to be a neglected comorbidity in PC. However, coping strategies of PC children with pain have never been studied. The purpose of this work is to describe these strategies in PC children and adolescents, as well as their evolution.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The patients were recruited in the services of 2 French Red Cross Physical Medicine and Rehabilitation Centers in France. All parents and children were informed orally about the procedure, and parental consent as the child's consent was obtained in writing.
Key inclusion criteria (3 listed)
- Confirmed diagnostic of cerebral palsy
- GMFCS I, II, III, IV
- Oral language skills with syntactic abilities
Key exclusion criteria (2 listed)
- Acute pain episode
- severe cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PPCI-F (Pediatric Pain and Coping inventory - French)
Time frame: At inclusion
Coping strategies used to face pain are measured by the French version of the PPCI. This scale leads to 4 subscores, corresponding to 4 different strategies.
2 secondary outcomes
SPQ (Structured Pain Questionnaire)
Time frame: At inclusion
Evolution of PPCI-F scores according to age.
Time frame: At inclusion
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 19 Mar 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cerebral Palsy and Pain, run by Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française at 1 site in France.
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 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 19 Mar 2018. 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 France. 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?
PPCI-F (Pediatric Pain and Coping inventory - French) (time frame: At inclusion). 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 19 Mar 2018.