CClinicalTrials.gg
CompletedNCT03468270Updated Mar 19, 2018

Pain Coping Strategies in Children With CP

An observational study in Cerebral Palsy and Pain, sponsored by Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française. Completed at 1 site in France. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-03-19.

Sponsored by Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
142
Ages
5 Years to 18 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Cerebral Palsy
  • Pain

Browse trials for

03

Who can participate

Ages eligible
5 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • Confirmed diagnostic of cerebral palsy
  • GMFCS I, II, III, IV
  • Oral language skills with syntactic abilities

Exclusion criteria

Exclusion Criteria:

  • Acute pain episode
  • severe cognitive impairment
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
142 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At inclusion

Secondary outcomes

  1. 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).

    Time frame: At inclusion

  2. 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.

    Time frame: At inclusion

06

Study locations

1 site
  • Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues
    Lyon, 69005, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03468270
Lead sponsor
Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
Responsible party
Sponsor
First posted
Mar 16, 2018
Start date
Jul 1, 2013
Primary completion
Jun 1, 2015
Completion
Jun 1, 2015
Last update
Mar 19, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion