- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04883489
Pain Classification in Caregivers for Children With Cerebral Palsy
April 7, 2023 updated by: Ismail Saracoglu, Kutahya Health Sciences University
Clinical Classification of Musculoskeletal Pain in Caregivers for Children With Cerebral Palsy
The care of children with Cerebral Palsy is a process that continues for many years.
Individuals who take care of them experience musculoskeletal pain due to the difficulties they experience and face pain that becomes chronic over time.
For individuals who take care of children with CP, determining the types of chronic pain is important in order to clarify the classification criteria and for individuals to reach better living standards by tailoring the treatments they will receive.
Therefore, the aim of the study is to determine the types of chronic pain in caregivers for children with cerebral palsy.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kutahya, Turkey, 43000
- KutahyaHSU
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The convenience sampling will implement for this cross-sectional study.
Caregivers for children with Cerebral palsy chronic pain who presented at the different Educational and Rehabilitation Center in Kutahya will screen for eligibility by a clinician and will subsequently request to participate in this study.
Description
Inclusion Criteria:
- Having musculoskeletal pain complaints for the last 6 months or more
- experienced musculoskeletal pain or a sensitive disorder (like numbness, tingling, etc.) anywhere in body for which they stated a minimum score of 2 on a numeric pain rating scale
- pain that lasts at least 6 months
- To provide the documented diagnosis of Cerebral palsy of the child in the care of the participants.
Exclusion Criteria:
- Having severe psychological illness
- Having a cognitive dysfunction
- Not participating in the assessment or submitting incomplete answers for questionnaires
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric Pain Rating Scale
Time Frame: 1 minute
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The NPRS was used to assess the participants' pain levels.
In the NPRS, patients are asked to verbally rate the severity of their pain on a scale.
The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
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1 minute
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Margolis Pain Diagram
Time Frame: 5 minute
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The Margolis Pain Diagram, consists of a dorsal and a ventral drawing body, is used to assess the location and distribution of the pain.
Participants will ask to point out the place where they experience pain during the preceding 4 weeks for at least 24 hours
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5 minute
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Central Sensitization Inventory
Time Frame: 10 minute
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The Central Sensitization Inventory (CSI) aims to evaluate symptoms thought to be associated with nociplastic pain.
The CSI consists 25 items exploring emotional and somatic disorders associated with CS.
Each response is scored from 0 to 4, yielding a total score of 0 to 100.
A score of 40 or higher on the CSI means the presence of nociplastic pain.
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10 minute
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Short Form 36
Time Frame: 10 minute
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The Short Form-36 (SF-36) is widely used to measurement of health related quality of life (HRQoL) questionnaire.
SF-36 is a 36-item generic self-administered instrument consisting of 8 subscales related to various aspects of HRQoL: physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health.
The 8 subscales are scored from 0 to 100, with higher scores indicating better health status.
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10 minute
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantitative sensory test
Time Frame: 10 minute
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Quantitative sensory testing (QST) is a psychophysical method used to quantify somatosensory function in patients.
In QST will be used various stimuli static thermal (thermotest), static mechanical ( a painter brush), pinprick (a calibrated pin) and vibration ( a tuning folk).
QST will interrogate whether each stimulus is considered a sensory loss (negative sign) or sensory gain (positive sign or hyperalgesia).
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10 minute
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 15, 2021
Primary Completion (Actual)
July 1, 2021
Study Completion (Actual)
January 1, 2022
Study Registration Dates
First Submitted
May 7, 2021
First Submitted That Met QC Criteria
May 7, 2021
First Posted (Actual)
May 12, 2021
Study Record Updates
Last Update Posted (Actual)
April 10, 2023
Last Update Submitted That Met QC Criteria
April 7, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KutahyaHSU pain in caregivers
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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