- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05902234
Emotional Bodymaps in Pediatric Pain Patients and Their Parents. (PedPainEmot)
March 20, 2024 updated by: Reetta Sipilä, Helsinki University Central Hospital
The aims of this study are to find out how pain may alter the experience of emotions in the body in pediatric pain patients and how how their parent feel the emotions in their bodies.
We are also interested how this possible effect is mediated by the duration and location of pain, mood changes or with the experience of bullying.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
600
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Reetta M Sipilä, PhD
- Phone Number: +358407272353
- Email: reetta.sipila@hus.fi
Study Locations
-
-
-
Helsinki, Finland
- Recruiting
- New Childrens Hospital
-
Contact:
- Reetta M Sipilä, PhD
- Phone Number: +358406812427
- Email: reetta.sipila@hus.fi
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
pediatric pain clinic patients and their parents
Description
Inclusion Criteria:
- fluency in finnish language
Exclusion Criteria:
- none
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pediatric pain patients and their parents
patients and their parents
|
Normal interdiciplinary treatment path
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
emotional bodymaps
Time Frame: 10months
|
sensations of emotion in ones body
|
10months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain PROMIS
Time Frame: 10 months
|
pain interference and intensity
|
10 months
|
psychological flexibility
Time Frame: 10 months
|
measure of psychological flexibility
|
10 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Reetta M Sipilä, PhD, HUS, HY
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)
October 20, 2023
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
May 23, 2023
First Submitted That Met QC Criteria
June 5, 2023
First Posted (Actual)
June 13, 2023
Study Record Updates
Last Update Posted (Actual)
March 21, 2024
Last Update Submitted That Met QC Criteria
March 20, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- HUS/1301/2023
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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