NCT05902234

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Oct 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress61%
Oct 2023Dec 2027

First Submitted

Initial submission to the registry

May 23, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 13, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

October 20, 2023

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

4.2 years

First QC Date

May 23, 2023

Last Update Submit

September 9, 2025

Conditions

Pediatric Pain

Outcome Measures

Primary Outcomes (1)

  • emotional bodymaps

    sensations of emotion in ones body

    10months

Secondary Outcomes (2)

  • pain PROMIS

    10 months

  • psychological flexibility

    10 months

Study Arms (1)

Pediatric pain patients and their parents

patients and their parents

Behavioral: interdiciplinary treatment

Interventions

interdiciplinary treatmentBEHAVIORAL

Normal interdiciplinary treatment path

Pediatric pain patients and their parents

Eligibility Criteria

Age10 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

pediatric pain clinic patients and their parents

You may qualify if:

  • fluency in finnish language

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Childrens Hospital

Helsinki, Finland

RECRUITING

Study Officials

  • Reetta M Sipilä, PhD

    HUS, HY

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Reetta M Sipilä, PhD

CONTACT

+358407272353reetta.sipila@hus.fi

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 23, 2023

First Posted

June 13, 2023

Study Start

October 20, 2023

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

September 10, 2025

Record last verified: 2025-09

Locations

FI(1)