Emotional Bodymaps in Pediatric Pain Patients and Their P... | NCT05902234

Studies
Emotional Bodymaps in Pediatric Pain Patients and Their Parents.

NCT05902234

Sponsor

Helsinki University Central Hospital

Status

Recruiting

Last Update Posted

Sep 10, 2025Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Pediatric Pain

Interventions

interdiciplinary treatment

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 20, 2023Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

May 23, 2023

First Submission Date that Met QC Criteria

Jun 5, 2023

First Posted Date

Jun 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2025

Last Update Posted Date

Sep 10, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pediatric pain patients and their parents		patients and their parents	Behavioral: interdiciplinary treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
interdiciplinary treatment	Behavioral	Normal interdiciplinary treatment path	Pediatric pain patients and their parents

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
emotional bodymaps	sensations of emotion in ones body	10months

Secondary Outcomes

Measure	Description	Time Frame
pain PROMIS	pain interference and intensity	10 months
psychological flexibility	measure of psychological flexibility	10 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

fluency in finnish language

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

pediatric pain clinic patients and their parents

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Reetta M Sipilä, PhD	Contact	+358407272353		reetta.sipila@hus.fi

Overall Officials

Name	Affiliation	Role
Reetta M Sipilä, PhD	HUS, HY	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New Childrens Hospital	Recruiting	Helsinki			Finland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided