Pediatric PainPedPainEmotNCT05902234
Emotional Bodymaps in Pediatric Pain Patients and Their Parents.
An observational study of Pediatric Pain, run by Helsinki University Central Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Pain
- What is being tested?
- interdiciplinary treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 600 participants
- Where
- 1 siteFinland
- Study dates
- 20 Oct 2023to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: pediatric pain clinic patients and their parents
Who may be able to join
- fluency in finnish language
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
New Childrens Hospital
Helsinki
Reetta M Sipilä, PhD, +358406812427, reetta.sipila@hus.fi
About this study
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.
- Conditions
- Pediatric Pain
- Being tested
- interdiciplinary treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interdiciplinary treatmentBehavioural
Normal interdiciplinary treatment path
| Study group | Role | What they receive |
|---|---|---|
| Pediatric pain patients and their parents | patients and their parents Receives: Behavioral: interdiciplinary treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
emotional bodymaps
sensations of emotion in ones body
Measured: 10months
Secondary outcomes (2)
pain PROMIS
pain interference and intensity
Measured: 10 months
psychological flexibility
measure of psychological flexibility
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start20 Oct 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric PainStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reetta Sipilä, Helsinki University Central Hospital
- Investigators
- Reetta M Sipilä, PhD, Principal investigator, HUS, HY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902234
- Sponsor's protocol ID
- HUS/1301/2023
- Acronym
- PedPainEmot
- Status last verified
- Sep 2025
- First submitted
- 23 May 2023
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Bodymaps in Pediatric Pain Patients and Their Parents.
- ClinicalTrials.gov ID
- NCT05902234
- Acronym / sponsor ID
- PedPainEmot / HUS/1301/2023
- Conditions
- Pediatric Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric pain patients and their parents | – | Behavioral: interdiciplinary treatmentpatients and their parents |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pediatric pain clinic patients and their parents
Key inclusion criteria (1 listed)
- fluency in finnish language
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interdiciplinary treatmentNormal interdiciplinary treatment path | Behavioural | Pediatric pain patients and their parents |
Primary outcome
emotional bodymaps
Time frame: 10months
sensations of emotion in ones body
2 secondary outcomes
pain PROMIS
Time frame: 10 months
psychological flexibility
Time frame: 10 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reetta M Sipilä, PhD principal investigator
HUS, HY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Pain, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reetta M Sipilä, PhD (+358407272353, reetta.sipila@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
emotional bodymaps (time frame: 10months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.