NCT06824428

Brief Summary

The aim of this study was to evaluate whether the disease subtype affects the presence of chronic pain and pain perception threshold in pediatric patients followed up with the diagnosis of attention deficit and hyperactivity disorder, and to evaluate the factors that may be related to pain perception threshold in disease subtypes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 7, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

February 16, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2025

Completed
Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

10 months

First QC Date

February 7, 2025

Last Update Submit

December 26, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • pressure pain threshold

    The pressure pain threshold will be assessed with a manual pressure algometer (Baseline Dolorimtre®). The patients' pain perception thresholds will be measured bilaterally in the midfrontal region, the midpoint of the trapezius muscle, the lateral epicondyle, the midpoint of the web between the 1st and 2nd fingers, the greater trochanter, and the medial crease of the knee. During the measurement, the 1.52 cm2 flat circular probe of the algometer will be placed on the relevant area and the pressure will be increased by 1 kg/second. Patients will be asked to express their pain by saying 'stop' or raising their hands when they feel slight discomfort. The value for each reference area will be obtained by calculating the arithmetic mean of the paired measurements.

    Baseline

Secondary Outcomes (5)

  • Presence of chronic pain

    Baseline

  • Pain score

    Baseline

  • Duration of chronic pain

    Baseline

  • Sociodemographic data of patient

    Baseline

  • Sociodemographic data of patient's parents

    Baseline

Study Arms (3)

Predominantly Inattentive

Patients diagnosed with inattentive subtype of attention deficit disorder with hyperactivity according to DSM-5 diagnostic criteria.

Other: Pain perception threshold

Predominantly Hyperactive-Impulsive

Patients diagnosed with hyperactive-impulsive subtype of attention deficit disorder with hyperactivity according to DSM-5 diagnostic criteria.

Other: Pain perception threshold

Inattentive and Hyperactive-Impulsive Combination

Patients diagnosed with mix subtype of attention deficit disorder with hyperactivity according to DSM-5 diagnostic criteria.

Other: Pain perception threshold

Interventions

The patients' pressure pain threshold will be evaluated with a manual pressure algometer (Baseline Dolorimtre®).The patients' pain perception thresholds will be measured bilaterally in the midfrontal region, the midpoint of the trapezius muscle, the lateral epicondyle, the midpoint of the web between the 1st and 2nd fingers, the greater trochanter, and the medial crease of the knee.

Inattentive and Hyperactive-Impulsive CombinationPredominantly Hyperactive-ImpulsivePredominantly Inattentive

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients will be selected from among those who apply to Edirne Sultan 1. Murat State Hospital Child and Adolescent Mental Health and Diseases polyclinic.

You may qualify if:

  • Diagnosed with attention deficit and hyperactivity disorder according to DSM-5 diagnostic criteria
  • Being between the ages of 6-17
  • Being at a clinically normal mental level

You may not qualify if:

  • Having verbal and visual communication problems
  • Having a history of perinatal complications or physical head trauma
  • Having comorbid psychiatric disorders other than oppositional defiant disorder and conduct disorder
  • Known history of chronic physical and neurological disease (such as cerebral palsy, diabetes, epilepsy, autoimmune diseases, liver and kidney failure)
  • Presence of substance or alcohol use disorder
  • Having a genetic disorder diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sultan 1. Murat State Hospital

Edirne, 22030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • İbrahim Tiryaki, MD

    Sultan 1. Murat State Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 7, 2025

First Posted

February 13, 2025

Study Start

February 16, 2025

Primary Completion

December 26, 2025

Study Completion

December 26, 2025

Last Updated

December 30, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

If requested, the data of the study will be shared by the researchers.

Locations