- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06824428
The Pain Perception Threshold in Attention Deficit Disorder With Hyperactivity
December 26, 2025 updated by: Alper Mengi, Sultan 1. Murat State Hospital
Can the Disease Subtype Affect the Pain Perception Threshold in Children Diagnosed With Attention Deficit Disorder With Hyperactivity?
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
84
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Edirne, Turkey (Türkiye), 22030
- Sultan 1. Murat State Hospital
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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
Accepts Healthy Volunteers
No
Sampling Method
Non-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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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 |
|---|---|
|
Predominantly Inattentive
Patients diagnosed with inattentive subtype of attention deficit disorder with hyperactivity according to DSM-5 diagnostic criteria.
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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.
|
|
Predominantly Hyperactive-Impulsive
Patients diagnosed with hyperactive-impulsive subtype of attention deficit disorder with hyperactivity according to DSM-5 diagnostic criteria.
|
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 Combination
Patients diagnosed with mix subtype of attention deficit disorder with hyperactivity according to DSM-5 diagnostic criteria.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pressure pain threshold
Time Frame: Baseline
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Presence of chronic pain
Time Frame: Baseline
|
It will be questioned whether there has been continuous pain in any part of the body for at least 3 months.
|
Baseline
|
|
Pain score
Time Frame: Baseline
|
The patients' pain score will be evaluated with the Numerical Rating Scale (NRS).
A 10 cm long horizontal straight line will be used in the NRS evaluation.
Before the evaluation, the patient will be informed that a value of 0 represents no pain and a value of 10 represents the most severe pain felt to date.
Patients will be asked to answer by considering the average of their pain over the last 3 days.
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Baseline
|
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Duration of chronic pain
Time Frame: Baseline
|
The duration of pain that has continued for at least 3 months in any part of the body will be questioned.
|
Baseline
|
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Sociodemographic data of patient
Time Frame: Baseline
|
gender, age, height, weight, age of onset of complaints, duration of medication use, number of siblings, primary caregiver
|
Baseline
|
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Sociodemographic data of patient's parents
Time Frame: Baseline
|
Age, occupation, education level and psychiatric disease history of mother and father
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Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: İbrahim Tiryaki, MD, Sultan 1. Murat State Hospital
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)
February 16, 2025
Primary Completion (Actual)
December 26, 2025
Study Completion (Actual)
December 26, 2025
Study Registration Dates
First Submitted
February 7, 2025
First Submitted That Met QC Criteria
February 7, 2025
First Posted (Actual)
February 13, 2025
Study Record Updates
Last Update Posted (Actual)
December 30, 2025
Last Update Submitted That Met QC Criteria
December 26, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29/12/2024-Number:04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
If requested, the data of the study will be shared by the researchers.
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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