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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Predominantly Inattentive
Patients diagnosed with inattentive subtype of attention deficit disorder with hyperactivity according to DSM-5 diagnostic criteria.
Other: Pain perception threshold
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.
Other: Pain perception threshold
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.
Other: Pain perception threshold
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Baseline
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
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
Sociodemographic data of patient's parents
Time Frame: Baseline
Age, occupation, education level and psychiatric disease history of mother and father
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sultan 1. Murat State Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 16, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 26, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 26, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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