Pain ThresholdNCT06824428
The Pain Perception Threshold in Attention Deficit Disorder With Hyperactivity
An observational study of Pain Threshold and Attention Deficit Disorder With Hyperactivity (ADHD), run by Sultan 1. Murat State Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Pain Threshold, Attention Deficit Disorder With Hyperactivity (ADHD)
- What is being tested?
- Pain perception threshold
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Feb 2025to 26 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Pain perception threshold
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain perception thresholdOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Predominantly Inattentive | Patients diagnosed with inattentive subtype of attention deficit disorder with hyperactivity according to DSM-5 diagnostic criteria. Receives: 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. Receives: 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. Receives: Other: Pain perception threshold |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (5)
Presence of chronic pain
It will be questioned whether there has been continuous pain in any part of the body for at least 3 months.
Measured: Baseline
Pain score
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.
Measured: Baseline
Duration of chronic pain
The duration of pain that has continued for at least 3 months in any part of the body will be questioned.
Measured: Baseline
Sociodemographic data of patient
gender, age, height, weight, age of onset of complaints, duration of medication use, number of siblings, primary caregiver
Measured: Baseline
Sociodemographic data of patient's parents
Age, occupation, education level and psychiatric disease history of mother and father
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start16 Feb 2025
- Primary completion26 Dec 2025
- Study completion26 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ThresholdStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan 1. Murat State Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alper Mengi, Sultan 1. Murat State Hospital
- Investigators
- İbrahim Tiryaki, MD, Principal investigator, Sultan 1. Murat State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824428
- Sponsor's protocol ID
- 29/12/2024-Number:04
- Status last verified
- Dec 2025
- First submitted
- 7 Feb 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If requested, the data of the study will be shared by the researchers.
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Disease Subtype Affect the Pain Perception Threshold in Children Diagnosed With Attention Deficit Disorder With Hyperactivity?
- ClinicalTrials.gov ID
- NCT06824428
- Acronym / sponsor ID
- 29/12/2024-Number:04
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Sultan 1. Murat State HospitalOther government
- Study start
- 16 Feb 2025 (actual)
- Primary completion
- 26 Dec 2025 (actual)
- Study completion
- 26 Dec 2025 (actual)
- First posted
- 13 Feb 2025 (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 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Predominantly Inattentive | – | Other: Pain perception thresholdPatients diagnosed with inattentive subtype of attention deficit disorder with hyperactivity according to DSM-5 diagnostic criteria. |
| Predominantly Hyperactive-Impulsive | – | Other: Pain perception thresholdPatients diagnosed with hyperactive-impulsive subtype of attention deficit disorder with hyperactivity according to DSM-5 diagnostic criteria. |
| Inattentive and Hyperactive-Impulsive Combination | – | Other: Pain perception thresholdPatients diagnosed with mix subtype of attention deficit disorder with hyperactivity according to DSM-5 diagnostic criteria. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Pain perception thresholdThe 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. | Other | Inattentive and Hyperactive-Impulsive Combination, Predominantly Hyperactive-Impulsive, Predominantly Inattentive |
Primary outcome
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.
5 secondary outcomes
Presence of chronic pain
Time frame: Baseline
Pain score
Time frame: Baseline
Duration of chronic pain
Time frame: Baseline
Sociodemographic data of patient
Time frame: Baseline
Sociodemographic data of patient's parents
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Individual participant dataSharing planned: Yes. If requested, the data of the study will be shared by the researchers.
Related trials for Pain Threshold
Not yet recruitingEarly Phase 1
Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder
Opioid Use Disorder, Alcohol Intoxication
Recruiting
Characterization of Nociception Phenotype in Individuals With Intellectual Disability
Intellectual Disability
Active, not recruiting
Pain Sensitivity and Pruritus of Peripheral Nerves
ITCH
Not yet recruitingObservational study
Biophysical Assessments of Acupuncture Points in Inflammatory Bowel Disease
Inflammatory Bowel Disease (IBD)
Recruiting
Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds
Angina (Stable), Coronary Artery Disease(CAD)
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. This study is not recruiting at the moment.
İbrahim Tiryaki, MD principal investigator
Sultan 1. Murat State Hospital
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 Pain Threshold and Attention Deficit Disorder With Hyperactivity (ADHD), run by Sultan 1. Murat State Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 30 Dec 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pressure pain threshold (time frame: Baseline). 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 30 Dec 2025.