Acupoint Thermal Radiation Characteristics in Adolescents with MDD

NCT06750640 | Completed

• 1 other identifier: 2022ZX010-IRT
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Modern studies have confirmed that skin temperature changes at acupoints when the body is under pathological conditions. This suggests that changes in the thermal radiation characteristics of acupoints can objectively respond to the symptoms of a disease. In this study, the investigators first evaluated reproducibility of acupoint temperature measurement by IRT. Secondly, the investigators explored the thermal radiation characteristics of MDD-related acupoints, built the diagnostic model for adolescent depression severity and the diagnostic model for MDD in adolescents based on acupoint temperature. Our research findings will provide new ideas, methods and visualisations for early screening, auxiliary diagnosis and condition assessment of MDD in adolescents.

Conditions

Major Depression

Keywords

Major Depression Disorder; acupoint temperature; adolescent

Outcome Measures

Primary Outcomes (1)

• Acupoint emperature

  Temperature of acupoints was measured by infrared thermography (IRT). IRT was not be performed on female subjects during their menstrual and ovulatory periods.

  Baseline

Secondary Outcomes (1)

• The Self-Rating Depression Scale (SDS) Scores

  Baseline

Study Arms (2)

Healthy Control group

There were 40 healthy control participants in the Healthy Control group.

Diagnostic Test: Infrared thermography

Major Depression Disorder group

There were 60 MDD patients in the MDD group. All MDD adolescents received at least one IRT test. 26 MDD adolescents were detected by 2 investigators and 2 investigators both made 2 independent measurements in a week. 30 MDD subjects were detected the bilateral same name acupoint temperatures.

Diagnostic Test: Infrared thermography

Interventions

Infrared thermography DIAGNOSTIC_TEST

A thermograph (NEC InfRec R450, Avio Infrared Technologies Co., Ltd., Tokyo) was used to record thermal images. The infrared camera was fixed on a tripod 1 m away from the subject to ensure that no shaking movements or vibrations occurred during the recording of thermal images. MDD related acupoints on the inner and outer sides of the limbs were detected. Appropriate body position was selected according to the different parts to be detected. Using the automatic interval saving shooting mode, one thermal picture was taken at 10-s intervals, 3 pictures were taken for each subject.

Healthy Control group; Major Depression Disorder group

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The diagnostic criteria of MDD were based on criteria proposed by the International Classification of Diseases 10th Edition (ICD-10). Healthy control participants were determined by a recent depression screening report for confirming their mental health conditions.

You may qualify if:

• years≤ age\<18 years;
• SDS score \<53;
• Adolescents with normal cognitive function can cooperate with the study;
• Adolescents and guardians agree to the study plan and sign the informed consent form.
• years≤ age\<18 years;
• Self-rating Depression Scale (SDS) score ≥ 53;
• Language, cognition and communication ability are normal;
• Patients and guardians agree to the study plan and sign the informed consent form.

You may not qualify if:

• Severe anxiety, schizophrenia, or other serious mental illnesses;
• There are pigmentation, redness, infection or scarring on the skin at the site of detection;
• Patients with severe systemic diseases and their complications, serious infections, and major diseases of viscera, tissues, and systems;
• Female patients who were pregnant or lactating;
• Female patients who were during, or in proximity (±2 days) to their menstruation or ovulation;
• Patients with a body temperature ≥37.3°C;
• Inability to cooperate during the examination;
• Participating in any other clinical trials.

Sponsors & Collaborators

• Xiaomei Shao: lead
• Zhejiang Provincial Tongde Hospital: collaborator
• First People's Hospital of Hangzhou: collaborator

Study Sites (1)

the Third affiliated hospital of Zhejiang Chinese Medical university

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 27, 2024
• Study Start: March 5, 2022
• Primary Completion: June 30, 2024
• Study Completion: November 30, 2024
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)