Acupoint Thermal Radiation Characteristics in Adolescents with MDD

Completed

• Conditions: Major Depression

• Registration Number: NCT06750640
• Lead Sponsor: Xiaomei Shao

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.

Detailed Description

A total of 100 subjects were included, 60 adolescent with MDD (MDD group) and 40 healthy controls (HC group). All subjects accepted IRT detection.The random selection of 30 adolescent with MDD allowed the collection of the bilateral same name acupoint temperatures. Intra- and inter-observer reproducibility for the patients were examined in some randomly selected patients 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.

Study Timeline

• Study Start: 2022-03-05
• Primary Completion: 2024-06-30
• Study Completion: 2024-11-30
• Status Verified: 2024-12
• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2024-12-20
• Study First Posted: 2024-12-27
• Last Update Submitted: 2024-12-27
• Last Update Posted: 2024-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Inclusion criteria for the healthy control participants:

• 12years≤ 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.

Inclusion criteria for the major depression disorder participants:

• 12years≤ 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.

Exclusion Criteria

Exclusion criteria both for the healthy control participants and major depression disorder participants:

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The Self-Rating Depression Scale (SDS) Scores	Baseline	The standard score is the total of all scores multiplied by 1.25 to the nearest whole number on this scale, which has 20 questions. A standard score below 53 is normal; 53-62 is mild depression; 63-72 is moderate depression; 72 or more is severe depression.

Trial Locations

Locations (1)

the Third affiliated hospital of Zhejiang Chinese Medical university; 🇨🇳 Hangzhou, Zhejiang, China