Acupoint Thermal Radiation Characteristics in Adolescents with MDD

NCT ID: NCT06750640

Last Updated: 2024-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-05

Study Completion Date

2024-11-30

Brief Summary

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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

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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.

Conditions

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Major Depression

Keywords

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Major Depression Disorder acupoint temperature adolescent

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy Control group

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

Infrared thermography

Intervention Type 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.

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.

Infrared thermography

Intervention Type 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.

Interventions

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Infrared thermography

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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.


* 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

* 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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zhejiang Provincial Tongde Hospital

OTHER

Sponsor Role collaborator

First People's Hospital of Hangzhou

OTHER

Sponsor Role collaborator

Xiaomei Shao

OTHER

Sponsor Role lead

Responsible Party

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Xiaomei Shao

Prof

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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the Third affiliated hospital of Zhejiang Chinese Medical university

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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2022ZX010-IRT

Identifier Type: -

Identifier Source: org_study_id