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Completed

NCT Number: NCT06750640

Acupoint Thermal Radiation Characteristics in Adolescents with MDD

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.

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the Third affiliated hospital of Zhejiang Chinese Medical university

Hangzhou, Zhejiang, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Acupoint emperature

    Time frame: 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 outcomes

  1. The Self-Rating Depression Scale (SDS) Scores

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Xiaomei Shao

Other

Collaborators

  • First People's Hospital of Hangzhou
  • Zhejiang Provincial Tongde Hospital

Registry information

Official study title

Acupoint Thermal Radiation Characteristics in Adolescents with Major Depressive Disorder and Establishment of Diagnostic Model

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 27, 2024
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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