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Search / Trial NCT06401070

Effect of Auricular Press Needle on Improvement of Patient Health Questionnaire-9 (PHQ-9) and Heart Rate Variability (HRV) Patient With Depression Symptoms in Chronic Pain

Launched by INDONESIA UNIVERSITY · May 2, 2024

Trial Information

Current as of July 01, 2025

Not yet recruiting

Keywords

Acupuncture Auricular Acupuncture Ear Acupuncture Depression Symptoms Chronic Pain Press Needle

ClinConnect Summary

This clinical trial is studying the effects of a treatment called auricular press needle therapy on patients who experience symptoms of depression along with chronic pain. Chronic pain and depression often go hand in hand, affecting a person's quality of life. The researchers want to see if using small press needles on specific points in the ear can help improve mood and heart health in these patients. The trial will include 60 participants between the ages of 18 and 59 who have been experiencing depression symptoms and chronic pain for more than three months.

Participants in the study will be randomly assigned to one of two groups: one receiving the actual press needle treatment and the other receiving a sham (fake) treatment. They will have their depression levels measured using a questionnaire, and their heart health will be assessed through heart rate variability tests. This study is important because it seeks a safe and effective alternative to traditional medications, which can have side effects and risks of dependence. If you're interested in participating, you'll need to meet certain criteria, including having moderate depression symptoms (as measured by a specific scale) and chronic pain but not having severe mental health issues or certain medical conditions.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Men or women aged 18-59 years.
  • Subjects who experience depression symptoms with chronic pain
  • Subjects with VAS \>= 30 mm and \< 70 mm from 100 mm during activity (daily activities or light exercise).
  • Duration of pain \> 3 months.
  • Patient Health Questionnaire-9 Items (PHQ-9) score 5-19 on a scale of 0-27.
  • Willing to take part in this study until completion and sign the informed consent.
  • Exclusion Criteria:
  • Pain caused by malignancy.
  • Patients diagnosed with major depression, depressive symptoms accompanied by psychotic symptoms, and depressive symptoms with antidepressant therapy.
  • patients with medical emergencies or pregnancy.
  • Infection, scar tissue, or malignancy at the acupuncture area.
  • Anatomical abnormalities in the ear shape.
  • Having hypersensitivity reaction to previous acupuncture therapy (metal allergy, atopy, keloid, or other skin hypersensitivity).
  • Patients with cognitive impairment or impaired consciousness.

About Indonesia University

Indonesia University is a leading academic institution dedicated to advancing healthcare through rigorous clinical research. As a trial sponsor, the university leverages its extensive expertise in medical science and collaboration with top-tier researchers to design and implement innovative clinical trials. Committed to ethical standards and patient safety, Indonesia University aims to contribute to the global body of knowledge in medicine, enhance therapeutic options, and improve health outcomes for diverse populations. Through its comprehensive approach, the university fosters an environment of scientific inquiry and collaboration, driving progress in clinical research and education.

Locations

Patients applied

0 patients applied

Trial Officials

Nur Khasanah

Principal Investigator

Medical Faculty Universitas Indonesia

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported