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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Nur Khasanah
Principal Investigator
Medical Faculty Universitas Indonesia
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported