Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06401070
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-05-02
Brief Title:
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
Sponsor:
Indonesia University
Organization:
Indonesia University
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Depression is characterized by behavioral cognitive and emotional changes Depression can have a negative impact on decreasing quality of life because in many cases it occurs long-term Chronic pain is often accompanied by various mental disorders of which depression is the most common accompanying mental disorder Chronic pain and depression themselves influence each other and are closely related with globally around 30 to 45 of patients with chronic pain present with depression and around 52 to 65 patients with depression suffer from chronic pain
There are various therapeutic options for treating depression that aim to shorten depressive episodes and relieve symptoms Multimodal therapy is needed in treating depression with chronic pain because there are biopsychosocial aspects involved Pharmacological therapy has long-term side effects and the risk of drug dependence Apart from that depression patients with chronic pain often receive pharmacological therapy such as non-steroidal anti-inflammatory drugs NSAIDs and opioids where the side effects and risk of drug dependence are higher Therefore it is necessary to choose a therapeutic modality that is relatively safe and effective in treating depression in chronic pain In various studies it has been proven that acupuncture is an efficient and safe therapy for chronic pain patients with depression Auricular acupuncture using pr ess needles has minimal pain and can be applied longer on acupuncture points
This study aimed to assess the effectiveness of the auricular needle press on Patient with Depression Symptoms in Chronic Pain This study was a double-blinded randomized clinical trial and was carried out on outpatients at Dr Cipto Mangunkusumo National General Hospital Jakarta and Soerojo Hospital Magelang Theres also a collaborative study between the medical acupuncture department and the psychiatry department
This study includes 60 participants who will be randomly allocated into 2 groups the press needle and sham press needle groups The press needles will be placed at 6 auricular points bilaterally MA-TF1 Shenmen MA-IC7 Heart and MA-IT1 Cingulate gyrus
The outcomes that will be assessed in this study are Patient Health Questionnaire-9 PHQ-9 score and Heart Rate Variability HRV
There are various therapeutic options for treating depression that aim to shorten depressive episodes and relieve symptoms Multimodal therapy is needed in treating depression with chronic pain because there are biopsychosocial aspects involved Pharmacological therapy has long-term side effects and the risk of drug dependence Apart from that depression patients with chronic pain often receive pharmacological therapy such as non-steroidal anti-inflammatory drugs NSAIDs and opioids where the side effects and risk of drug dependence are higher Therefore it is necessary to choose a therapeutic modality that is relatively safe and effective in treating depression in chronic pain In various studies it has been proven that acupuncture is an efficient and safe therapy for chronic pain patients with depression Auricular acupuncture using pr ess needles has minimal pain and can be applied longer on acupuncture points
This study aimed to assess the effectiveness of the auricular needle press on Patient with Depression Symptoms in Chronic Pain This study was a double-blinded randomized clinical trial and was carried out on outpatients at Dr Cipto Mangunkusumo National General Hospital Jakarta and Soerojo Hospital Magelang Theres also a collaborative study between the medical acupuncture department and the psychiatry department
This study includes 60 participants who will be randomly allocated into 2 groups the press needle and sham press needle groups The press needles will be placed at 6 auricular points bilaterally MA-TF1 Shenmen MA-IC7 Heart and MA-IT1 Cingulate gyrus
The outcomes that will be assessed in this study are Patient Health Questionnaire-9 PHQ-9 score and Heart Rate Variability HRV
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None