Depression SymptomsNCT06401070
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
A study testing Plesterin and Press needle acupuncture in people with Depression Symptoms and Chronic Pain, run by Universitas Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Depression Symptoms, Chronic Pain
- What is being tested?
- Plesterin and Press needle acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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. There's 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).
- Conditions
- Depression Symptoms, Chronic Pain
- Being tested
- Plesterin, Press needle acupuncture
- Keywords
- acupuncture, auricular acupuncture, ear acupuncture, depression symptoms, chronic pain, press needle
- Medical subject headings
- Depression, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlesterinDevice
The plaster used is a round plaster that resembles the shape of an acupuncture press needle.
Press needle acupunctureDevice
Press needle acupuncture is a modality of acupuncture using tiny and very thin needles.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | The control group was given a placebo press needle acupuncture (using plaster) Receives: Device: Plesterin |
| Intervention Group | Experimental | The intervention group was given press needle acupuncture Receives: Device: Press needle acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9 (PHQ-9)
Consists of nine questions that correspond to the nine questions of the diagnostic criteria for major depressive disorder of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). In each area assessed, there is a rating from 0 to 3 based on increasing frequency of difficulties. PHQ-9 scoring uses a 4-point Likert scale: 0 = "Not at all," 1 = "Some days," 2 = "More than half the days," and 3 = "Almost every day." With a total score ranging from 0 to 27
Measured: before intervention, the first day, seventh day, and fourteenth-day post intervention
Heart Rate Variability (HRV).
To measure cardiac autonomic dysfunction non-invasively. HRV can be interpreted as the variability of heart rate. Methods for measuring HRV are categorized as time domain, frequency domain, geometric, and nonlinear.
Measured: before intervention, the first day, seventh day, and fourteenth-day post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start1 May 2024 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression SymptomsStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nur Khasanah, Universitas Indonesia
- Investigators
- Nur Khasanah, Principal investigator, Medical Faculty Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401070
- Sponsor's protocol ID
- DP.04.03
- Status last verified
- May 2024
- First submitted
- 2 May 2024
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06401070
- Acronym / sponsor ID
- DP.04.03
- Conditions
- Depression Symptoms, Chronic Pain
- Keywords
- acupuncture, auricular acupuncture, ear acupuncture, depression symptoms, chronic pain, press needle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. There's 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Device: PlesterinThe control group was given a placebo press needle acupuncture (using plaster) |
| Intervention Group | Experimental | Device: Press needle acupunctureThe intervention group was given press needle acupuncture |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlesterinThe plaster used is a round plaster that resembles the shape of an acupuncture press needle. | Device | Control group |
| Press needle acupuncturePress needle acupuncture is a modality of acupuncture using tiny and very thin needles. | Device | Intervention Group |
Primary outcome
Patient Health Questionnaire-9 (PHQ-9)
Time frame: before intervention, the first day, seventh day, and fourteenth-day post intervention
Consists of nine questions that correspond to the nine questions of the diagnostic criteria for major depressive disorder of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). In each area assessed, there is a rating from 0 to 3 based on increasing frequency of difficulties. PHQ-9 scoring uses a 4-point Likert scale: 0 = "Not at all," 1 = "Some days," 2 = "More than half the days," and 3 = "Almost every day." With a total score ranging from 0 to 27
Heart Rate Variability (HRV).
Time frame: before intervention, the first day, seventh day, and fourteenth-day post intervention
To measure cardiac autonomic dysfunction non-invasively. HRV can be interpreted as the variability of heart rate. Methods for measuring HRV are categorized as time domain, frequency domain, geometric, and nonlinear.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nur Khasanah principal investigator
Medical Faculty Universitas Indonesia
Questions about this trial
What is this clinical trial studying?
A study testing Plesterin and Press needle acupuncture in people with Depression Symptoms and Chronic Pain, run by Universitas Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nur Khasanah (085640177389, nur.khasanah11@ui.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-9 (PHQ-9) (time frame: before intervention, the first day, seventh day, and fourteenth-day post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.