AnxietyNCT06768359
The Effect of Manual Acupuncture and Standard Therapy on Anxiety and Quality of Life Scores in Cancer Patients
A study testing Manual acupuncture and standard therapy in people with Anxiety and Quality of Life, run by Universitas Indonesia at 2 sites in Indonesia.
Trial summary
The goal of this clinical trial is to prove that the combination of acupuncture therapy and standard therapy is more effective in reducing anxiety and improving the quality of life of cancer patients. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Anxiety, Quality of Life, Cancer
- What is being tested?
- Manual acupuncture and standard therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 2 sitesIndonesia
- Study dates
- 24 Mar 2025to 30 Nov 2025
- 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
- Patients aged 18-59 years.
- Diagnosed with cancer in the last 6 months
- Experiencing moderate to severe anxiety (assessed by HAM-A Score > 14)
- Willing to participate in this study until completion and sign an informed consent.
Who cannot join
- Cancer patients with unstable hemodynamics
- Cancer patients with brain metastases
- Patients who have been diagnosed with anxiety disorders and have received pharmacological therapy from psychiatrists before.
- Patients who have contraindications to manual acupuncture (there are wounds or infections at the point to be punctured, patients are allergic to stainless steel, patients are phobic of needles)
- Patients who are uncooperative and do not allow acupuncture therapy (patients who are restless, angry)
- Patients with poor liver function (SGOT (Serum Glutamic Oxaloacetic Transaminase) /SGPT (serum glutamate pyruvate transaminase)values increase 2-3 times the normal value)
Show all 9Show fewer
- Patients with blood clotting disorders (platelets <50,000, INR (International Normalized Ratio) > 2)
- Patients with neutropenia (Absolute neutrophil count <1000)
- Patients with overt DIC (disseminated intravascular coagulation) and acute venous or arterial thrombosis
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
RS Kanker Dharmais
Jakarta, 11420
Universitas Indonesia
Jakarta Pusat, DKI Jakarta, 10430
About this study
The goal of this clinical trial is to prove that the combination of acupuncture therapy and standard therapy is more effective in reducing anxiety and improving the quality of life of cancer patients. The main questions it aims to answer are:
- Can the combination of manual acupuncture and standard therapy reduce anxiety based on Hamilton Anxiety Rating Scale (HAM-A) scores in cancer patients compared to the sham acupuncture and standard therapy group?
- Can the combination of manual acupuncture and standard therapy improve the quality of life of cancer patients based on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC-QLQ C30) compared to the sham acupuncture and standard therapy group?
Read more
Participants will:
Get manual acupuncture therapy and also standard therapy, such as oral Benzodiazepin and supportive psychotherapy or sham acupuncture therapy and the standard therapy (Benzodiazepin and supportive psychotherapy) every day for 6 days.
Researchers will compare the changes of anxiety scores and quality of life between cancer patients who received manual acupuncture therapy and standard therapy, and cancer patients who received sham acupuncture and standard therapy.
- Conditions
- Anxiety, Quality of Life, Cancer
- Being tested
- Manual acupuncture and standard therapy, Sham acupuncture and standard therapy
- Medical subject headings
- Anxiety Disorders, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual acupuncture and standard therapyProcedure or surgery
Manual acupuncture is acupuncture needle insertion was done perpendicularly to the acupuncture points GV20, EXHN3, HT7, and PC6 using Huanqiu needle measuring 0.25 x 25mm with mild stimulation rotation technique at a speed of 60x/minute and needle retention for 30 minutes. Therapy was performed every day for 6 days.
Standard therapy is anxiolytic drugs and supportive psychotherapy given to patients according to the decision of the psychiatrist treating the patient.
Sham acupuncture and standard therapyProcedure or surgery
Sham acupuncture is when acupuncture needles are inserted into acupuncture points, but do not actually penetrate the skin, only attached to the plaster. Therapy was performed every day for 6 days.
Standard therapy is anxiolytic drugs and supportive psychotherapy given to patients according to the decision of the psychiatrist treating the patient.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The manual acupuncture and standard therapy Receives: Procedure: Manual acupuncture and standard therapy |
| Control Group | Sham comparator | The sham acupuncture and standard therapy Receives: Procedure: Sham acupuncture and standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton anxiety rating scale (HAM-A) score
One tool to measure the degree of anxiety symptoms is a questionnaire. Scores range from 0-56.
Measured: 6 days
Secondary outcomes (1)
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC-QLQ C30) score
Questionnaire to assess the quality of life of cancer patients with anxiety. Scores range from 0-100
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start24 Mar 2025
- Primary completion15 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Factorial
- Model description
- The manual acupuncture and standard therapy will be designed as the intervention group, while the sham acupuncture and standard therapy will be designed as the control group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deity Indrayati Nugraha, Universitas Indonesia
- Investigators
- KEPK FKUI-RSCM, Principal investigator, The Health Research Ethics Commitee of Faculty of MedicineKEPK RS Kanker Dharmais, Principal investigator, The Health Research Ethics Commitee of Dharmais Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768359
- Sponsor's protocol ID
- 24-12-1826
- Status last verified
- Jan 2026
- First submitted
- 23 Dec 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Manual Acupuncture and Standard Therapy on Anxiety and Quality of Life Scores in Cancer Patients
- ClinicalTrials.gov ID
- NCT06768359
- Acronym / sponsor ID
- 24-12-1826
- Conditions
- Anxiety, Quality of Life, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 15 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 10 Jan 2025 (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.
The goal of this clinical trial is to prove that the combination of acupuncture therapy and standard therapy is more effective in reducing anxiety and improving the quality of life of cancer patients. The main questions it aims to answer are:
- Can the combination of manual acupuncture and standard therapy reduce anxiety based on Hamilton Anxiety Rating Scale (HAM-A) scores in cancer patients compared to the sham acupuncture and standard therapy group?
- Can the combination of manual acupuncture and standard therapy improve the quality of life of cancer patients based on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC-QLQ C30) compared to the sham acupuncture and standard therapy group?
Participants will:
Get manual acupuncture therapy and also standard therapy, such as oral Benzodiazepin and supportive psychotherapy or sham acupuncture therapy and the standard therapy (Benzodiazepin and supportive psychotherapy) every day for 6 days.
Researchers will compare the changes of anxiety scores and quality of life between cancer patients who received manual acupuncture therapy and standard therapy, and cancer patients who received sham acupuncture and standard therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The manual acupuncture and standard therapy will be designed as the intervention group, while the sham acupuncture and standard therapy will be designed as the control group
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Procedure: Manual acupuncture and standard therapyThe manual acupuncture and standard therapy |
| Control Group | Sham comparator | Procedure: Sham acupuncture and standard therapyThe sham acupuncture and standard therapy |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged 18-59 years.
- Diagnosed with cancer in the last 6 months
- Experiencing moderate to severe anxiety (assessed by HAM-A Score > 14)
- Willing to participate in this study until completion and sign an informed consent.
Key exclusion criteria (9 listed)
- Cancer patients with unstable hemodynamics
- Cancer patients with brain metastases
- Patients who have been diagnosed with anxiety disorders and have received pharmacological therapy from psychiatrists before.
- Patients who have contraindications to manual acupuncture (there are wounds or infections at the point to be punctured, patients are allergic to stainless steel, patients are phobic of needles)
- Patients who are uncooperative and do not allow acupuncture therapy (patients who are restless, angry)
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 |
|---|---|---|
| Manual acupuncture and standard therapyManual acupuncture is acupuncture needle insertion was done perpendicularly to the acupuncture points GV20, EXHN3, HT7, and PC6 using Huanqiu needle measuring 0.25 x 25mm with mild stimulation rotation technique at a speed of 60x/minute and needle retention for 30 minutes. Therapy was performed every day for 6 days. Standard therapy is anxiolytic drugs and supportive psychotherapy given to patients according to the decision of the psychiatrist treating the patient. | Procedure or surgery | Intervention Group |
| Sham acupuncture and standard therapySham acupuncture is when acupuncture needles are inserted into acupuncture points, but do not actually penetrate the skin, only attached to the plaster. Therapy was performed every day for 6 days. Standard therapy is anxiolytic drugs and supportive psychotherapy given to patients according to the decision of the psychiatrist treating the patient. | Procedure or surgery | Control Group |
Primary outcome
Hamilton anxiety rating scale (HAM-A) score
Time frame: 6 days
One tool to measure the degree of anxiety symptoms is a questionnaire. Scores range from 0-56.
1 secondary outcome
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC-QLQ C30) score
Time frame: 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
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.
KEPK FKUI-RSCM principal investigator
The Health Research Ethics Commitee of Faculty of Medicine
KEPK RS Kanker Dharmais principal investigator
The Health Research Ethics Commitee of Dharmais Cancer Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual acupuncture and standard therapy in people with Anxiety and Quality of Life, run by Universitas Indonesia at 2 sites in 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton anxiety rating scale (HAM-A) score (time frame: 6 days). 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 8 Jan 2026.