AnxietyNCT07278284
Effectiveness of Press Needle Acupuncture in Reducing Preoperative Anxiety Among Patients Undergoing Tympanoplasty and Mastoidectomy at RSUD Kabupaten Tangerang
A study testing The press needle acupuncture in people with Anxiety, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to learn if press needle acupuncture works to treat preoperative anxiety in Tympanoplasty and Mastoidectomy at RSUD Kabupaten Tangerang in adults. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Anxiety
- What is being tested?
- The press needle acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteIndonesia
- Study dates
- 18 Jan 2026to 8 Jun 2026
- 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 diagnosed and scheduled for elective tympanoplasty and mastoidectomy under general anesthesia who experience preoperative anxiety.
- Patients aged 18-59 years.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Patients who have not taken any anti-anxiety medication within the past 24 hours.
- Willing to participate in the study until completion and sign the informed consent form.
Who cannot join
- Patients with a history of psychiatric disorders or those taking psychotropic medications.
- Presence of contraindications to acupuncture, including medical emergencies, pregnancy, thrombocytopenia with platelet count <50,000/µL, and any history of bleeding disorders.
- Presence of infection, scarring, or malignancy at the acupuncture site.
- Anatomical abnormalities of the auricle.
- History of hypersensitivity reactions to prior acupuncture therapy (such as metal allergy, keloids, or other cutaneous hypersensitivity reactions).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Press Needle Acupuncture on Preoperative Anxiety in Tympanoplasty and Mastoidectomy at RSUD Kabupaten Tangerang
The goal of this clinical trial is to learn if press needle acupuncture works to treat preoperative anxiety in Tympanoplasty and Mastoidectomy at RSUD Kabupaten Tangerang in adults. The main questions it aims to answer are:
Does the press-needle acupuncture administered one day before tympanoplasty and mastoidectomy significantly reduce preoperative anxiety levels-measured using the Amsterdam Preoperative Anxiety and Information Scale (APAIS)-compared with the sham press-needle group at 30 minutes after the intervention and 60 minutes before anesthesia induction?
Read more
Is there a difference in effectiveness between press-needle acupuncture and sham press-needle acupuncture in influencing Heart Rate Variability (HRV) among patients undergoing tympanoplasty and mastoidectomy at 30 minutes after the intervention, 60 minutes before anesthesia induction, 2 hours postoperatively, and 24 hours postoperatively?
Are there any adverse events associated with the use of press-needle acupuncture and sham press-needle acupuncture in patients with preoperative anxiety undergoing tympanoplasty and mastoidectomy?
Participants will:
Receive press-needle acupuncture or sham press-needle acupuncture one day before surgery Have the press needles left in place for a total of 3 days Undergo removal of the needles before hospital discharge Complete preoperative anxiety assessments and routine monitoring according to the study schedule
- Conditions
- Anxiety
- Being tested
- The press needle acupuncture, The sham press needle acupuncture
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The press needle acupunctureDevice
Insertion of acupuncture needles (Pyonex, Korea) measuring 0.2 × 0.9 mm at the auricular acupuncture points Micro Acupuncture - Triangular Fossa1 (MA-TF1) Shenmen, Micro Acupuncture - Anti Tragus2 (MA-AT2) Thalamus, and Micro Acupuncture - Inferior Concha7 (MA-IC7) Heart unilaterally (on the ear opposite to the surgical side), and insertion of a 0.2 × 1.5 mm press needle at the body point Extra - Head Neck3 (EX-HN3). The needles are inserted one day before surgery, with no stimulation performed either during insertion or while the press needles remain in place. Participants are instructed not to touch the application sites until the needles are removed.
The sham press needle acupunctureDevice
Application of round adhesive patches with a diameter resembling that of a press needle at the auricular points Micro Acupuncture - Triangular Fossa1 (MA-TF1) Shenmen, Micro Acupuncture - Anti Tragus2 (MA-AT2) Thalamus, and Micro Acupuncture - Inferior Concha7 (MA-IC7) Heart unilaterally (on the ear opposite to the surgical side), as well as at the body point Extra - Head Neck3 (EX-HN3). The patches are applied one day before surgery, with no stimulation performed either during application or while the patches remain in place. Participants are instructed not to touch the application sites until the patches are removed.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Press Needle Acupuncture Receives: Device: The press needle acupuncture |
| Control Group | Sham comparator | Sham press needle acupuncture Receives: Device: The sham press needle acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Amsterdam Preoperative Anxiety and Information Scale (APAIS)
The Amsterdam Preoperative Anxiety and Information Scale (APAIS) is a questionnaire consisting of six items rated on a 5-point Likert scale. These six items are divided into three components: anxiety related to anesthesia, anxiety related to the surgical procedure, and the need-for-information component. Higher scores indicate higher levels of preoperative anxiety and a greater need for information.
Measured: Baseline, 30 minutes post-intervention, 60 minutes before anesthesia induction
Heart Rate Variability (HRV)
Heart rate variability measurements using an HRV monitor (Polar H10) for 5 minutes in the seated position, with the corresponding application operated on the research assistant's smartphone.
Measured: Baseline, 30 minutes post-intervention, 60 minutes before anesthesia induction, 2 hours postoperatively, 24 hours postoperatively
Secondary outcomes (1)
Side effects
Reactions that occur during or after press-needle application, documented observationally using a monitoring sheet.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start18 Jan 2026
- Primary completion8 Jun 2026
- Study completion8 Jun 2026
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
- Parallel groups
- Model description
- The press needle acupuncture therapy will be designated as the intervention group, while the sham press needle acupuncture therapy will be designated as the control group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miranda Hartini Marpaung, Universitas Indonesia
- Investigators
- KPEK FKUI-RSCM, Principal investigator, the Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278284
- Sponsor's protocol ID
- 25-11-1709
- Status last verified
- Feb 2026
- First submitted
- 26 Nov 2025
- Last updated
- 7 Jul 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 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Press Needle Acupuncture on Preoperative Anxiety in Tympanoplasty and Mastoidectomy at RSUD Kabupaten Tangerang
- ClinicalTrials.gov ID
- NCT07278284
- Acronym / sponsor ID
- 25-11-1709
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 18 Jan 2026 (actual)
- Primary completion
- 8 Jun 2026 (actual)
- Study completion
- 8 Jun 2026 (actual)
- First posted
- 12 Dec 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 learn if press needle acupuncture works to treat preoperative anxiety in Tympanoplasty and Mastoidectomy at RSUD Kabupaten Tangerang in adults. The main questions it aims to answer are:
Does the press-needle acupuncture administered one day before tympanoplasty and mastoidectomy significantly reduce preoperative anxiety levels-measured using the Amsterdam Preoperative Anxiety and Information Scale (APAIS)-compared with the sham press-needle group at 30 minutes after the intervention and 60 minutes before anesthesia induction?
Is there a difference in effectiveness between press-needle acupuncture and sham press-needle acupuncture in influencing Heart Rate Variability (HRV) among patients undergoing tympanoplasty and mastoidectomy at 30 minutes after the intervention, 60 minutes before anesthesia induction, 2 hours postoperatively, and 24 hours postoperatively?
Are there any adverse events associated with the use of press-needle acupuncture and sham press-needle acupuncture in patients with preoperative anxiety undergoing tympanoplasty and mastoidectomy?
Participants will:
Receive press-needle acupuncture or sham press-needle acupuncture one day before surgery Have the press needles left in place for a total of 3 days Undergo removal of the needles before hospital discharge Complete preoperative anxiety assessments and routine monitoring according to the study schedule
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The press needle acupuncture therapy will be designated as the intervention group, while the sham press needle acupuncture therapy will be designated as the control group
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: The press needle acupuncturePress Needle Acupuncture |
| Control Group | Sham comparator | Device: The sham press needle acupunctureSham press needle acupuncture |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients diagnosed and scheduled for elective tympanoplasty and mastoidectomy under general anesthesia who experience preoperative anxiety.
- Patients aged 18-59 years.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Patients who have not taken any anti-anxiety medication within the past 24 hours.
- Willing to participate in the study until completion and sign the informed consent form.
Key exclusion criteria (5 listed)
- Patients with a history of psychiatric disorders or those taking psychotropic medications.
- Presence of contraindications to acupuncture, including medical emergencies, pregnancy, thrombocytopenia with platelet count <50,000/µL, and any history of bleeding disorders.
- Presence of infection, scarring, or malignancy at the acupuncture site.
- Anatomical abnormalities of the auricle.
- History of hypersensitivity reactions to prior acupuncture therapy (such as metal allergy, keloids, or other cutaneous hypersensitivity reactions).
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 |
|---|---|---|
| The press needle acupunctureInsertion of acupuncture needles (Pyonex, Korea) measuring 0.2 × 0.9 mm at the auricular acupuncture points Micro Acupuncture - Triangular Fossa1 (MA-TF1) Shenmen, Micro Acupuncture - Anti Tragus2 (MA-AT2) Thalamus, and Micro Acupuncture - Inferior Concha7 (MA-IC7) Heart unilaterally (on the ear opposite to the surgical side), and insertion of a 0.2 × 1.5 mm press needle at the body point Extra - Head Neck3 (EX-HN3). The needles are inserted one day before surgery, with no stimulation performed either during insertion or while the press needles remain in place. Participants are instructed not to touch the application sites until the needles are removed. | Device | Intervention Group |
| The sham press needle acupunctureApplication of round adhesive patches with a diameter resembling that of a press needle at the auricular points Micro Acupuncture - Triangular Fossa1 (MA-TF1) Shenmen, Micro Acupuncture - Anti Tragus2 (MA-AT2) Thalamus, and Micro Acupuncture - Inferior Concha7 (MA-IC7) Heart unilaterally (on the ear opposite to the surgical side), as well as at the body point Extra - Head Neck3 (EX-HN3). The patches are applied one day before surgery, with no stimulation performed either during application or while the patches remain in place. Participants are instructed not to touch the application sites until the patches are removed. | Device | Control Group |
Primary outcome
The Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Time frame: Baseline, 30 minutes post-intervention, 60 minutes before anesthesia induction
The Amsterdam Preoperative Anxiety and Information Scale (APAIS) is a questionnaire consisting of six items rated on a 5-point Likert scale. These six items are divided into three components: anxiety related to anesthesia, anxiety related to the surgical procedure, and the need-for-information component. Higher scores indicate higher levels of preoperative anxiety and a greater need for information.
Heart Rate Variability (HRV)
Time frame: Baseline, 30 minutes post-intervention, 60 minutes before anesthesia induction, 2 hours postoperatively, 24 hours postoperatively
Heart rate variability measurements using an HRV monitor (Polar H10) for 5 minutes in the seated position, with the corresponding application operated on the research assistant's smartphone.
1 secondary outcome
Side effects
Time frame: Immediately after the intervention
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 7 Jul 2026.
- Individual participant dataSharing planned: No
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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.
KPEK FKUI-RSCM principal investigator
the Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The press needle acupuncture in people with Anxiety, run by Universitas Indonesia at 1 site 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 5 inclusion and 5 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 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The Amsterdam Preoperative Anxiety and Information Scale (APAIS) (time frame: Baseline, 30 minutes post-intervention, 60 minutes before anesthesia induction). 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 7 Jul 2026.