Post CraniotomyNCT06808256
Effect of Acupuncture on Hemodynamics and Pain of Post Craniotomy Patients With Mechanical Ventilation
A study testing the acupuncture therapy and Standard therapy in people with Post Craniotomy, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The aim of this clinical trial is to prove that acupuncture therapy combined with standard therapy can optimize hemodynamics and reduce pain in post-craniotomy patients with mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Craniotomy
- What is being tested?
- the acupuncture therapy and Standard therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Mar 2025to 1 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female over 18 years old
- Subjects who received craniotomy with vascular etiology
- Conscious patients with GCS over 9 before craniotomy
- Using SIMV mode mechanical ventilation
- Family willing for the patient to participate in the study until completion and signed informed consent
Who cannot join
- History of neuromusculoskeletal diseases such as myasthenia gravis or multiple sclerosis
- Treatment for lung cancer and COVID-19
- There is infection, scarring or malignancy in the acupuncture stabbing area
- Patients with blood clotting disorders, platelets under 50. 000/µl, patients on anticoagulant therapy with INR over 2.0
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Acupuncture on Hemodynamics and Pain of Post Craniotomy Patients With Mechanical Ventilation in the ICU of Tangerang Regency Hospital Banten
The aim of this clinical trial is to prove that acupuncture therapy combined with standard therapy can optimize hemodynamics and reduce pain in post-craniotomy patients with mechanical ventilation. The main questions it aims to answer are:
- Is there a difference in mean arterial pressure, pulse rate, respiratory rate, oxygen fraction and pain in the acupuncture therapy group combined with standard therapy compared to standard therapy after the 3rd therapy and compared to before therapy?
- Is there a difference in changes in ventilator mode in the acupuncture therapy group combined with standard therapy compared to standard therapy after the 3rd therapy?
- Are there any side effects in the acupuncture therapy group combined with standard therapy?
Read more
Researchers will compare acupuncture therapy combined with standard therapy to standard therapy only
Participants will:
- receive acupuncture therapy for 3 consecutive days
- outcomes will be assessed after 3 days of therapy.
Read the detailed description
- Standard therapy is pharmacological therapy administered by the patient's attending anesthesiologist to research subjects in accordance with existing clinical practice guidelines. At the ICU of Tangerang District General Hospital, standard therapy administered to patients post-craniotomy with mechanical ventilation includes symptomatic therapy based on the patient's symptoms and condition (including antihypertensive medications, typically calcium channel blockers administered intravenously or orally), analgesics (typically fentanyl or morphine), and sedation (midazolam or propofol). This standard therapy is also administered according to the patient's clinical condition.
- Hemodynamic refers to parameters assess whether perfusion in the body is adequate or not, including how the heart pumps blood, how blood vessels carry blood throughout the body, and how blood nourishes and supplies oxygen to body tissues. Hemodynamic outcomes are assessed through vital signs such as blood pressure or Mean Arterial Pressure, pulse rate, respiratory rate, and oxygen requirements (FiO2).
- Critical Care Pain Observation Tools (CPOT) is a pain assessment tool for patients who are unable to communicate verbally and are on a ventilator. The assessment includes facial expressions, body movements, muscle tension, and compliance with the ventilator.
- Conditions
- Post Craniotomy
- Being tested
- the acupuncture therapy, Standard therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the acupuncture therapyProcedure or surgery
Acupuncture is performed for 3 consecutive days, using filiform needles in the chest, hands, feet area with 20 minutes retention during therapy and using press needle on the forehead which are retained for 3 days and after 3 days the stick needles will be removed. And patient continue to receive standard therapy in accordance with the clinical practice guidelines of the ICU Tangerang Hospital
Standard therapyOther
Pharmacological therapy provided by the doctor in charge of anesthesia science patients to the research subjects was in accordance with existing clinical practice guidelines. In the ICU of Tangerang Hospital, the standard therapy given to post-craniotomy patients with mechanical ventilation is analgesic and sedation. This standard therapy is also given according to the patient's clinical condition
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The acupuncture and standard therapy Receives: Procedure: the acupuncture therapy; Other: Standard therapy |
| Control Group | Active comparator | Standard therapy only Receives: Other: Standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Arterial Pressure
Average arterial pressure during one cardiac cycle of systole and diastole
Measured: Before therapy, Day 4
Heart Rate
Measurement of the participant's pulse rate over one minute.
Measured: Before therapy, Day 4
Respiration Rate
Measurement of the participant's respiratory rate over one minute.
Measured: Before therapy, Day 4
Oxygen Fraction
Oxygen concentration in the inhaled gas mixture, as displayed on the patient monitor.
Measured: Before therapy, Day 4
Critical care Pain Observation Tools
Pain assessment in non-verbal and mechanically ventilated patients, including facial expressions, body movements, muscle tension, and compliance.
Measured: Before therapy, Day 4
Secondary outcomes (2)
Ventilator Mode
Changes in the type of ventilator settings used for the participant.
Measured: Day 4
Side Effect
Patient-reported complaints after receiving manual acupuncture therapy.
Measured: Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start1 Mar 2025
- Primary completion30 Apr 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post CraniotomyStudies 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 acupuncture therapy combined with standard therapy will be designated as the intervention group, while the standard therapy only will be designated as the control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zellah Fransisca Natalia, Universitas Indonesia
- Investigators
- KPEK FKUI-RSCM, Principal investigator, the Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808256
- Sponsor's protocol ID
- 24-12-1830
- Status last verified
- Jul 2025
- First submitted
- 3 Feb 2025
- Last updated
- 14 Jul 2025
- 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 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupuncture on Hemodynamics and Pain of Post Craniotomy Patients With Mechanical Ventilation in the ICU of Tangerang Regency Hospital Banten
- ClinicalTrials.gov ID
- NCT06808256
- Acronym / sponsor ID
- 24-12-1830
- Conditions
- Post Craniotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 5 Feb 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 aim of this clinical trial is to prove that acupuncture therapy combined with standard therapy can optimize hemodynamics and reduce pain in post-craniotomy patients with mechanical ventilation. The main questions it aims to answer are:
- Is there a difference in mean arterial pressure, pulse rate, respiratory rate, oxygen fraction and pain in the acupuncture therapy group combined with standard therapy compared to standard therapy after the 3rd therapy and compared to before therapy?
- Is there a difference in changes in ventilator mode in the acupuncture therapy group combined with standard therapy compared to standard therapy after the 3rd therapy?
- Are there any side effects in the acupuncture therapy group combined with standard therapy?
Researchers will compare acupuncture therapy combined with standard therapy to standard therapy only
Participants will:
- receive acupuncture therapy for 3 consecutive days
- outcomes will be assessed after 3 days of therapy.
Detailed description
- Standard therapy is pharmacological therapy administered by the patient's attending anesthesiologist to research subjects in accordance with existing clinical practice guidelines. At the ICU of Tangerang District General Hospital, standard therapy administered to patients post-craniotomy with mechanical ventilation includes symptomatic therapy based on the patient's symptoms and condition (including antihypertensive medications, typically calcium channel blockers administered intravenously or orally), analgesics (typically fentanyl or morphine), and sedation (midazolam or propofol). This standard therapy is also administered according to the patient's clinical condition.
- Hemodynamic refers to parameters assess whether perfusion in the body is adequate or not, including how the heart pumps blood, how blood vessels carry blood throughout the body, and how blood nourishes and supplies oxygen to body tissues. Hemodynamic outcomes are assessed through vital signs such as blood pressure or Mean Arterial Pressure, pulse rate, respiratory rate, and oxygen requirements (FiO2).
- Critical Care Pain Observation Tools (CPOT) is a pain assessment tool for patients who are unable to communicate verbally and are on a ventilator. The assessment includes facial expressions, body movements, muscle tension, and compliance with the ventilator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The acupuncture therapy combined with standard therapy will be designated as the intervention group, while the standard therapy only will be designated as the control group
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Procedure: the acupuncture therapy, Other: Standard therapyThe acupuncture and standard therapy |
| Control Group | Active comparator | Other: Standard therapyStandard therapy only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female over 18 years old
- Subjects who received craniotomy with vascular etiology
- Conscious patients with GCS over 9 before craniotomy
- Using SIMV mode mechanical ventilation
- Family willing for the patient to participate in the study until completion and signed informed consent
Key exclusion criteria (4 listed)
- History of neuromusculoskeletal diseases such as myasthenia gravis or multiple sclerosis
- Treatment for lung cancer and COVID-19
- There is infection, scarring or malignancy in the acupuncture stabbing area
- Patients with blood clotting disorders, platelets under 50. 000/µl, patients on anticoagulant therapy with INR over 2.0
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 acupuncture therapyAcupuncture is performed for 3 consecutive days, using filiform needles in the chest, hands, feet area with 20 minutes retention during therapy and using press needle on the forehead which are retained for 3 days and after 3 days the stick needles will be removed. And patient continue to receive standard therapy in accordance with the clinical practice guidelines of the ICU Tangerang Hospital | Procedure or surgery | Intervention Group |
| Standard therapyPharmacological therapy provided by the doctor in charge of anesthesia science patients to the research subjects was in accordance with existing clinical practice guidelines. In the ICU of Tangerang Hospital, the standard therapy given to post-craniotomy patients with mechanical ventilation is analgesic and sedation. This standard therapy is also given according to the patient's clinical condition | Other | Control Group, Intervention Group |
Primary outcome
Mean Arterial Pressure
Time frame: Before therapy, Day 4
Average arterial pressure during one cardiac cycle of systole and diastole
Heart Rate
Time frame: Before therapy, Day 4
Measurement of the participant's pulse rate over one minute.
Respiration Rate
Time frame: Before therapy, Day 4
Measurement of the participant's respiratory rate over one minute.
Oxygen Fraction
Time frame: Before therapy, Day 4
Oxygen concentration in the inhaled gas mixture, as displayed on the patient monitor.
Critical care Pain Observation Tools
Time frame: Before therapy, Day 4
Pain assessment in non-verbal and mechanically ventilated patients, including facial expressions, body movements, muscle tension, and compliance.
2 secondary outcomes
Ventilator Mode
Time frame: Day 4
Side Effect
Time frame: Day 4
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 14 Jul 2025.
- 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
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 acupuncture therapy and Standard therapy in people with Post Craniotomy, 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 4 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 14 Jul 2025. 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. 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?
Mean Arterial Pressure (time frame: Before therapy, Day 4). The study lists 5 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 14 Jul 2025.