Intensive Care Unit DeliriumNCT04312893
The Effectiveness of Acupuncture for Delirium in Critically Ill Patients
A study testing Acupuncture (Press Tack Needle) in people with Intensive Care Unit Delirium and Delirium, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Introduction: Intensive care unit (ICU) delirium is an acute onset of brain dysfunction, which can affect 25-80% of ICU patients. Delirium is also associated with long term cognition impairment, higher mortality and higher ICU costs. Previous acupuncture studies showed the potential to prevent delirium. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Intensive Care Unit Delirium, Delirium, Agitation
- What is being tested?
- Acupuncture (Press Tack Needle)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Mar 2020to 30 May 2022
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20-90
- Apache score <30
- Patients admitted in the ICU
- Positive delirium score as: 4 or more points according to the Intensive Care Delirium Screening Checklist (ICDSC)
- Richmond Agitation-Sedation Scale (RASS): +1, +2, +3, +4 -1, -2
Who cannot join
- Coagulopathy: Prolong Prothrombin Time (PPT) activated Partial Thromboplastin Time (aPTT) more than 4 times
- Thrombocytopenia - low platelet count
- Clinically unstable: receiving two inotropic agents or Fraction of Inspired Oxygen (FiO2) >70%
- Rass score: 0, -3, -4 (at the time of enrollment)
- Primary central nervous system disorder: stroke, traumatic brain injury, central nervous system infections, brain tumors, recent intracranial surgery
- Alcohol or substance withdrawal.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
medical and surgical intensive care department, medical and the surgical ward of China Medical University Hospital
Taichung, 404472
Peiyu Kao, M.D., +886910698942, ludouto@gmail.com
Eyal Ben-Arie, M.S., +886989172041, benarie19@gmail.com
About this study
Official title: The Effectiveness of Acupuncture for Delirium in Critically Ill Patients: a Double Blind Randomized Control Trial
Introduction: Intensive care unit (ICU) delirium is an acute onset of brain dysfunction, which can affect 25-80% of ICU patients. Delirium is also associated with long term cognition impairment, higher mortality and higher ICU costs. Previous acupuncture studies showed the potential to prevent delirium. This study will examine the ability of acupuncture to treat ICU delirium.
Methods: A double-blind randomized control trial will examine the effect of press tack acupuncture vs. press tack placebos. The patients will be randomly divided (1:1) into one of two groups. A total of 80 ICU patient will have to meet the following criteria: age 20-90, APACHE score <30, Intensive Care Delirium Screening Checklist (ICDSC) >4 points (indicates existing delirium), Richmond Agitation-Sedation Scale (RASS): +1, +2, +3, +4, -1, -2. Three interventions will be given in each group. The main outcomes will be the delirium days according to the ICDSC.
Read the detailed description
Introduction: Intensive care unit (ICU) delirium is an acute onset of brain dysfunction, which can affect 25-80% of ICU patients. Delirium is also associated with long term cognition impairment, higher mortality and higher ICU costs. Previous acupuncture studies showed the potential to prevent delirium. This study will examine the ability of acupuncture to treat ICU delirium.
Methods: A double-blind randomized control trial will examine the effect of press tack acupuncture vs. press tack placebos. The patients will be randomly divided (1:1) into one of two groups. A total of 80 ICU patient will have to meet the following criteria: age 20-90, APACHE score <30, Intensive Care Delirium Screening Checklist (ICDSC) >4 points (indicates existing delirium), Richmond Agitation-Sedation Scale (RASS): +1, +2, +3, +4, -1, -2. Three interventions will be given in each group. The main outcomes will be the delirium days according to the ICDSC.
Expected outcome: The study finding will help to determine the therapeutic effect of acupuncture for critically ill delirium patients. Furthermore, the study design will involve longer needle/placebos retention which is less investigated nowadays.
Other information: This study will be conducted in the ICU departments of China medical hospital, Taichung city, Taiwan. The study is conducted on stable ICU patients and we don't anticipate any serious risk for adverse events following the intervention. The study will take place until May 2022.
Keywords: acupuncture, critically ill, intensive care, delirium, agitation
- Conditions
- Intensive Care Unit Delirium, Delirium, Agitation
- Being tested
- Acupuncture (Press Tack Needle), press tack placebo
- Keywords
- Acupuncture, Critically ill, Intensive care, Delirium, Agitation
- Medical subject headings
- Delirium, Psychomotor Agitation, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture (Press Tack Needle)Other
Also called Press Tack Needle/ sticker needle/PYONEX
Press Tack Needle (PYONEX made by Seirin Corporation). The needles appear identical to the press tack placebo with the only different is the needle itself which was removed in the placebo needles.
press tack placeboOther
Also called PYONEX placebo
press tack placebo (made by Seirin Corporation), which looks identical to press tack needles but, with no needle element.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group (ACU) | Experimental | Patients in acupuncture group will receive traditional Chinese acupuncture combined with Tung's style acupuncture using Press Tack Needle (PYONEX Φ0.20×0.6 mm made by Seirin Corporation). The needles appear identical to the press tack placebo with the only different is the needle itself which was removed in the placebo needles. The following acupoints will be used: HT 7 (Shen Men), PC 6 (Nei Guan), Yin Tang (EX-HN 3), San Shang (55-02) (three point from Dong's acupuncture system) and the auricular Shen Men point. The treatment will use bilateral acupuncture (if patient's condition does not allow it, unilateral acupuncture will be done). The patient will lie in a supine position during the treatment. Acupuncturist will disinfect the acupoint location with an alcohol pad (70% alcohol), then the acupuncturist will press the needles sticker to the mentioned above acupoints. Interventions will be given on day 1, 3, and 5 after patient's enrolment. Receives: Other: Acupuncture (Press Tack Needle) |
| Control group (CON) | Placebo comparator | Patients randomized to the control group will receive press tack placebo (made by Seirin Corporation), which looks identical to press tack needles but, with no needle element. The point selection will be identical to acupuncture group: HT 7 (Shen Men), PC 6 (Nei Guan), Yin Tang (EX-HN 3), San Shang (55-02) (three point from Dong's acupuncture system) and the auricular Shen Men point. The treatment methods and patients position will be identical to acupuncture group. Interventions will be given on day 1, 3, and 5 after patient's enrolment. Receives: Other: press tack placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensive Care Delirium Screening Checklist
A common delirium examination in the intensive care unit lowest score:1 ,highest score:8 , a score of 4 or higher indicates delirium
Measured: 4 weeks
Secondary outcomes (11)
Richmond Agitation-Sedation Scale
A common scale to measure the severity on the delirium. The scale rates +4 to -4 Combative+4 Very agitated+3 Agitated+2 Restless+1 Alert and calm -0 Drowsy-1 Light sedation-2 Moderate sedation-3 Deep sedation-4
Measured: 4 weeks
mechanical ventilation in days
mechanical ventilation day is at least 5 hours under ventilator
Measured: 4 weeks
intensive care unit (ICU) stay in days
number of days a patient stays in the intensive care unit
Measured: 4 weeks
hospital stay in days
number of days a patient stays in the hospital
Measured: 4 weeks
intensive care unit (ICU) mortality
the number of patients die in the intensive care unit (ICU)
Measured: 4 weeks
hospital mortality
the number of patients die in the hospital
Measured: 4 weeks
drug use
daily dose of: sedative drugs, muscle relaxant or atypical antipsychotics
Measured: 4 weeks
Blood pressure
patients systolic and diastolic blood pressure
Measured: one hour before the interventions
heart rate
patients heart rate
Measured: one hour before the interventions
Blood pressure
patients systolic and diastolic blood pressure
Measured: one hour after the interventions
heart rate
patients heart rate
Measured: one hour after the interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start12 Mar 2020
- Primary completion30 May 2022 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intensive Care Unit DeliriumStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe 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
- two groups, randomized, pre-post intervention study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peiyu Kao, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312893
- Sponsor's protocol ID
- CMUH109-REC3-006
- Status last verified
- Aug 2021
- First submitted
- 13 Mar 2020
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kao PY, Ben-Arie E, Wei TH, Bernice L, Ho WC, Lee YC, Chen FP. Investigating press tack needle treatment for delirium in critically ill patients: A double-blind randomized sham-controlled pilot trial. J Psychiatr Res. 2025 Sep;189:9-17. doi: 10.1016/j.jpsychires.2025.05.071. Epub 2025 May 28.
PubMed 40466557
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Acupuncture for Delirium in Critically Ill Patients: a Double Blind Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04312893
- Acronym / sponsor ID
- CMUH109-REC3-006
- Conditions
- Intensive Care Unit Delirium, Delirium, Agitation
- Keywords
- Acupuncture, Critically ill, Intensive care, Delirium, Agitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 18 Mar 2020 (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.
Introduction: Intensive care unit (ICU) delirium is an acute onset of brain dysfunction, which can affect 25-80% of ICU patients. Delirium is also associated with long term cognition impairment, higher mortality and higher ICU costs. Previous acupuncture studies showed the potential to prevent delirium. This study will examine the ability of acupuncture to treat ICU delirium.
Methods: A double-blind randomized control trial will examine the effect of press tack acupuncture vs. press tack placebos. The patients will be randomly divided (1:1) into one of two groups. A total of 80 ICU patient will have to meet the following criteria: age 20-90, APACHE score <30, Intensive Care Delirium Screening Checklist (ICDSC) >4 points (indicates existing delirium), Richmond Agitation-Sedation Scale (RASS): +1, +2, +3, +4, -1, -2. Three interventions will be given in each group. The main outcomes will be the delirium days according to the ICDSC.
Detailed description
Introduction: Intensive care unit (ICU) delirium is an acute onset of brain dysfunction, which can affect 25-80% of ICU patients. Delirium is also associated with long term cognition impairment, higher mortality and higher ICU costs. Previous acupuncture studies showed the potential to prevent delirium. This study will examine the ability of acupuncture to treat ICU delirium.
Methods: A double-blind randomized control trial will examine the effect of press tack acupuncture vs. press tack placebos. The patients will be randomly divided (1:1) into one of two groups. A total of 80 ICU patient will have to meet the following criteria: age 20-90, APACHE score <30, Intensive Care Delirium Screening Checklist (ICDSC) >4 points (indicates existing delirium), Richmond Agitation-Sedation Scale (RASS): +1, +2, +3, +4, -1, -2. Three interventions will be given in each group. The main outcomes will be the delirium days according to the ICDSC.
Expected outcome: The study finding will help to determine the therapeutic effect of acupuncture for critically ill delirium patients. Furthermore, the study design will involve longer needle/placebos retention which is less investigated nowadays.
Other information: This study will be conducted in the ICU departments of China medical hospital, Taichung city, Taiwan. The study is conducted on stable ICU patients and we don't anticipate any serious risk for adverse events following the intervention. The study will take place until May 2022.
Keywords: acupuncture, critically ill, intensive care, delirium, agitation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- two groups, randomized, pre-post intervention study
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group (ACU) | Experimental | Other: Acupuncture (Press Tack Needle)Patients in acupuncture group will receive traditional Chinese acupuncture combined with Tung's style acupuncture using Press Tack Needle (PYONEX Φ0.20×0.6 mm made by Seirin Corporation). The needles appear identical to the press tack placebo with the only different is the needle itself which was removed in the placebo needles. The following acupoints will be used: HT 7 (Shen Men), PC 6 (Nei Guan), Yin Tang (EX-HN 3), San Shang (55-02) (three point from Dong's acupuncture system) and the auricular Shen Men point. The treatment will use bilateral acupuncture (if patient's condition does not allow it, unilateral acupuncture will be done). The patient will lie in a supine position during the treatment. Acupuncturist will disinfect the acupoint location with an alcohol pad (70% alcohol), then the acupuncturist will press the needles sticker to the mentioned above acupoints. Interventions will be given on day 1, 3, and 5 after patient's enrolment. |
| Control group (CON) | Placebo comparator | Other: press tack placeboPatients randomized to the control group will receive press tack placebo (made by Seirin Corporation), which looks identical to press tack needles but, with no needle element. The point selection will be identical to acupuncture group: HT 7 (Shen Men), PC 6 (Nei Guan), Yin Tang (EX-HN 3), San Shang (55-02) (three point from Dong's acupuncture system) and the auricular Shen Men point. The treatment methods and patients position will be identical to acupuncture group. Interventions will be given on day 1, 3, and 5 after patient's enrolment. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 20-90
- Apache score <30
- Patients admitted in the ICU
- Positive delirium score as: 4 or more points according to the Intensive Care Delirium Screening Checklist (ICDSC)
- Richmond Agitation-Sedation Scale (RASS): +1, +2, +3, +4 -1, -2
Key exclusion criteria (6 listed)
- Coagulopathy: Prolong Prothrombin Time (PPT) activated Partial Thromboplastin Time (aPTT) more than 4 times
- Thrombocytopenia - low platelet count
- Clinically unstable: receiving two inotropic agents or Fraction of Inspired Oxygen (FiO2) >70%
- Rass score: 0, -3, -4 (at the time of enrollment)
- Primary central nervous system disorder: stroke, traumatic brain injury, central nervous system infections, brain tumors, recent intracranial surgery
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 |
|---|---|---|
| Acupuncture (Press Tack Needle)Also: Press Tack Needle/ sticker needle/PYONEXPress Tack Needle (PYONEX made by Seirin Corporation). The needles appear identical to the press tack placebo with the only different is the needle itself which was removed in the placebo needles. | Other | Acupuncture group (ACU) |
| press tack placeboAlso: PYONEX placebopress tack placebo (made by Seirin Corporation), which looks identical to press tack needles but, with no needle element. | Other | Control group (CON) |
Primary outcome
Intensive Care Delirium Screening Checklist
Time frame: 4 weeks
A common delirium examination in the intensive care unit lowest score:1 ,highest score:8 , a score of 4 or higher indicates delirium
11 secondary outcomes
Richmond Agitation-Sedation Scale
Time frame: 4 weeks
mechanical ventilation in days
Time frame: 4 weeks
intensive care unit (ICU) stay in days
Time frame: 4 weeks
hospital stay in days
Time frame: 4 weeks
intensive care unit (ICU) mortality
Time frame: 4 weeks
hospital mortality
Time frame: 4 weeks
drug use
Time frame: 4 weeks
Blood pressure
Time frame: one hour before the interventions
heart rate
Time frame: one hour before the interventions
Blood pressure
Time frame: one hour after the interventions
heart rate
Time frame: one hour after the interventions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Derived from this study: PubMed 40466557Kao PY, Ben-Arie E, Wei TH, Bernice L, Ho WC, Lee YC, Chen FP. Investigating press tack needle treatment for delirium in critically ill patients: A double-blind randomized sham-controlled pilot trial. J Psychiatr Res. 2025 Sep;189:9-17. doi: 10.1016/j.jpsychires.2025.05.071. Epub 2025 May 28.
- Individual participant dataSharing planned: No
Related trials for Intensive Care Unit Delirium
Not yet recruiting
Family-partnered Delirium Prevention, Detection, and Management in the ICU
Delirium, Intensive Care Unit Delirium
Recruiting
Behavioral Economic & Staffing Strategies in the ICU
Implementation Science, Delirium
Not yet recruitingEarly Phase 1
reALIGNing Circadian Rhythm and Promoting Sleep in the Intensive Care Unit
Sleep, Circadian Dysregulation
Not yet recruitingEarly Phase 1
Reducing Days DELirious With DEXmedetomidine as Part of an Intensive Care Unit Sleep Promotion Bundle
Sleep, Delirium
RecruitingPhase 4
Lemborexant for Sleep and Delirium Prevention in Elderly ICU Patients
Sleep Disturbance, Delirium
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.
medical and surgical intensive care department, medical and the surgical ward of China Medical University Hospital
Taichung, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture (Press Tack Needle) in people with Intensive Care Unit Delirium and Delirium, run by China Medical University Hospital at 1 site in Taiwan.
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 6 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 3 Aug 2021. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensive Care Delirium Screening Checklist (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04312893, which also lists 1 linked publication.
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 3 Aug 2021.