The Effectiveness of Acupuncture for Delirium in Critically Ill Patients

NCT04312893 | Unknown

• 1 other identifier: CMUH109-REC3-006
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Intensive Care Unit Delirium; Delirium; Agitation

Keywords

Acupuncture; Critically ill; Intensive care; Delirium; Agitation

Outcome Measures

Primary Outcomes (1)

• 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

  4 weeks

Secondary Outcomes (11)

• Richmond Agitation-Sedation Scale

  4 weeks

• mechanical ventilation in days

  4 weeks

• intensive care unit (ICU) stay in days

  4 weeks

• hospital stay in days

  4 weeks

• intensive care unit (ICU) mortality

  4 weeks

Study Arms (2)

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.

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.

Other: press tack placebo

Interventions

Acupuncture (Press Tack Needle) OTHER

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.

Also known as: Press Tack Needle/ sticker needle/PYONEX

Acupuncture group (ACU)

press tack placebo OTHER

press tack placebo (made by Seirin Corporation), which looks identical to press tack needles but, with no needle element.

Also known as: PYONEX placebo

Control group (CON)

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

medical and surgical intensive care department, medical and the surgical ward of China Medical University Hospital

Taichung, 404472, Taiwan

RECRUITING

Related Publications (1)

• 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.

  PMID: 40466557 DERIVED

MeSH Terms

Conditions

Delirium; Psychomotor Agitation; Critical Illness

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Psychomotor Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Our study goal is the measure the effectiveness of press tack needles (acupuncture group) in reducing delirium severity in critically ill patients in the ICU. In order to ensure a double bind procedure, we will implement the use of press tack placebos (control group) as a competitor. In addition to the mentioned above interventions, patients in both groups will receive routine ICU care as per individual patient's needs.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: two groups, randomized, pre-post intervention study

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 18, 2020
• Study Start: March 12, 2020
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: August 3, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)