Acupressure for Agitation, Pain, and Sleep in Mechanically Ventilated ICU Patients (CALM-ICU)

Effects of a Repeated Acupressure Program on Agitation, Pain, and Sleep in Mechanically Ventilated Intensive Care Unit Patients: A Randomized Controlled Trial

Mechanically ventilated intensive care unit (ICU) patients commonly experience agitation, pain, and sleep disturbances, which may negatively affect recovery and increase the need for sedative medications. Non-pharmacological interventions such as acupressure have been proposed as potential supportive strategies for symptom management in critically ill patients.

This randomized controlled trial aims to evaluate the effects of a repeated acupressure program on agitation, pain, and sleep in mechanically ventilated ICU patients. Participants will be randomly assigned to either an acupressure intervention group or a control group receiving light touch at the same acupoints. The intervention was administered twice daily for four consecutive days. Agitation, pain, and sleep outcomes will be assessed using both subjective and objective measurements, including wearable device-based monitoring. The study also aims to explore the cumulative effects of repeated acupressure intervention during ICU hospitalization.

Study Overview

• Status: Completed
• Conditions: Pain; Sleep Wake Disorders; Critical Illness; Agitation; Mechanical Ventilation
• Intervention / Treatment: Behavioral: Acupressure; Behavioral: Light Touch

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Changhua, Taiwan, 50006
    • Official Human Research Protection Program, Changhua Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients aged 20 years or older
• Admitted to an intensive care unit
• Receiving mechanical ventilation via an oral endotracheal tube
• Richmond Agitation-Sedation Scale (RASS) score between +2 and +3
• Expected to remain in the ICU for at least 4 consecutive days
• Able to receive acupressure intervention as determined by the clinical care team

Exclusion Criteria:

• planned extubation or ventilator weaning during the study period to ensure a stable clinical condition throughout the intervention period
• requirement for deep sedation (e.g., continuous high-dose midazolam or propofol)
• severely hemodynamic or respiratory instability (e.g., APACHE II ≥30, heart rate ≥150 beats/min with severe arrhythmia, respiratory rate ≥30 breaths/min, SpO₂ <90%, or use of high-dose vasopressors with mean arterial pressure ≤50 mmHg)
• severe agitation requiring immediate pharmacological restraint
• diagnosed delirium, psychiatric disorders, or neurocognitive disorders
• bleeding tendency (e.g., platelet count <20,000/µL) or contraindications to acupressure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupressure Group; Participants receive repeated acupressure intervention in addition to standard ICU care.	Behavioral: Acupressure; Repeated multi-acupoint acupressure administered during ICU hospitalization.
Sham Comparator: Light Touch Control Group; Participants receive light touch intervention without therapeutic acupressure effects in addition to standard ICU care.	Behavioral: Light Touch; Non-therapeutic light touch used as a sham control intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agitation level	Agitation level will be assessed using the Richmond Agitation-Sedation Scale (RASS), a 10-point scale ranging from -5 to +4. A score of -5 indicates an unarousable state, 0 indicates an alert and calm state, and +4 indicates combative behavior. Higher scores represent greater agitation, whereas lower scores represent deeper levels of sedation. All assessments will be performed by blinded bedside nurses.	Measured twice daily (morning and afternoon) before intervention, immediately after intervention, and 30 minutes after intervention for 4 consecutive days.
Pain intensity	Pain intensity will be assessed using the Critical-Care Pain Observation Tool (CPOT), which ranges from 0 to 8. Higher scores indicate greater pain intensity. All assessments will be performed by blinded bedside nurses.	Measured twice daily (morning and afternoon) before intervention, immediately after intervention, and 30 minutes after intervention for 4 consecutive days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agitation-related activity level	Agitation-related activity level will be measured using Fitbit Charge 5 wearable device monitoring.	It was continuously monitored before intervention (Day 0), daily during the intervention period (Day 1-4), and 24 hours after completion of the intervention (Day5).
the number of patients requiring additional sedatives	The number of patients requiring additional sedatives for agitation control will be recorded during the intervention period.	It was measured throughout the 4-day intervention period.
Sleep duration	Sleep duration will be measured using the Fitbit Charge 5 wearable device and recorded in hours per day.	It was continuously monitored before intervention (Day 0), daily during the intervention period (Day 1-4), and 24 hours after completion of the intervention (Day5).

Collaborators and Investigators

• Sponsor: Yang Yun Shiuan

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2023
• Primary Completion (Actual): October 5, 2024
• Study Completion (Actual): October 5, 2024

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: May 24, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: intensive care unit; Pain; Mechanical Ventilation; Sleep disturbance; Agitation
• Additional Relevant MeSH Terms: Aberrant Motor Behavior in Dementia; Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Pathologic Processes; Disease Attributes; Behavioral Symptoms; Neurobehavioral Manifestations; Dyskinesias; Psychomotor Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Pain; Parasomnias; Critical Illness; Sleep Wake Disorders; Psychomotor Agitation; Therapeutics; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Therapy, Soft Tissue; Musculoskeletal Manipulations; Acupressure
• Other Study ID Numbers: IRB230715

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No