Skip to main content
OpenTrials
Completed

NCT Number: NCT07619326

Acupressure for Agitation, Pain, and Sleep in Mechanically Ventilated ICU Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mechanical Ventilation Aberrant Motor Behavior in Dementia Agitation Behavior Behavioral Symptoms Critical Illness Disease Attributes Dyskinesias Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Parasomnias Pathologic Processes Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Signs and Symptoms Sleep Wake Disorders

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Official Human Research Protection Program, Changhua Christian Hospital

Changhua, 50006, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acupressure

Behavioral

Repeated multi-acupoint acupressure administered during ICU hospitalization.

Light Touch

Behavioral

Non-therapeutic light touch used as a sham control intervention.

Primary outcomes

  1. Agitation level

    Time frame: Measured twice daily (morning and afternoon) before intervention, immediately after intervention, and 30 minutes after intervention for 4 consecutive days.

    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.

  2. Pain intensity

    Time frame: Measured twice daily (morning and afternoon) before intervention, immediately after intervention, and 30 minutes after intervention for 4 consecutive days.

    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.

Secondary outcomes

  1. Agitation-related activity level

    Time frame: 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).

    Agitation-related activity level will be measured using Fitbit Charge 5 wearable device monitoring.

  2. Sleep duration

    Time frame: 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).

    Sleep duration will be measured using the Fitbit Charge 5 wearable device and recorded in hours per day.

  3. the number of patients requiring additional sedatives

    Time frame: It was measured throughout the 4-day intervention period.

    The number of patients requiring additional sedatives for agitation control will be recorded during the intervention period.

Sponsors and collaborators

Lead sponsor

Yang Yun Shiuan

Other

Registry information

Official study title

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

Acronym: CALM-ICU

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 2, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.