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

NCT07619326 | Completed

• 1 other identifier: IRB230715
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mechanical Ventilation; Critical Illness; Agitation; Pain; Sleep Wake Disorders

Keywords

Mechanical Ventilation; intensive care unit; Agitation; Pain; Sleep disturbance

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Agitation-related activity level

  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

  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

  It was measured throughout the 4-day intervention period.

Study Arms (2)

Acupressure Group

EXPERIMENTAL

Participants receive repeated acupressure intervention in addition to standard ICU care.

Behavioral: Acupressure

Light Touch Control Group

SHAM COMPARATOR

Participants receive light touch intervention without therapeutic acupressure effects in addition to standard ICU care.

Behavioral: Light Touch

Interventions

Acupressure BEHAVIORAL

Repeated multi-acupoint acupressure administered during ICU hospitalization.

Acupressure Group

Light Touch BEHAVIORAL

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

Light Touch Control Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yang Yun Shiuan: lead

Study Sites (1)

Official Human Research Protection Program, Changhua Christian Hospital

Changhua, 50006, Taiwan

Location

MeSH Terms

Conditions

Critical Illness; Psychomotor Agitation; Pain; Sleep Wake Disorders; Parasomnias

Interventions

Acupressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Nurse

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 2, 2026
• Study Start: October 6, 2023
• Primary Completion: October 5, 2024
• Study Completion: October 5, 2024
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)