Agitation, Critical Illness, Mechanical Ventilation, Pain, Sleep Wake Disorders
Conditions
Keywords
Mechanical Ventilation, intensive care unit, Agitation, Pain, Sleep disturbance
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.
Interventions
BEHAVIORALAcupressure
Repeated multi-acupoint acupressure administered during ICU hospitalization.
BEHAVIORALLight Touch
Non-therapeutic light touch used as a sham control intervention.
Sponsors
Yang Yun Shiuan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agitation level | 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. |
| Pain intensity | 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
| Measure | Time frame | Description |
|---|---|---|
| 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). | Agitation-related activity level will be measured using Fitbit Charge 5 wearable device monitoring. |
| 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). | Sleep duration will be measured using the Fitbit Charge 5 wearable device and recorded in hours per day. |
| the number of patients requiring additional sedatives | 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. |
Countries
Taiwan
Outcome results
None listed