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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupressure Group | Experimental | Participants receive repeated acupressure intervention in addition to standard ICU care. |
|
| Light Touch Control Group | Sham Comparator | Participants receive light touch intervention without therapeutic acupressure effects in addition to standard ICU care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupressure | Behavioral | Repeated multi-acupoint acupressure administered during ICU hospitalization. |
|
| 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. |
| 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). |
| Sleep duration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Official Human Research Protection Program, Changhua Christian Hospital | Changhua | 50006 | Taiwan |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D011595 | Psychomotor Agitation |
| D010146 | Pain |
| D012893 | Sleep Wake Disorders |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020820 | Dyskinesias |
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| ID | Term |
|---|---|
| D019050 | Acupressure |
| ID | Term |
|---|---|
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Light Touch | Behavioral | Non-therapeutic light touch used as a sham control intervention. |
|
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). |
| 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. |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011596 | Psychomotor Disorders |
| D019954 | Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |