Acupressure for Agitation, Pain, and Sleep in Mechanically Ventilated ICU Patients (NCT07619326) | Clinical Trial Compass
CompletedNot Applicable
Acupressure for Agitation, Pain, and Sleep in Mechanically Ventilated ICU Patients
Taiwan60 participantsStarted 2023-10-06
Plain-language 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.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested acupressure — a hands-on pressure technique — on ICU patients who were on a breathing machine; could acupressure realistically be added alongside my loved one's current sedation and pain medications, or would it interfere with their care?
2Since this trial is listed as completed, has the data been published yet, and if so, what did the results show about whether acupressure actually reduced agitation and pain in ventilated patients?
3This study is listed as Phase NA, meaning it's more of a feasibility or exploratory study rather than a large confirmatory trial — does that mean the evidence is still too early to influence my loved one's treatment plan?
4The trial also looked at sleep disturbances in ICU patients, which I know is a serious problem — are there any findings from this study, or other evidence, that you'd consider when trying to improve my loved one's sleep while they're on the ventilator?
5Compared to the standard medications used to manage agitation and pain in the ICU, what would be the practical advantages or limitations of adding something like acupressure, and is it something your ICU team has any experience with?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Agitation level
Timeframe: Measured twice daily (morning and afternoon) before intervention, immediately after intervention, and 30 minutes after intervention for 4 consecutive days.
2
Pain intensity
Timeframe: Measured twice daily (morning and afternoon) before intervention, immediately after intervention, and 30 minutes after intervention for 4 consecutive days.