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Effectiveness of a Self-Regulation Program Using iPad-Assisted Communication in Intubated Patients with Respiratory Failure: A Randomized Controlled Trial

Effectiveness of a Self-Regulation Program Using iPad-Assisted Communication in Intubated Patients with Respiratory Failure: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251119002
Enrollment
60
Registered
2025-11-19
Start date
2024-04-02
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory failure in mechanically ventilated and intubated patients during ventilator weaning Respiratory failure Mechanical ventilation Ventilator weaning Self-regulation iPad-assisted communication Anxiety Critical care Patient participation Nursing intervention Randomized controlled trial

Interventions

Participants in the intervention group received the Self-Regulation with iPad Use Program SRIUP developed by the principal investigator based on self-regulation theory and aligned with the three phase
Experimental Behavioral,No Intervention Behavioral
Self Regulation Program with iPad Assisted Communication,Standard Intensive Care Unit Care

Sponsors

Faculty of Nursing, Rattana Bundit University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age 18 years or older, 2. Diagnosed with respiratory failure requiring intubation, 3. On mechanical ventilation for at least 24 hours but not more than 7 days, 4. Assessed by physician as ready to begin T piece weaning, 5. No previous experience with ventilator weaning, 6. Conscious and oriented, 7. Stable vital signs including heart rate 50 to 120 beats per minute, respiratory rate less than 30 breaths per minute, systolic blood pressure 90 to 180 mmHg, diastolic blood pressure 60 to 110 mmHg, and oxygen saturation at least 90 percent or partial pressure of oxygen greater than 60 mmHg, 8. No vasodilator use or receiving only low dose administration, 9. Not receiving continuous intravenous sedation such as fentanyl, midazolam, or cisatracurium besylate, 10. Motor power score of 4 or higher and literate in Thai language, 11. No visual or auditory impairment, 12. Able to nod and read printed text in Angsana New 20 point font from a distance of 1 to 2 feet

Exclusion criteria

Exclusion criteria: 1. Active COVID-19 infection or tuberculosis during the contagious phase, 2. Diagnosis of Parkinson's disease, circulatory disorders, or schizophrenia

Design outcomes

Primary

MeasureTime frame
Anxiety level Baseline (before intervention) and 2 hours after intervention State-Trait Anxiety Inventory 20-item questionnaire with scores ranging from 20 to 80 higher scores indicate greater anxiety

Secondary

MeasureTime frame
Perceived fulfillment of care needs Baseline (before intervention) and 2 hours after intervention 30 item questionnaire developed based on Petro Yura and Walsh framework 5 point Likert scale higher scores indicate higher perceived fulfillment,Ventilator weaning success 48 hours post-extubation Successful extubation defined as maintaining spontaneous breathing without reintubation within 48 hours

Countries

Thailand

Contacts

Public ContactNuttapol Chaihan

Faculty of Nursing, Rattana Bundit University

nuttapol.chaihan@gmail.com0958275430

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026