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The effect of implementing a non-pharmacological care package on the prevention of physical restraint and restlessness indicators of patients under mechanical ventilation

The effect of implementing a non-pharmacological care package on the prevention of physical restraint and restlessness indicators of patients under mechanical ventilation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241216064078N1
Enrollment
92
Registered
2025-02-20
Start date
2025-04-09
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Condition 1: Physical restraint. Condition 2: Delirium. Condition 3: Non-pharmaceutical care package. Condition 4: Restlessness. Condition 5: Patients undergoing mechanical ventilation. Mental and behavioural disorders due to use of sedatives or hypnotics Other specified extrapyramidal and movement disorders

Interventions

Intervention group: Patients undergoing mechanical ventilation in the intensive care unit who met the inclusion criteria for the study.

Sponsors

Bagheiat-allah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Patients undergoing mechanical ventilation over 18 and under 70 years of age Not having alcohol or drug addiction 3) No visual and hearing disorders in target patients Absence of movement disorders before hospital admission in target patients Absence of restlessness and delirium in patients before mechanical ventilation Availability of family members to participate in the study if desired Absence of mental health problems or a history of mental illness or cognitive problems

Exclusion criteria

Exclusion criteria: 1) Any continuous infusion of sedatives or muscle relaxants via an infusion pump 2) Obtaining a score of minus 3 to minus 5 on the RASS scale according to clinical assessment and medical and nursing reports 3) Death of the patients studied during the study 4) The occurrence of severe disorders such as shock, bleeding, or brain injuries during the study

Design outcomes

Primary

MeasureTime frame
Duration of physical restraint. Timepoint: At the beginning of endotracheal intubation and 6 hours after the effects of anesthetic drugs wear off and on the second and third days after implementing a non-pharmacological care package. Method of measurement: Hours of physical restraint.;Restlessness. Timepoint: At the beginning of endotracheal intubation and 6 hours after the effects of anesthetic drugs wear off and on the second and third days after implementing a non-pharmacological care package. Method of measurement: Based on RASS criteria.;Delirium. Timepoint: At the beginning of endotracheal intubation and 6 hours after the effects of anesthetic drugs wear off and on the second and third days after implementing a non-pharmacological care package. Method of measurement: Presence of delirium according to CAM ICU criteria.

Secondary

MeasureTime frame
Duration of mechanical ventilation. Timepoint: After endotracheal intubation and during the study. Method of measurement: By the hour.;Use of benzodiazepines and painkillers. Timepoint: During the study and 6 hours after endotracheal intubation. Method of measurement: Yes or no.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Maliheh Al-Sadat Moyed

Bagheiat-allah University of Medical Sciences

msmoayed@gmail.com+98 21 3852 9613

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026