Skip to content

Comparison of the effect of two upper limb physical restraint type on the clinical outcomes of children under mechanical ventilation

Comparison of the effect of two upper limb physical restraint type on the clinical outcomes of children under mechanical ventilation: A crossover randomized clinical trial study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200818048448N2
Enrollment
48
Registered
2022-06-08
Start date
2022-06-15
Completion date
Unknown
Last updated
2022-06-27

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

Conditions

agitation sedation level.

Interventions

Intervention 1: Intervention group: For group A, first wrist restraint will be done for two hours and then elbow restraint will be done for two hours. Due to the physical restraint performed routinely

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 5 Years

Inclusion criteria

Inclusion criteria: Children aged 1 to 5 years Being hospitalized in the pediatric intensive care unit Being under mechanical ventilation Physician order to use physical restraint in the upper limb The consent of the child's parents

Exclusion criteria

Exclusion criteria: Existence of intra venous line in both upper limbs Instability of the child's physiological condition before the intervention Children with hemiplegia, extensive hematoma, history of surgery or trauma in the restrained limb Children with casts or splints in restrained limbs

Design outcomes

Primary

MeasureTime frame
Erythema. Timepoint: Measurements before the intervention will be reviewed and recorded after the initial cleansing period and before the intervention begins. Measurement during the intervention will be done one hour after the start of the intervention and measurement after the intervention will be performed immediately after the end of the two hours of the intervention. Method of measurement: clinician erythema assessment.;Edema of the hand. Timepoint: Measurements before the intervention will be reviewed and recorded after the initial cleansing period and before the intervention begins. Measurement during the intervention will be done one hour after the start of the intervention and measurement after the intervention will be performed immediately after the end of the two hours of the intervention. Method of measurement: Figure-of-Eight Method of Measuring Hand.;Palm temperature. Timepoint: Measurements before the intervention will be reviewed and recorded after the initial cleansing period and before the intervention begins. Measurement during the intervention will be done one hour after the start of the intervention and measurement after the intervention will be performed immediately after the end of the two hours of the intervention. Method of measurement: Digital thermometer.;Radial pulse. Timepoint: Measurements before the intervention will be reviewed and recorded after the initial cleansing period and before the intervention begins. Measurement during the intervention will be done one hour after the start of the intervention and measurement after the intervention will be performed immediately after the end of the two hours of the intervention. Method of measurement: Manually count the number of radial pulses per minute.;Agitation and sedation. Timepoint: Measurements before the intervention will be reviewed and recorded after the initial cleansing period and before the intervention begins. Measurement during the intervention will be done one hour after the s

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahni Rahkar Farshi

Tabriz University of Medical Sciences

rahkarfarshim@tbzmed.ac.ir+98 41 3479 6770

Outcome results

None listed

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