The effect of Foot Reflexology Massage on Delirium and Physiological Indicators in Children Admitted to Pediatric Intensive Care Unit: A randomized clinical trial

Not Applicable

Recruiting

Conditions: Delirium, not induced by alcohol and other psychoactive substances
Delirium.

Registration Number: IRCT20230202057303N3

Lead Sponsor: Deputy of research and technology of Iran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 74

Inclusion Criteria

Failure to score 4- and 5- on the Richmond Agitation Scale
Age 6-12 years old
Hospitalization in the pediatric intensive care unit for at least 3 days
Absence of abnormalities such as corns, wounds, previous scars, burns, amputations, and skin diseases on the legs.
Absence of vascular injuries in the lower limbs and absence of sensory-motor disorders (confirmed by a neurologist) in the legs
Diagnosis of delirium by obtaining a delirium score of 9 and above based on the Cornell scale and a pediatric neurologist
No previous experience of foot reflexology massage before the study
Confirmation of the doctor's diagnosis by a pediatric specialist

Exclusion Criteria

Mechanical ventilation
Taking a X Ray and performing an invasive procedure due to the occurrence of restlessness and disturbance in the massage
Children's restlessness
Lack of proper cooperation and resistance of the child and his parents at any time of the study
Emergency conditions such as cardiopulmonary resuscitation or seizures
Child suffering from acute heart or respiratory diseases
Reduction of vital signs more than expected, such as: drop in blood pressure (below 25th percentile) and bradycardia (below 65 beats per minute)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Delirium. Timepoint: 5 minutes before the intervention - immediately after the intervention. Method of measurement: Cornell Assessment of Pediatric Delirium (CAPD).

Secondary Outcome Measures

Name	Time	Method
Physiological Indicators. Timepoint: 5 minutes before the intervention - immediately after the intervention. Method of measurement: Monitoring connected to the child.