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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230202057303N3
Enrollment
74
Registered
2024-04-19
Start date
2024-04-29
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

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

Interventions

Intervention 1: Intervention group: Foot Reflexology Massage- foot massage includes the steps of preparation, heating and relaxation. In the preparation phase, all children will be given towels and sh

Sponsors

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

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

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

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)

Design outcomes

Primary

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

Secondary

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

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMona Alinejad-Naeini

Iran University of Medical Sciences

alinejad.m@iums.ac.ir+98 21 4365 1605

Outcome results

None listed

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