The effect of Foot Reflexology Massage on Delirium and Physiological Indicators in Children Admitted to Pediatric Intensive Care Unit: A randomized clinical trial
Determining the effect of foot reflexology massage on delirium and physiological indicators in children admitted to the pediatric intensive care unit.
Design
The research is a randomized clinical trial with a control and test group, which is conducted on 74 children in PICU. Computerized randomization (www.randomizer.org) will be used.
Settings and conduct
This research will be done in Hazrat Ali Asghar hospital. Sampling will be done continuously and based on the study inclusion criteria. Using computer randomization (www.randomizer.org), the selected in the control and the intervention group. Informed written consent will be obtained from the children's parents as well as verbal consent from the child to participate in the research. Demographic data will be recorded from the child's medical record. Foot reflexology massage will be performed by a researcher who was trained in this field and according to the standard instructions, during 2 consecutive days. In all cases , first the child will be connected to cardiorespiratory monitoring and then the form of physiological indicators (blood pressure, heart rate, arterial blood oxygen saturation) Cornell delirium questionnaire for children, 5 minutes before the floor reflex massage. In intervention group, in addition to providing the usual care of the ward. Then, immediately after intervention, the Physiological Index Form of the Children's Cornell Delirium will be completed 2 hours later. In control group, the physiological indicators form will be completed 33 minutes later and the children's delirium kernel questionnaire will be completed 2 hours and 33 minutes after the initial assessment.
Participants/Inclusion and exclusion criteria
74 children hospitalized in the pediatric intensive care unit
Intervention groups
foot reflexology massage- control group
Main outcome variables
Delirium; physiologic parameters
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230202057303N3
Registration date:2024-04-19, 1403/01/31
Registration timing:prospective
Last update:2024-04-19, 1403/01/31
Update count:0
Registration date
2024-04-19, 1403/01/31
Registrant information
Name
Mona Alinejad naenie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1180
Email address
mona_alinejad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-29, 1403/02/10
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Foot Reflexology Massage on Delirium and Physiological Indicators in Children Admitted to Pediatric Intensive Care Unit: A randomized clinical trial
Public title
The effect of Foot Reflexology Massage on Delirium and Physiological Indicators in Children Admitted to Pediatric Intensive Care Unit: A randomized clinical trial
Purpose
Supportive
Inclusion/Exclusion 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:
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)
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Using computerized randomization (www.randomizer.org), continuously selected children will be placed in the control group and the intervention group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Working Group/Committee of Ethics in Research of Iran University of Medical Sciences
Street address
Nursing and Midwifery Faculty, Rashid Yasmi St., Valiasr St.
City
Tehran
Province
Tehran
Postal code
1436944694
Approval date
2023-11-15, 1402/08/24
Ethics committee reference number
IR.IUMS.REC.1402.725
Health conditions studied
1
Description of health condition studied
Delirium
ICD-10 code
F05
ICD-10 code description
Delirium, not induced by alcohol and other psychoactive substances
Primary outcomes
1
Description
Delirium
Timepoint
5 minutes before the intervention - immediately after the intervention
Method of measurement
Cornell Assessment of Pediatric Delirium (CAPD)
Secondary outcomes
1
Description
Physiological Indicators
Timepoint
5 minutes before the intervention - immediately after the intervention
Method of measurement
Monitoring connected to the child
Intervention groups
1
Description
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 shampoo to wash their feet. The researcher will massage the hands together with a small amount of baby oil to make the soles of the feet slippery, while creating a suitable and even heat for the hand. The heating stage is actually a basic and general type of massage that is aimed at familiarizing the foot with the hands of the masseur. In the relaxation phase, the reflex points of the brain, pituitary, hypothalamus, heart, lungs, and solar plexus will be massaged on both feet for 10 minutes. This massage will be done on 2 consecutive days.
Category
Treatment - Other
2
Description
Control group: No intervention is received
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Asghar Children's Hospital
Full name of responsible person
Zahra Mazhary
Street address
Hazrat Ali Asghar Children's Hospital, Shahid Dastgardi Street (Zafar), after Mirdamad Bridge, Modares Highway
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2222 2041 ext. 5
Fax
+98 21 2222 0063
Email
zamazhari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of research and technology of Iran University of Medical Sciences
Full name of responsible person
Reza Falak
Street address
Iran University of Medical Sciences, 5th floor of the central headquarters, Hemat Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
falak.r@iums.ac.ir
Grant name
Deputy of research and technology of Iran University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research and technology of Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mona Alinejad-Naeini
Position
faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty of Iran University of Medical Sciences, Rashid Yasmi St., Valiasr St.
City
Tehran
Province
Tehran
Postal code
1436944694
Phone
+98 21 4365 1605
Email
alinejad.m@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mona Alinejad-Naeini
Position
faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty of Iran University of Medical Sciences, Rashid Yasmi St., Valiasr St.
City
Tehran
Province
Tehran
Postal code
1436944694
Phone
+98 21 4365 1605
Email
alinejad.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mona Alinejad-Naeini
Position
faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty of Iran University of Medical Sciences, Rashid Yasmi St., Valiasr St.
City
Tehran
Province
Tehran
Postal code
1436944694
Phone
+98 21 4365 1605
Email
alinejad.m@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available