Investigation and Comparing the effects of foot reflexology and sucrose 24% with pacifier on severity of neonatal Abstinence syndrome, Hearth rate and Respiratory rate among the neonates with addicted mother
Determining and comparing the effect of reflexology and sucrose with pacifier on severity of substance withdrawal syndrome symptoms in addicted infants
Design
Double-blind clinical trial, block randomization in terms of substance consumption, Fingan score and type of food, with control group, on 90 addicted infants, two intervention groups and one control group in parallel
Settings and conduct
This study will be performed in Pasteur Hospital of Bam city and includes two intervention groups and a control group. Participants are blind (blindness is based on the fact that they are infants) and will be intervened in a separate room. It will also be blind .Reflexology intervention will be performed for minutes. The basis of finger work is walking. In the sucrose group with the pacifier, pour 2 cc of sucrose solution on the front of the baby's tongue, followed by placing the pacifier in the baby's mouth for 15 minutes. The control group will have only the presence of the intervener. Interventions will be performed twice a day for 12 hours. Heart rate, respiration rate and deprivation syndrome score are measured before the intervention and then 15 minutes and 2 hours after the intervention.
Participants/Inclusion and exclusion criteria
Term addicted babies
Get a score of 8 or higher on the Finigan checklist
hospitalized
Lack of congenital problems and problems affecting the symptoms of deprivation
Parental consent
Intervention groups
Reflexology : Babies will receive a foot massage for 15 minutes
Sucrose : Pour 2 cc of sucrose solution on the baby's tongue with a sterile syringe, followed by placing the pacifier in the baby's mouth for 15 minutes.
Control : will have only the presence of the interferer
Main outcome variables
neonatal Abstinence syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131228015965N20
Registration date:2020-09-01, 1399/06/11
Registration timing:registered_while_recruiting
Last update:2020-09-01, 1399/06/11
Update count:0
Registration date
2020-09-01, 1399/06/11
Registrant information
Name
Majid Kazemi
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 7663
Email address
dr.kazemi.n@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-22, 1398/07/30
Expected recruitment end date
2020-10-21, 1399/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation and Comparing the effects of foot reflexology and sucrose 24% with pacifier on severity of neonatal Abstinence syndrome, Hearth rate and Respiratory rate among the neonates with addicted mother
Public title
Investigation and Comparing the effects of foot reflexology and sucrose 24% with pacifier on severity of neonatal Abstinence syndrome among the neonates with addicted mother
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Newborns born with term maternal addiction during pregnancy
Get a score of 8 or higher on the Finigan checklist
Being hospitalized in educational and medical centers of the place of study
Having parental consent
Exclusion criteria:
Having congenital problems, congenital anomalies and injuries during childbirth
Having respiratory problems and other problems affecting the symptoms of deprivation
Age
From 1 day old to 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done by block randomization method and based on that, the participants will be placed in one of the intervention and control groups and in a randomized block in terms of material consumed by the mother and Fingan score and type of feeding. Randomization will be performed by a blind staff to study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants are blind (blindness is based on the fact that they are infants) and will be intervened in a separate room. It will also be blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Rafsanjan University Of Medical Sciences
Street address
Imam Ali Street
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2019-07-16, 1398/04/25
Ethics committee reference number
IR.RUMS.REC.1398.072
Health conditions studied
1
Description of health condition studied
neonatal Abstinence syndrome
ICD-10 code
P96.1
ICD-10 code description
Neonatal withdrawal symptoms from maternal use of drugs of addiction
Primary outcomes
1
Description
on severity of neonatal Abstinence syndrome
Timepoint
Twice a day for 12 hours, before and then 15 minutes and 2 hours after the intervention
Method of measurement
Fingan Tools
Secondary outcomes
1
Description
Number of breaths
Timepoint
Twice a day 12 hours before the intervention, 15 minutes and 2 hours after the intervention
Method of measurement
Counting
2
Description
Heart rate
Timepoint
Twice a day 12 hours before the intervention, 15 minutes and 2 hours after the intervention
Method of measurement
Pulse oximetry device
Intervention groups
1
Description
Intervention group 1: In the sucrose group with pacifier, 2 cc of sucrose solution for infants over 2 kg and 1.5 cc for infants 1.5 to 2 kg and 0.5 cc for infants under 1.5 kg of sucrose 24%(Made by Shahid Ghazi Pharmaceutical Company) Pour a sterile syringe on the front of the baby's tongue, the dose of sucrose was selected based on studies in this field (50) and then put the pacifier in the baby's mouth for 15 minutes. Interventions will be performed twice a day, 12 hours apart. Heart rate was measured using a pulse oximetry device (calibrated and identical), respiration rate was counted, and deprivation syndrome score was measured using the Finigan checklist before the intervention and then 15 minutes and 2 hours after the intervention.
Category
N/A
2
Description
Second intervention group:. In the reflexology group, infants will receive a foot massage (reflexology belief is based on the fact that the foot is a reflection of different organs of the body and foot massage affects different systems). In this intervention, we use zone number one, which is the thumb and toes. We chose that it is directly related to the head and neck and the secretion of endorphins. Reflexology intervention will be performed for 15 minutes. The pressure of the massage is such that the blood supply to the target organ is not disturbed. The basis of Finger Walking is that we first massage the sole of the baby's foot completely, from the heel vertically and walking, with the index finger, and then the desired area will be massaged more. Interventions will be performed twice a day, 12 hours apart. Heart rate using pulse oximetry device (calibrated and identical), number
Category
N/A
3
Description
Control group: The control group will have only the presence of the intervener and the heart rate using the pulse oximetry device (calibrated and identical), the number of breaths counted and the deprivation syndrome score using the Finigan checklist before the intervention and then 15 minutes. And is measured 2 hours after the intervention. Interventions will be performed twice a day, 12 hours apart.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Pastor hospital
Full name of responsible person
Dr.Majid Kazemi
Street address
Khalij Fars Blvd
City
Bam
Province
Kerman
Postal code
7661961676
Phone
+98 34 4431 9400
Email
gholamisedigh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Hamid Hakimi
Street address
Ali ibn Abi Taleb Squre,Imam Ali Street
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0000
Email
dr.kazemi.n@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Sedighe Gholami Shiri
Position
Master Student Of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tavanir Street
City
Kerman
Province
Kerman
Postal code
7618469184
Phone
+98 930 822 5514
Email
gholamidesigh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Majid Kazemi
Position
PHD. in Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Ali ibn Abi Taleb Squre, Imam Ali Street
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
000034283498+
Email
Maj_Kaz@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Sedighe Gholami Shiri
Position
Master Student Of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tavanir Street
City
Kerman
Province
Kerman
Postal code
7618469184
Phone
009899308225514
Email
gholamisedigh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available