Comparative study of the effect of acupuncture and foot reflexology on signs of drug deprivation syndrome among neonatal with addicted mother in the Affiliated medical centers to Rafsanjani University of Medical Sciences, 2017
The present study was a randomized, double blind clinical trial with the aim of Comparative study of the effect of acupuncture and foot reflexology on signs of drug deprivation syndrome among neonatal with addicted mother in the affiliated medical centers to Rafsanjan University of Medical Sciences, 2017. The information gathering tool includes a special evaluation tool for infants with symptoms of substance deprivation syndrome called Finnegan.
The Inclusion criteria to the study includes Infants born of Addicted mothers who receive at least a score of 8 from the Finnegan tool and need to be admitted to hospital and receive drug treatment. the criteria for the exclusion Neonates born of non-addicted mothers will be considered. In this study, the sample size will be 30 neonates. the Infant will be given twice in the study. So that the first day of admission of the Newborn was randomly assigned to one of the acupuncture by attaching a secure ear at the back of the ear or reflexology in zone 1 Twice a day, 12 hours and one hour before the drug is taken. Two interventions of 12 hours of washout will be considered and the signs of deprivation in the infant before and after intervention will be investigated. Finally, the score of symptoms of withdrawal syndrome will be compared before and after each intervention. In this study, the interventionist. Research researcher and The contributor to the research project as Evaluator will be considered in the research project
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016112615965N9
Registration date:2017-08-28, 1396/06/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-28, 1396/06/06
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
Research Deputy of Rafsanjan University of Medical Sciences
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of acupuncture and foot reflexology on signs of drug deprivation syndrome among neonatal with addicted mother in the Affiliated medical centers to Rafsanjani University of Medical Sciences, 2017
Public title
Comparative study of the effect of acupuncture and foot reflexology on signs of drug deprivation syndrome among neonatal
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Neonate with gestational age of at least 37 weeks; Neonate with addicted mother; Neonate with symptoms of drug withdrawal syndrome.
Exclusion criteria: Congenital anomalies; Life-threatening conditions; Maternal damage; Parental dissatisfaction with participation in Study
Age
From 1 day old to 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Rafsanjan University of Medical Sciences
Street address
Rafsanjan
City
Rafsanjan
Postal code
7717933777
Approval date
2017-08-02, 1396/05/11
Ethics committee reference number
IR.RUMS.REC.1396.72
Health conditions studied
1
Description of health condition studied
Neonatal abstinence syndrom
ICD-10 code
P96.1
ICD-10 code description
Neonatal withdrawal symptoms from maternal use of drugs of addiction
Primary outcomes
1
Description
Neonatal abstinence syndrom
Timepoint
Twice a day, 12 hours apart
Method of measurement
Finnegan score
Secondary outcomes
empty
Intervention groups
1
Description
The present study is a randomized clinical trial that will be performed on infants born of addicted mothers in affiliated educational and medical centers to Rafsanjan University of Medical Sciences in 2017. Data collection tool includes the special tools for monitoring the infants with drug deprivation syndrome symptoms called finnegan. In this study, each infant will be participated twice in the study. In the first day of admission, the infant was assigned to acupuncture interventions baby twice a day, and every hour before drug treatment by attaching safety earrings called ear-seed on both ears on the mastoid bone at sj17 point for ten minutes will be done.
Category
N/A
2
Description
. Twelve hours after the first intervention (washing time) This will be applied in foot thumb of infants twice daily at intervals of 12 hours, one hour before receiving medical treatmen For ten minutes the signs of deprivation in the infants before and after the intervention using the finnegan tool will be investigated. At the end, the score of the symptoms of the drug deprivation syndrome will be compared before and after each intervention.
Category
N/A
3
Description
control group
There is no control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ibn Abi Talib Hospital And NikNafs Maternity Hospital
Full name of responsible person
Dr.Majid Kazemi
Street address
Ali Ibn Abi Talib Square, Imam Ali Street And Shahada Street
City
Rafsanjan
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 Talib Square, Imam Ali Street and Shahada Street
City
Rafsangan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?