Protocol summary

Study aim
Comparing the effect of tub and swaddled bathing method on premature neonate's stress behavior responses in NICU
Design
In this study, 80 premature infants who have inclusion criteria were randomly divided into two equal groups of 40 subjects with the same conditions. In group 1, the babies were bathed by swaddled bathing method and in group 2 , babies bathed by tube bathing method.
Settings and conduct
in this double - blind study, First, referring to the Ayatullah Rouhani Hospital, a referral letter from Babol University of Medical Sciences, and after coordination with the boss of the hospital and the NICU's head nurse. After explaining the purpose of the research and explaining the method of work to the parents, informed consent will be obtained from the parent of each baby. 80 premature infants who have inclusion criteria were randomly divided into two equal groups of 40 subjects with the same conditions. In group 1, the babies were bathed by swaddled bathing method and in group 2 , babies bathed by tube bathing method.In this study, a group of neonates are bathed by swaddled bathing method and the other group are bathed by tube bathing method with a standard detergent solution in a NICU with an ambient temperature of between 26-27 ° C and water at a temperature between 37-37.5 ° C, They are bathed by the researcher. In the swaddled bathing group, the neonates are wrapped in a soft towel with their arms and legs kept in a flexed midline position they are fully immersed from the shoulders down in a plastic tub 9 cm depth of warm water . The eyes were first washed with a soft cotton cloth and warm water from the inner corner of the eye. the baby's limb are washed slowly with a mild detergent and soft cotton cloth and then washed off the leg and genital area. The other part of the baby's body is washed so that the hair and the baby's head are washed off at the end The baby is put in a dry towel. After warming, under radiant transferred to the incubator. tub bathing group in this method, the baby is completely immersed in warm water in a plastic tub with a depth of 9 cm. Then the baby's body is washed with a cloth and a mild detergent. Then the head and hair are washed and wrapped in a towel and after warming under radiant transfer to the incubator. The duration of bathing filmed by researcher and these film revewed by some one other than researcher.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Gestational age less than 37 week, no major congenital abnormality, not using sedatives or skeletal muscle relaxant, age between 3-54 day and exclusion criteria; Major congenital abnormality,sepsis, surgery, seizure, treatment with sedatives and muscle relaxant,mechanical ventilation, risk of aspiration, agitation, metabolic disorders and Intraventricular hemorrhage
Intervention groups
In this study, a group of neonates are bathed by swaddled bathing method and the other group are bathed by tube bathing method with a standard detergent solution in a NICU with an ambient temperature of between 26-27 ° C and water at a temperature between 37-37.5 ° C, They are bathed by the researcher. In the swaddled bathing group, the neonates are wrapped in a soft towel with their arms and legs kept in a flexed midline position they are fully immersed from the shoulders down in a plastic tub 9 cm depth of warm water . The eyes were first washed with a soft cotton cloth and warm water from the inner corner of the eye. the baby's limb are washed slowly with a mild detergent and soft cotton cloth and then washed off the leg and genital area. The other part of the baby's body is washed so that the hair and the baby's head are washed off at the end The baby is put in a dry towel. After warming, under radiant transferred to the incubator. tub bathing group in this method, the baby is completely immersed in warm water in a plastic tub with a depth of 9 cm. Then the baby's body is washed with a cloth and a mild detergent. Then the head and hair are washed and wrapped in a towel and after warming under radiant transfer to the incubator
Main outcome variables
newborn's Stress behavior during bathing

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171128037658N1
Registration date: 2018-01-24, 1396/11/04
Registration timing: retrospective

Last update: 2018-01-24, 1396/11/04
Update count: 0
Registration date
2018-01-24, 1396/11/04
Registrant information
Name
Sakineh Mokhtari naseri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 5224 4076
Email address
s.mokhtar@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-31, 1396/03/10
Expected recruitment end date
2018-01-10, 1396/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of tub and swaddled bathing method on premature neonate's stress behavior responses in nicu
Public title
effect of tub and swaddled bathing on premature neonate's stress
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age less than 37w, no major conjenital abnormality, not using sedatives or skeletal muscle relaxan, age between3-54day
Exclusion criteria:
Major conenital abnormality,sepsis,sergery,seizure, treatment with sedatives and muscle relaxant,mekanical ventilation, risk of aspiration, agitation, metabolic deases and IVH
Age
From 3 days old to 54 days old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 80
More than 1 sample in each individual
Number of samples in each individual: 40
In this study preterm neonates divided in two groups of 40 neonates that that bathing by tub and swaddled method.
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study preterm neonates divided in two groups of 40 neonates that that bathing by tub and swaddled method. The duration of bathing filmed by researcher and these film check by some one other than researcher. In this research the evaluator is blinded.
Placebo
Not used
Assignment
Parallel
Other design features
In this study, the film is reviewed by someone other than the researcher. stress behavior response during bathing are calculated every 10 second

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of babol medical medical sciences
Street address
Babol medical univercity Ganj afrooz avenue
City
babol
Province
Mazandaran
Postal code
4661946581
Approval date
2017-12-07, 1396/09/16
Ethics committee reference number
MUBABOL.HRI.REC.1396.120

Health conditions studied

1

Description of health condition studied
newborn's stress behavior
ICD-10 code
Z74
ICD-10 code description
Problems related to care provider dependency

Primary outcomes

1

Description
Stress behavior
Timepoint
The stress behavior is calculated only during the bathing , which last less than 10 minutes.
Method of measurement
by the film that taken by the researcher during bathing, it evaluate by someone other than the researcher and the number of these behaviors is calculated every 10 seconds according to the checklist.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Group 1 infants are bathed by swaddled bathing method.
Category
N/A

2

Description
Intervention group: Group 2 is bathed by by immersion tubbathing method
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
ayatollah rohani hospital
Full name of responsible person
sakineh mokhtari naseri
Street address
Babol ganj afrooz avenue next to ghadir pool roohani hospital
City
babol
Province
Mazandaran
Postal code
4661946581
Phone
+98 11 5224 4076
Email
s.mokhtari@mubabol.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
sakineh mokhtari naseri
Street address
babol medical univercity ganj afrooz avenue
City
babol
Province
Mazandaran
Postal code
4661946581
Phone
+98 11 5224 4076
Email
s.mokhtar@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Abadan University of Medical Sciences
Proportion provided by this source
1
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
Babol University of Medical Sciences
Full name of responsible person
sakineh mikhtari naseri
Position
master science student in neonatal intensive care feild
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
babol medical science univercity ganj afrooz avenue
City
babol
Province
Mazandaran
Postal code
4661946581
Phone
+98 52244076
Email
s.mokhtar@mubabol.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
sakineh mokhtari naseri
Position
master science in neonatal intensive care feild
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
babol medical science univercity ganj afrooz avenue
City
babol
Province
Mazandaran
Postal code
4661946581
Phone
+98 11 5224 4076
Email
s.mokhtari@mubabol.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Sakineh mokhtari naseri
Position
Master.science student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Babol medical univercity Ganj afrooz avenue
City
Babol
Province
Mazandaran
Postal code
4661946581
Phone
+98 11 5224 4076
Fax
+98 11 5224 3006
Email
S.mokhtar@mubabol.ac.ir
Web page address

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
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
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
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