Determining the effect of mother's supportive interventions on preterm infant stress during swaddle bath
Design
Randomized controlled clinical trial with control group، Randomized with Randlist software , single blind With 50 samples
Settings and conduct
Nicu of Ahar Hospital,Entry of samples according to the inclusion criteria Obtaining written consent,Baby bathing was performed in the presence of the mother, and supportive measures were taken before and during the bathing by the mother, and newborn stress was measured by the Newborn stress scale.
Participants/Inclusion and exclusion criteria
Inclusion criteria:1) infants with gestational age of 30-37 weeks 2) birth weight 1500 g or more 3) neonate age 3 days or more. 4)Doctor's order for Bathing the baby 5)body temperature ranging from 36.5 to 37.5 °C 6)stable vital signs and no oxygen required 7) parental consent 8) Non-feeding baby at least one hour before bath.
Exclusion criteria: 1) Symptoms such as apnea and cyanosis or any illness during bathing 2) Seizure or physiological instability 3) Use of sedatives and muscle relaxants 4) Chromosomal abnormality or congenital malformations 5)IVH
Intervention groups
In the intervention group, the infant will be supported 8 minutes before the bath and during the bath by the mother by the gentle touch of the face, kissing and talking. In the control group, the baby will be bathed by the researcher in the presence of the mother, and supportive measures will be taken by the mother.
Main outcome variables
stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100823004617N15
Registration date:2019-11-12, 1398/08/21
Registration timing:retrospective
Last update:2019-11-12, 1398/08/21
Update count:0
Registration date
2019-11-12, 1398/08/21
Registrant information
Name
Mahnaz Jabraeili
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
jabraeilim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-31, 1397/05/09
Expected recruitment end date
2019-01-29, 1397/11/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mother's supportive interventions on preterm infant stress during swaddle bath: randomized controlled clinical trial
Public title
The effect of mother's supportive interventions on preterm infant stress during swaddle bath: randomized controlled clinical trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
infants with gestational age of 30-37 weeks.
birth weight 1500 g or more
neonate age 3 days or more
Doctor's order for Bathing the baby
body temperature ranging from 36.5 to 37.5 °C
stable vital signs and no oxygen required.
parental consent
Non-feeding baby at least one hour before bath
Exclusion criteria:
Symptoms such as apnea and cyanosis or any illness during bathing
Seizure or physiological instabilit
Use of sedatives and muscle relaxants
Chromosomal abnormality or congenital malformations
IVH
Age
From 3 days old to 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be selected by available method and randomly divided into intervention and control groups using Rand List software. To completely hide the allocation, the block sizes will not be the same and the letters A and B will be placed in the envelope respectively and the first baby will be given envelope number 1 and envelope number respectively. After opening the envelope, the type of group will be specified.
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
Tabriz University of Medical Sciences Ethics Committee
Street address
Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947979
Approval date
2019-07-14, 1398/04/23
Ethics committee reference number
IR.TBZMED.REC.1398.429
Health conditions studied
1
Description of health condition studied
Bath outcome in preterm infants
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Stress
Timepoint
8 minutes before starting until 5 minutes after bath
Method of measurement
Newborn stress scale (NSS) tool
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, the infant will be supported 8 minutes before the bath and during the bath by the mother by the gentle touch of the face, kissing and talking.
Category
Other
2
Description
In the control group, the baby will be bathed by the researcher in the presence of the mother, and supportive measures will be taken by the mother during the bath.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Bagherololum Ahar Hospital Affiliated Medical Sciences of Tabriz,Iran
Full name of responsible person
Nasim soltani
Street address
Bagherololum Ahar Hospital
City
Ahar
Province
East Azarbaijan
Postal code
5451881151
Phone
+98 41 4433 2004
Email
info@aharhosp.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Rashidi
Street address
Researchِ Department - Central Building- Golgasht-Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
---
Phone
+98 41 3335 5921
Email
info@medfac.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Nasim soltani
Position
Nursing Master of Science student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shariati South St, Faculty of Nursing and Midwifery,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3479 6969
Email
soltani.n95@gmail.com
Web page address
https://nursing.tbzmed.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahnaz Jabraeli
Position
Phd.Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Pediatrics
Street address
Shariati South St, Faculty of Nursing and Midwifery,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3479 6969
Email
Jabraelim@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Nasim soltani
Position
Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shariati South St, Faculty of Nursing and Midwifery,Tabriz, Iranایران، تبریز، خیابان شریعتی جنوبی، دانشکده |پرستاری و مامایی شهر Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
Soltani.n95@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
---
When the data will become available and for how long
---
To whom data/document is available
---
Under which criteria data/document could be used
---
From where data/document is obtainable
---
What processes are involved for a request to access data/document