Determining the effect of maternal preterm infant massage on mothers' anxiety and self esteem
Design
This study was conducted with 60 samples (intervention group = 30 and control group = 30). The random sampling method is performed by quadruple blocking method.
Settings and conduct
Self-esteem and anxiety questionnaires are filled up at the time of entering the department by the mothers of the control and intervention group.In the intervention group, massage is performed after they are taught to mothers. At the end of 5 days, the anxiety and self-esteem questionnaires are filled by the mothers of the intervention and control group.the mothers were not aware of being in the control or intervention group.
Participants/Inclusion and exclusion criteria
inclusion criteria: Mother does not have any addiction
Mother's does not have any disease like high blood pressure - Gestational diabetes and any maternal physical and mental illness
Preterm Infant with Physiological stability and birth weight between 1500 to 2500 grams
Non-entry criteria: The mother's inability to stay in hospital for any reason
Intervention groups
Rosenberg's self-esteem and Beck's anxiety questionnaires are filled up at the time of entering the department by the mothers of the control and intervention group. Subsequently, in the intervention group, massage is performed after they are taught to mothers. Massage is performed three hours after an infant's lactation under physiological stability of the infant by controlling heart rate, respiration and skin color for 15 minutes in three times for 5 consecutive days. At the end of 5 days, the Beck anxiety and Rosenberg questionnaires self-esteem are filled by the mothers of the intervention and control group and at the end of the analysis, the data will be analyzed and compared in the control and intervention groups.
Main outcome variables
Mothers' anxiety and self esteem score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181004041229N1
Registration date:2018-10-12, 1397/07/20
Registration timing:registered_while_recruiting
Last update:2018-10-12, 1397/07/20
Update count:0
Registration date
2018-10-12, 1397/07/20
Registrant information
Name
Fatemeh Abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3377 9923
Email address
fatemehabbasi3560@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-17, 1397/06/26
Expected recruitment end date
2018-12-17, 1397/09/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of preterm infant massage by mothers on mothers’ anxiety and self-esteem
Public title
Effect of infant massage on mothers’ anxiety and self-esteem
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Mother does not have any addiction
Mother's does not have any disease like high blood pressure - Gestational diabetes and any maternal physical and mental illness
Preterm Infant with Physiological stability and birth weight between 1500 to 2500 grams
Exclusion criteria:
The mother's inability to stay in hospital for any reason
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
A random assignment with quadrilateral blocking will be designed by the Professor of Statistics. The sampler person will be asked the type of group after the assurance of the Sample entry with the Professor of Statistics. In each section, only one type of intervention will be done. Each sample that goes out of the research will be replaced with the next one.
Blinding (investigator's opinion)
Single blinded
Blinding description
The present study is one-blind clinical trial (so that the mothers were not aware of being in the control or intervention group).
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Nursing and Midwifery Faculty and Faculty of Rehabilitation, Tehran University o
Street address
Nosrat street, Tohid square.
City
Tehran
Province
Tehran
Postal code
1419733177
Approval date
2018-08-31, 1397/06/09
Ethics committee reference number
IR.TUMS.FNM.REC.1397.094
Health conditions studied
1
Description of health condition studied
Anxiety and Self-esteem of mothers
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Anxiety
Timepoint
Before the intervention and at the end of the fifth day
Method of measurement
Beck Anxiety questionnaire
Secondary outcomes
1
Description
Self-esteem
Timepoint
Before the intervention and at the end of the fifth day
Method of measurement
Rosenberg self-esteem questionnaire
Intervention groups
1
Description
Intervention group: Self-esteem and anxiety questionnaire is completed first. Massage is done after they are taught to mothers. Massage is performed three times a day after lactation in infants with physiological stability of the baby by controlling heart rate, respiration and skin color for 15 minutes in three times for 5 consecutive days. At the end of 5 days, the anxiety and self-reported questionnaire is again completed.
Category
Rehabilitation
2
Description
Control group: The self-esteem and anxiety questionnaire is completed at first. At the end of 5 days, the anxiety and self-reported questionnaire will be completed again.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Mosavi hospital
Full name of responsible person
Fatemeh abbasi
Street address
Gavazange road, Mosavi hospital
City
Zanjan
Province
Zanjan
Postal code
4515648446
Phone
+98 24 3313 1292
Email
Fatemehabbasi3560@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vida kardan
Street address
Nosrat street, Tohid square.
City
Tehran
Province
Tehran
Postal code
4515648446
Phone
+98 24 3342 1583
Email
fatemehabbasi3560@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh abbasi
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Etemadieh street
City
Zanjan
Province
Zanjan
Postal code
4515648446
Phone
+98 24 3342 1583
Email
fatemehabbasi3560@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Batool pour aboli
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nosrat street, Tohid square.
City
Tehran
Province
Tehran
Postal code
4515648446
Phone
+98 24 3342 1583
Email
b.pouraboli@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh abbasi
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Etemadieh street
City
Zanjan
Province
Zanjan
Postal code
4515648446
Phone
+98 24 3342 1583
Email
Fatemehabbasi3560@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
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