Determining the effect of maternal massage by mother on depression and maternal fatigue in referring to selected clinics of Iranshahr University of Medical Sciences in 1397-1396
Design
72 mothers with inclusion criteria are randomly assigned to intervention or control groups. The intervention group will receive infant massage training, while the control group will receive routine care only.
Settings and conduct
A total of 72 mothers with healthy infant who had mild to moderate depression, were randomly assigned to control and intervention group. The multidimensional fatigue questionnaire and Edinburgh Depression questionnaire were used before and 4 weeks and 8 weeks after the intervention. In this study, the field massage technique will be used as the intervention. The infants in the intervention group will receive the intervention 15 minutes a day, for 8 weeks. The control group will receive routine care.
Participants/Inclusion and exclusion criteria
Entry criteria:
It wants to cooperate
Non-entry criteria: Having addicted and divorced
Intervention groups
Massage will be given to the mothers In the intervention group who come to the first postnatal care. Moms massage their baby for 8 weeks every day for 15 minutes. Field massage technique is used. The control group receives routine care.
Main outcome variables
Depression score; Fatigue score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180618040135N1
Registration date:2018-11-02, 1397/08/11
Registration timing:registered_while_recruiting
Last update:2018-11-02, 1397/08/11
Update count:0
Registration date
2018-11-02, 1397/08/11
Registrant information
Name
khorshid rigi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3722 0483
Email address
shahnavazi.a@irshums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-05, 1397/04/14
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of infant massage on maternal depression and fatigue in mothers referred to selected clinics of Iranshahr University of Medical Sciences
Public title
The effect of infant massage on maternal depression and fatigue in mothers referred to selected clinics of Iranshahr University of Medical Sciences
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
It wants to cooperate
Exclusion criteria:
Having addiction
divorced
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
First, they are sampled in a class, that is, half of the samples will be primiparous and the other half will be multiple.Block randomization method was used. To implement this method, two letters A and B represent the intervention and control group.
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
Ethics committee of Shiraz University of Medical Sciences
Street address
opposite Palestine Street,Zand Ave, Central Building of Shiraz University of Medical Sciences, shiraz
City
shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Approval date
2018-05-09, 1397/02/19
Ethics committee reference number
IR.SUMS.REC.1397.147
Health conditions studied
1
Description of health condition studied
Postpartum Depression
ICD-10 code
F53.0
ICD-10 code description
Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified
Primary outcomes
1
Description
Edinburgh Depression Score
Timepoint
Before starting the intervention 4 and 8 weeks after the intervention
Method of measurement
Edinburgh Depression Inventory
2
Description
Fatigue score
Timepoint
Before starting the intervention 4 and 8 weeks after the intervention
Method of measurement
Fatigue Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Baby massage Daily for 15 minutes for 8 weeks with Mom by Field Massage Technique
Category
Prevention
2
Description
Control group: Routine care is done
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers of Iranshahr University of Medical Sciences
Full name of responsible person
Khorshid Rigi
Street address
No. 46، Imam Khomeini Street, Iranshahr School of Medical Sciences and Health Services
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
۹۹۱۶۶۴۳۵۳۵
Phone
+98 54 3721 3891
Fax
+98 54 3721 3308
Email
khorshid.rigi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research of Shiraz University of Medical Sciences
Full name of responsible person
dr.younes ghasemi
Street address
No. 8, Central Building of Shiraz University of Medical Sciences, Opposite to Palestine Street, Zand Ave, shiraz
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3230 5410
Email
roose82003@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research of Shiraz 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
Iranshahr University of Medical Sciences
Full name of responsible person
Khorshid Rigi
Position
Non-faculty trainer
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 46، Imam Khomeini Street, Iranshahr School of Medical Sciences and Health Services
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
۹۹۱۶۶۴۳۵۳۵
Phone
+98 54 3721 3891
Email
khorshid.rigi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranshahr University of Medical Sciences
Full name of responsible person
Khorshid Rigi
Position
Instructor
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No 1 alzahra street
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
۹۹۱۶۶۴۳۵۳۵
Phone
+98 54 3722 0483
Fax
Email
shahnavazi.a@irshums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iranshahr University of Medical Sciences
Full name of responsible person
Khorshid Rigi
Position
Instructor
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No 1 alzahra street
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
۹۹۱۶۶۴۳۵۳۵
Phone
+98 54 3722 0483
Fax
Email
shahnavazi.a@irshums.ac.ir
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