The effect of family-centered empowerment program on sleep quality and mental health of primiparous women in postpartum period
Design
The non-blinded Randomized Clinical Trial (RCT) with controls, parallel groups and sample size of 90 participants will be conducted. Allocation of samples in control and intervention groups will be done randomly and using a card in at the packets with dark inner covers being selected by participating women. Then, the research samples will select each packet voluntarily.
Settings and conduct
The place of the study will be two out of three health centers located in the Astara city, Gilan province,Iran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Primiparous women; mother's willingness to participate in the study; singleton pregnancy; direct infant responsibility with mother.
Non-inclusion criteria: Educated in one of the disciplines of medical science; Any acute or chronic maternal illness; Cigarette and alcohol use; Medical prohibition to breastfeed (based on the case's document); Congenital infant disease requiring hospitalization; Maternal or infant hospitalization due to underlying illness
Intervention groups
In intervention group 4 sessions are held in which the caregiver, husband and infant are present. The family-based empowering model will be implemented step by step in 4 sessions (2 hours per session and once in a week). At the same time the control group only receive routine care. The final evaluation in both groups will be done one month after the treatment.
Main outcome variables
Sleep quality, Mental health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110425006284N16
Registration date:2019-10-22, 1398/07/30
Registration timing:registered_while_recruiting
Last update:2019-10-22, 1398/07/30
Update count:0
Registration date
2019-10-22, 1398/07/30
Registrant information
Name
Maryam Modarres
Name of organization / entity
Tehran university of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6656 8142
Email address
modarres@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-03-18, 1398/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of family-centered and individual-centered empowerment program on sleep quality and mental health of primiparous women in postpartum period
Public title
Comparison of family-centered and individual-centered empowerment program on sleep quality and mental health
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous women
Mother's willingness to attend study
Single pregnancy
Direct infant responsibility with mother
Exclusion criteria:
educated in one of the fields of medical science
Any acute or chronic maternal illness
Smoking and alcohol
Medical prohibition for breastfeeding mother (based on case's document)
Congenital infant disease requiring hospitalization
Maternal or infant hospitalization due to underlying illness
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of samples in control and intervention groups will be carried out randomly and using cards in packets with dark inner cover being selected by participating women. Then the research samples will select each packet voluntarily. Those participants who select the intervention packets will be the intervention group and others who selected the control cards will be the controls. This process will be continued until the end of sampling.
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 Tehran University of Medical Sciences
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Mirkhani St., Tohid Square, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2019-08-21, 1398/05/30
Ethics committee reference number
IR.TUMS.FNM.REC.1398.099
Health conditions studied
1
Description of health condition studied
Quality of sleep
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Mental health
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sleep quality score in the Petersburg questionnaire
Timepoint
At baseline (before intervention), immediately after intervention (duration of intervention is 4 weeks), 1 month after intervention
Method of measurement
Petersburg sleep quality questionnaire
2
Description
Mental health score in Goldberg General Health Questionnaire
Timepoint
At baseline (before intervention), immediately after intervention (duration of intervention is 4 weeks), 1 month after intervention
Method of measurement
Goldberg General Health Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: is comprised of 45 participants being treated with Dr. Alhani's 4-steps Family-based empowering model (perceived threat from the outcomes, self-efficacy through problem solving, self-esteem through educational participation, and evaluation) in 4 sessions for two hours once in a week and accompanied by their husbands and infants.
Category
Behavior
2
Description
Control group: Includes 45 people who receive routine care
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mohammadzadeh Health Center
Full name of responsible person
Farahnaz Azizi
Street address
Shahid Mohammadzadeh Health Center, Eastern Hakim Nezami Street, Astara
City
Astara
Province
Guilan
Postal code
4391837773
Phone
+98 13 4381 3084
Email
astara@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mommadali Sahraiyan
Street address
Vice Chancellor for Research and Technology, Sixth Floor, central building, Qods Ave., Keshavarz Boulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
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
Maryam Modarres
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Mirkhani St., Tohid Square, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
modarres@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Modarres
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Mirkhani St., Tohid Square, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
modarres@sina.tuns.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farahnaz Azizi
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Islamic Azad University, Astara Branch, Hosein Negadi blvd, Astara Town
City
Astara
Province
Guilan
Postal code
4391983159
Phone
+98 13 4480 2300
Email
f.azizi@iau-astara.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
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after people are unrecognizable
When the data will become available and for how long