Protocol summary

Summary
The aim of this study is to determine the effect of health-promoting behaviors utilization counseling on mother's quality of life during Post-Partum Period. To perform this advisory from Pender Health Promotion Model was used. This study is a randomized clinical trial study that implement in the two experimental and control groups. Population of this study are mothers attending to health centers during the Post partum Period. Sampling is done through random permutation block. A sample of 58 patients in the intervention group and 58 patients in the control group will determined. Inclusion criteria are: nulliparous mothers, to participate in other training classes during pregnancy and after childbirth, natural childbirth. Exclusion criteria were: absence of more than one meeting in each parent counseling, Postpartum complications, such as infection or bleeding, fetal death during the first six weeks after birth. Intervention consists of three sessions of health-promoting behaviors counseling on days 5-3, 15-10 and 20- 17 after delivery by the investigator to be held. The control group only received routine care after delivery. Comparison will done between two groups on the Quality of life, health-promoting behaviors, self-efficacy, social support and perceived barriers in health-promoting behaviors. Outcome of this study may improve the quality of life of mothers in the Postpartum Period.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016030510426N10
Registration date: 2016-03-27, 1395/01/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-03-27, 1395/01/08
Registrant information
Name
Parisa Parsa
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1822 4396
Email address
parsa@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chanslor of Research in Hamadan University of Medical Sciences
Expected recruitment start date
2015-12-06, 1394/09/15
Expected recruitment end date
2016-04-03, 1395/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of health-promoting behaviors utilization counseling on mother's quality of life during Post-Partum Period
Public title
The effect of health-promoting behaviors counseling on quality of life during Post-Partum period in mothers' attending to health care centers in Hamadan city, 2016
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria included nulliparous mothers, At least be able to read and write and be able to talk and understand the language of Farsi, newborns and has been weighing 2500 to 4000 g, not diagnosed physical and mental illness in mother or fetus ,not problems in pregnancy for both mother and baby, not participate in training class during pregnancy and after childbirth, normal vaginal delivery. Exclusion criteria: immigration, admission to the mother or baby in the hospital for more than 48 hours or hospitalize again after discharge, the absence of a meeting of the mother in each Sessions advice, the mother divorces, lack of breastfeeding baby, Postpartum complications, such as infection or bleeding and Infant mortality during six weeks after birth.
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 116
Randomization (investigator's opinion)
Randomized
Randomization description
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 Hamadan University of Medical Sciences
Street address
Shahid Fahmideh Avenue, Hamadan University of Medical Sciences
City
Hamadan
Postal code
6517838698
Approval date
2015-10-31, 1394/08/09
Ethics committee reference number
IR.UMSHA.REC.1394.343

Health conditions studied

1

Description of health condition studied
Postpartum health Care
ICD-10 code
z39.2
ICD-10 code description
Routine postpartum follow-up

Primary outcomes

1

Description
Health promoting behaviors
Timepoint
3-5 days after birth and 42 days after childbirth
Method of measurement
Health promoting behaviors questionnaire

Secondary outcomes

1

Description
Quality of life
Timepoint
3-5 days after birth and 42 days after childbirth
Method of measurement
Mothers Quality of life questionnaire

2

Description
Self efficacy
Timepoint
3-5 days after birth and 42 days after childbirth
Method of measurement
Self efficacy questionnaire

3

Description
Social support
Timepoint
5-3 days after birth and 42 days after childbirth
Method of measurement
Social support questionnaire

4

Description
Perceived barriers
Timepoint
3-5 days after birth and 42 days after childbirth
Method of measurement
Perceived barriers questionnaire

Intervention groups

1

Description
The experimental group counseling sessions for health-promoting behaviors in small groups of 3-6 people for three one-hour sessions will be held at the health center. The first meeting in 3-5 day after childbirth and second session in 10-15 day after childbirth and the third meeting held in 17-20 day after delivery. After 4 weeks of the last session of counseling, quality of life, health-promoting behaviors, self-efficacy, social support, perceived barriers will be evaluated.
Category
Behavior

2

Description
In the control group received usual care after childbirth and questionnaires completed by them in 3-5 day and 42 day after birth.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Public Health Deputy of Hamadan Univrsity of Medical Sciences
Full name of responsible person
Nazli Alafchi
Street address
Phalastin Square, Public Health Deputy of Hamadan Univrsity of Medical Sciences
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chanslor of Research Hamdan University of Medical Sciences
Full name of responsible person
Dr. Saied Bashirian
Street address
Shahid Fahmideh Street, Hamadan University of Medical Sciences
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chanslor of Research Hamdan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Assistant Professor
Other areas of specialty/work
Street address
Associate Professor
City
Research Center for Chronic Diseases Home Care, Hamadan University of Medicine and Health Sciences,
Postal code
65178
Phone
+98 81 3838 0150
Fax
Email
parsa@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Asistant Professor / PhD
Other areas of specialty/work
Street address
Research Center for Chronic Diseases Home Care, Hamadan University of Medicine and Health Sciences, Shahid Fahmideh Street, Counterpoint of Mardom Park
City
Hamadan
Postal code
65178
Phone
+98 81 3838 0150
Fax
Email
parsa@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Assistant Professor/ Ph.D
Other areas of specialty/work
Street address
Research Center for Chronic Diseases Home Care, Hamadan University of Medicine and Health Sciences, Shahid Fahmideh Street, Counterpont of Mardom Park
City
Hamadan
Postal code
65178
Phone
+98 81 3838 0150
Fax
Email
parsa@umsha.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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