To Determine The Effectiveness of The Problem Solving Counseling Approach on Adaptation With The Motherhood Role in The Mother with Pre-Term Infant
Design
In This Clinical Trial With The Control Group, 80 Eligible Pregnant Women will be selected Using Convenience Sampling Method and They will be Randomly allocated to Two Groups Intervention and Control using Quaternary Block. The Outcomes of Study is The Adaptation With Motherhood Role. The Adaptation With The Motherhood will be checked by Iranian Version of Adaptation With The Motherhood Questionnaire In two steps before Intervention and Four weeks after delivery.
Settings and conduct
For the Intervention Group, Individually problem-solving Counseling will be done After Childbirth for Four Sessions One Time per week at Ayatollah Mousavi Hospital of Zanjan.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The Mothers with The Preterm Child 34-36 Weeks, Lack of Medical and Obstetric Complication, Living in The City of Zanjan, Having Writing and Reading Literacy, Healthy Baby, Lack of Breastfeeding Contraindication, Getting Score Less Than 13 Basis of Edinburgh Test, The Absence of Anomalies in Infant, Living With Spouse. No Known Mental Illness, Exclusion Criteria: No Desire To Continue The Study Participating. In Any Educational Program, Having More Than Two Sessions Absent in Counseling Meetings, Lack of Access to The Phone Call
Intervention groups
The Intervention Group will be done Individually Problem Solving Counseling. Totally Four Sessions will be done One Time per Week and The Control Group will be got Routine Care.
Main outcome variables
Adaptation With The Motherhood Role
General information
Reason for update
Acronym
PSC
IRCT registration information
IRCT registration number:IRCT20150731023423N11
Registration date:2018-06-24, 1397/04/03
Registration timing:retrospective
Last update:2018-06-24, 1397/04/03
Update count:0
Registration date
2018-06-24, 1397/04/03
Registrant information
Name
Azam Maleki
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3345 4264
Email address
malekia@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-31, 1396/03/10
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Problem Solving Counseling Approach on Adaptation with The Motherhood Role in Women with Preterm Infant
Public title
The Effectiveness of Problem Solving Counseling Approach on Adaptation with The Motherhood Role in Women with Preterm Infant
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Preterm Labor 34-36 Weeks
Living in The City of Zanjan
Having Writing and Reading Literacy
Lack of Medical and Obstetric Complication
Lack of Breastfeeding Contraindication
Getting Less Than 13 Score Basis of Edinburgh Test
The Absence of Anomalies in Infant
Living With Spouse
No Known Mental Illness
Exclusion criteria:
No Desire To Continue The Study
Participateing In Any Educational Program
Having More Than Two Sessions Absent in Counseling Meetings
Lack of Access to The Phone Call
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible Women will be Selected Using The Convenience Sampling Method and will be Randomly Allocated to The Intervention and The Control Groups Using Quaternary Block.
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 Zanjan University of Medical Sciences
Street address
Azadi Blvd, Zanjan University of Medical Sciences, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
45154
Approval date
2017-05-16, 1396/02/26
Ethics committee reference number
ZUMS.REC.1396.22
Health conditions studied
1
Description of health condition studied
The Adaptation With The Motherhood Role
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Adaptation With The Motherhood Role
Timepoint
Before Intervention, Four Weeks After Intervention
Method of measurement
Questionnaire of Adaptation With Motherhood Role
Secondary outcomes
empty
Intervention groups
1
Description
Individually Counseling will be based On The Problem-Solving Approach Concerning Adaptation with The Motherhood Role. It Includes Care of The Baby, Breastfeeding, Strengthening The Relationship with The Spouse and Child. Counseling will be done in 45-60 Minutes at 4 Sessions.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital of Zanjan
Full name of responsible person
Atefeh Rajabi, MSc in Midwifery Counseling
Street address
Gavazang Road, Ayatollah Mousavi Hospital of Zanjan, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
45154
Phone
+98 24 3345 4264
Email
malekia41@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Shoghli Alireza
Street address
Azadi Blvd, Zanjan University of Medical Sciences, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
45154
Phone
+98 24 3342 0677
Email
Resaerch@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University Of Medical Sciences
Full name of responsible person
Dr. Alireza Shaghli
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Service Management
Street address
Azadi Blvd, Zanjan University Of Medical Sciences, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
45154
Phone
+98 24 3315 6394
Fax
Email
research@zums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Znjan University Of Medical Sciences
Full name of responsible person
Dr. Maleki Azam
Position
PHD Mother & Child Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Gavazang Road, Zanjan University Of Medical Sciences, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4515789589
Phone
+98 24 3314 8364
Fax
+98 24 3314 8319
Email
Malekia@Zums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Atefeh Rajabi
Position
MSc in Midwifery Counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Gavazang Road, Zanjan University of Medical Sciences, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
02433148319
Phone
+98 33420651024
Fax
Email
Atefeh.Rajabi80@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
It will be done by The Rules of the Ethics Committee.