Protocol summary

Summary
This study aims to investigate the effectiveness of a midwife-led group counseling on pregnant women's empowerment and self care in selected Health Centers of Tallish: Based on Orem's self care model and This is a randomized clinical trial without blinding. The sample size will be 74 prime gravid pregnant women. Inclusion criteria: prime gravid Iranian women; having least literacy; Nulliparity; had no significant medical problem such as Hypertension; Diabetes; Bleeding...; they having tendency and conscious consent to inter the study. and exclusion criteria: Unwillingness to continue participation in the study, having physical and psychological diseases by patient word, they being absent counseling sessions not more than 2 sessions. The primary outcome measure is empowerment and self care.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017021627728N4
Registration date: 2017-04-12, 1396/01/23
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-04-12, 1396/01/23
Registrant information
Name
Zohreh Mahmoodi
Name of organization / entity
Nursing&Midwifery faculty
Country
Iran (Islamic Republic of)
Phone
+98 26 3430 4433
Email address
zohrehmahmoodi@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Alborz University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of a midwife-led group counseling on pregnant women's empowerment and self care in selected Health Centers of Tallish 1396: Based on Orem's self care model.
Public title
The effectiveness of a midwife-led group counseling on pregnant women's empowerment and self care in selected Health Centers of Tallish 1396: Based on Orem's self care model.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: prim gravid Iranian women; having least literacy; Nulliparity; had no significant medical problem such as Hypertension; Diabetes; Bleeding; they having tendency and conscious consent to inter the study. and exclusion criteria: Unwillingness to continue participation in the study; having physical and psychological diseases by patient word; they being absent counseling sessions not more than 2 sessions.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Block sampling with random numeral

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Alborz University Of Medical Sciences
Street address
ninth floor, Dara building, north Yasmin, east Pune street, 45 Yards of Golshahr, karaj, IRAN
City
Karaj
Postal code
Approval date
2017-01-28, 1395/11/09
Ethics committee reference number
Abzums.Rec.1395.145

Health conditions studied

1

Description of health condition studied
empowerment
ICD-10 code
z36
ICD-10 code description
Antenatal screening

2

Description of health condition studied
self care
ICD-10 code
Z31.6
ICD-10 code description
General counselling and advice on procreation

Primary outcomes

1

Description
Empowerment
Timepoint
Before intervention _ Immediately after the intervention -3 weeks after intervention
Method of measurement
Use of questionaire

Secondary outcomes

1

Description
Self care
Timepoint
Before intervention _ Immediately after the intervention -3 weeks after intervention
Method of measurement
Use of questionaire

Intervention groups

1

Description
In the intervention group hold 6 consultation sessions weekly based on model of Orem with considering booklet of pregnant women cares for Health Ministry .The time of each session is 90 minute. In the control group hold 2 routine consultation sessions+ educational package weekly and The time of each session is 90 minute
Category
Behavior

2

Description
Control group : They receive routine pregnancy consultation
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Tallish health center (1)
Full name of responsible person
Dr Zohreh Mahmoodi
Street address
Tallish health center (1), Rzeghi alley, Shahid Rajaii Street, Tallish, Guilan, IR
City
Tallish

2

Recruitment center
Name of recruitment center
Tallish health center (2)
Full name of responsible person
Dr Zohreh Mahmoodi
Street address
Tallish health center (2), Danesh amooz Square, Tallish, Guilan, IR.
City
Tallish

3

Recruitment center
Name of recruitment center
Tallish health center (3)
Full name of responsible person
Dr Zohreh Mahmoodi
Street address
Tallish health center (3),Namaz Square, Tallish, Guilan, IR.
City
Tallish

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Dr Mohammad Noori sepehr
Street address
Department of Nursing, Alborz University of Medical Science, Golestan Street, Eshteraki Street, Baghestan, Karaj,IR.
City
Karaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz 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
Alborz University of Medical Sciences
Full name of responsible person
Dr Zohreh Mahmoodi
Position
PhD
Other areas of specialty/work
Street address
Department of Nursing., Alborz University of Medical Science., Eshteraki St., Baghestan Blv Karaj
City
Karaj
Postal code
561-31452
Phone
+98 26 3455 1034
Fax
Email
zohrehmahmoodi2011@gmail.com; zohrehmahmoodi@abzums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Dr Zohreh Mahmoodi
Position
PhD
Other areas of specialty/work
Street address
Department of Nursing., Alborz University of Medical Science., Eshteraki St., Baghestan Blv Karaj
City
Karaj
Postal code
Phone
+98 26 3455 1034
Fax
Email
zohrehmahmoodi2011@gmail.com; zohrehmahmoodi@abzums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Dr Zohreh Mahmoodi
Position
PhD
Other areas of specialty/work
Street address
Department of Nursing., Alborz University of Medical Science., Eshteraki St., Baghestan Blv Karaj
City
Karaj
Postal code
561-31452
Phone
+98 264551034
Fax
Email
zohrehmahmoodi2011@gmail.com; zohrehmahmoodi@abzums.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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