Determining the effect of counseling based on health promotion awareness in newly married women's selfcare needs
Design
A randomized, double-arm clinical trial will be performed on 64 newly married women aged 15 to 40 years old. Participants will be assigned to two groups using RAS software in 4 and 6 blocks with a 1: 1 ratio, and They will be followed up 4 weeks after the intervention.
Settings and conduct
This study will be performed on newly married women aged 15 to 40 years old, whose details are available in health centers in Tehran. Participants will be randomly assigned to two groups. Before the intervention and 4 weeks after the intervention, the questionnaire of sexual self-care and reproductive needs and sexual health literacy will be completed by both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: married women 15 to 40 years old (that have been married at least six months); score for sexual and reproductive self-care needs more than 142.53; literacy for reading and writing.
Exclusion criteria: cancer or a history of cancer; history of participating in previous educational and interventional programs related to sexual and reproductive health; intellectual disability; any psychological illness according to the person.
Intervention groups
For the intervention group, 40- to 60-minute individual counseling sessions will be conducted for 4 consecutive weeks. If needed, one or two more sessions will be held. For the control group, a 60-90 minute consultation session on mental health during pregnancy will be held.
Main outcome variables
Comparison of the score of sexual and reproductive self-care needs will be measured 4 weeks after the intervention by the sexual and reproductive self-care needs questionnaire.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171007036615N7
Registration date:2021-09-21, 1400/06/30
Registration timing:prospective
Last update:2021-09-21, 1400/06/30
Update count:0
Registration date
2021-09-21, 1400/06/30
Registrant information
Name
عصمت مهرابی
Name of organization / entity
دانشگاه علوم پزشکی تبریز
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 0649
Email address
mehrabie@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling based on health promotion awareness in newly married women's selfcare needs: a clinical randomized controlled trial
Public title
The effect of counseling based on health promotion awareness in newly married women's selfcare needs: a clinical randomized controlled trial
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Married women 15 to 40 years old (that have been married at least six months )
Score for sexual and reproductive self-care needs more than 142.53
Literacy for reading and writing
Exclusion criteria:
Cancer or a history of cancer
History of participating in previous educational and interventional programs related to sexual and reproductive health
intellectual disability
Any psychological illness according to the person
Age
From 15 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned to the two groups receiving the intervention and control through simple random blocking using RAS software with 4 and 6 blocks with a ratio of 1: 1. The allocation type will be written on paper and numbered in a series of opaque envelopes (Allocation concealment). The envelopes will be opened in the order in which the participants enter the study.
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 Tabriz University of Medical Sciences
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz,Ira
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2021-04-12, 1400/01/23
Ethics committee reference number
IR.TBZMED.REC.1400.020
Health conditions studied
1
Description of health condition studied
Reproductive and sexual self care needs
ICD-10 code
Z30
ICD-10 code description
Encounter for contraceptive management
2
Description of health condition studied
Sexual and reproductive health literacy
ICD-10 code
Z70
ICD-10 code description
Counseling related to sexual attitude, behavior and orientation
Primary outcomes
1
Description
Sexual and reproductive self-care needs
Timepoint
Before the intervention and 4 weeks after the intervention
Method of measurement
Sexual and Reproductive Self-Care Need assessment Questionnaire
2
Description
Reproductive and sexual health literacy
Timepoint
Before the intervention and 4 weeks after the intervention
Method of measurement
Sexual health literacy for adults Questionnaire (SHELA)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: for the intervention group, 40- to 60-minute individual counseling sessions will be conducted for 4 consecutive weeks. If needed, one or two more sessions will be held.
Category
Behavior
2
Description
Control group: for the control group, a 60-90 minute consultation session on mental health during pregnancy will be held
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Fazel Comprehensive Health Service Center
Full name of responsible person
fereshteh kohansal
Street address
Sazmane Aab St. Hejab St.
City
Tehran
Province
Tehran
Postal code
1359987867
Phone
+98 21 8895 6888
Email
khnsalfrshth@gmail.com
2
Recruitment center
Name of recruitment center
Nematabad Health Center
Full name of responsible person
Fereshteh Kohansal
Street address
Sadeghieh Town, Shahid Poulad Street, Saveh Road
City
Tehran
Province
Tehran
Postal code
1375767962
Phone
+98 21 5582 3055
Email
khnsalfrshth@gmail.com
3
Recruitment center
Name of recruitment center
Dadush Comprehensive Health Service Center - South of Tehran
Full name of responsible person
Narges Mohseni
Street address
Pooneh, Sabalan, Shokoofeh Boulevard
City
Tehran
Province
Tehran
Postal code
1894115999
Phone
+98 21 5588 3656
Email
khnsalfrshth@gmail.com
4
Recruitment center
Name of recruitment center
Abozar health center
Full name of responsible person
Ali Asadi
Street address
Golestan 15th, Southern Nabard
City
Tehran
Province
Tehran
Postal code
1777933112
Phone
+98 21 3302 1605
Email
khnsalfrshth@gmail.com
5
Recruitment center
Name of recruitment center
North Tehran Health Center
Full name of responsible person
Nematollah Mohammadinia
Street address
No. 2/16, Ishraqi Alley, Near to Seyed Khandan Bridge, Shariati St.
City
Tehran
Province
Tehran
Postal code
1798733547
Phone
+98 21 8851 1361
Email
khnsalfrshth@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Samiei
Street address
Central Building, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5613974156
Phone
+98 41 3335 7310
Email
samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Fereshteh Kohansal
Position
Master student of counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, South Shariati, Azadi St.
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
khnsalfrshth@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Esmat Mehrabi
Position
دکتری بهداشت باروری
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, End of South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
b.mehrabi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Esmat Mehrabi
Position
Ph.Din Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, South Shariati, Azadi St.
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
b.mehrabi@yahoo.com
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