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The effect of implementing the 5A self-management program on the sexual self-esteem of mothers after childbirth

Protocol summary

Study aim
Determining the effect of 5A self-management program on the sexual self-esteem of mothers after childbirth
Design
A controlled, cross-over, double-blind, randomized clinical trial on 90 patients. The sample size was calculated according to the probability of type 1 error 0.5, probability of type 2 error 0.8 and effect size 0.6 by Gpower software for each of the test and control groups of 45 people (90 people in total).
Settings and conduct
Sampling will be conducted using a convenience sampling method for a period of 6 months at Bent Al-Huda Hospital in Bojnourd city. This is a quasi-experimental study involving 90 women who have given birth. Each group will have a sample size of 45 participants. The sexual self-esteem questionnaire will be completed once before the intervention, in both the control and intervention groups. In the control group, participants will receive the routine care of the healthcare center, while the intervention group will receive a 5-step educational program based on the stages of the model and educational content
Participants/Inclusion and exclusion criteria
entery: Married, between the ages of 18 and 45, at least 3 months and at most 6 months have passed since giving birth, the number of births is less than 5 Failure to enter: Getting pregnant while conducting research, the occurrence of anunfortunate and stressful incident in the last 6 months, unwillingness to continue cooperation and not participating in all training sessions
Intervention groups
In the intervention group, a 5-A care program, based on the stages of the model and educational content, will be implemented. Then, the sexual self-esteem questionnaire will be completed.
Main outcome variables
Sexual Self-Esteem Score in Postpartum Women

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230126057235N3
Registration date: 2024-12-31, 1403/10/11
Registration timing: prospective

Last update: 2024-12-31, 1403/10/11
Update count: 0
Registration date
2024-12-31, 1403/10/11
Registrant information
Name
Narges Sefidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3223 6553
Email address
a.abbaszadeh@nkums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-09, 1403/10/20
Expected recruitment end date
2025-07-11, 1404/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of implementing the 5A self-management program on the sexual self-esteem of mothers after childbirth
Public title
The effect of implementing the 5A self-management program on the sexual self-esteem of mothers after childbirth
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Married, between the ages of 18 and 45, at least 3 months and at most 6 months have passed since giving birth, the number of births is less than 5 No history of known mental illnesses and having minimal literacy Not participating in educational programs affecting sexual self-esteem in the last 6 months
Exclusion criteria:
Getting pregnant while conducting research, the occurrence of an unfortunate and stressful incident in the last 6 months, unwillingness to continue cooperation and not participating in all training sessions
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Bojnord University of Medical Sciences
Street address
Bojnord, Shahryar St., above Imam Ali (AS) Hospital, Faculty of Medicine, Vice-Chancellor for Research and Technology of the University
City
Bojnord
Province
North Khorasan
Postal code
94137436941
Approval date
2024-12-23, 1403/10/03
Ethics committee reference number
IR.NKUMS.REC.1403.114

Health conditions studied

1

Description of health condition studied
Routine postpartum follow-up
ICD-10 code
Z39.2
ICD-10 code description
Encounter for routine postpartum follow-up

Primary outcomes

1

Description
The Women's Sexual Self-Esteem Score - Short Form (SSEI-W-SF) consisted of 32 questions
Timepoint
Completing the sexual self-esteem questionnaire at the beginning of the study (before the start of the intervention) and 2, 3, 6, 8 weeks after the start of the care model plan 5A
Method of measurement
The Women’s Sexual Self-Esteem Questionnaire - Short Form (SSEI-W-SF)

Secondary outcomes

empty

Intervention groups

1

Description
Control group: In the control group, they receive the routine care of the treatment center
Category
Lifestyle

2

Description
Intervention group: Care is received in the 5A method.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Bent Al-Hadi Bojnord
Full name of responsible person
Narges sefidi
Street address
Art street
City
Bojnord
Province
North Khorasan
Postal code
94137436941
Phone
+98 58 3223 6551
Email
Sepidin@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
bahram bibak
Street address
Central Building of North Khorasan University of Medical Sciences, Dolat Blvd, Bojnurd
City
Bojnurd
Province
North Khorasan
Postal code
94137436941
Phone
+98 58 3223 6551
Email
Sepidin@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd 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
Bojnourd University of Medical Sciences
Full name of responsible person
Narges Sefidi
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Art street
City
Bojnord
Province
North Khorasan
Postal code
94137436941
Phone
+98 58 3223 6551
Email
Sepidin@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Narges Sefidi
Position
پژوهشگر
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Art street
City
Bojnord
Province
North Khorasan
Postal code
94137436941
Phone
+98 58 3223 6551
Email
Sepidin@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Narges Sefidi
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Central Building of North Khorasan University of Medical Sciences, Dolat Blvd, Bojnurd
City
Bojnurd
Province
North Khorasan
Postal code
94137436941
Phone
+98 58 3223 6551
Email
Sepidin@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The sexual self-esteem score of mothers after childbirth, the relationship between demographic characteristics based on the implementation of the 5A self-management program on the sexual self-esteem of mothers after childbirth
When the data will become available and for how long
6 months
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Publish the article
From where data/document is obtainable
narges sefidi sepidin@yahoo.com
What processes are involved for a request to access data/document
After analyzing the data and printing the article
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