Investigating the effect of training based on the self-management empowerment model on the sense of coherence, self-efficacy and anxiety after delivery in cesarean mothers
Determining the effect of training based on the self-management empowerment model on the sense of coherence, self-efficacy and postpartum anxiety in cesarean mothers
Design
The available samples will be divided into blocks of 6, 4 or 8 blocks on 98 people and people will be divided into two groups (B, A). So that group A will only receive training, people in group B will not receive any training
Settings and conduct
After approving and obtaining and providing the permits, the qualified person is referred to the vice president of treatment of the hospital, an informed consent is obtained, and the sample is divided into test and control groups based on random size blocks. Then, all the people will complete the demographic, sense of cohesion, familiarity and anxiety questionnaire and it will be done on the intervention test group. And after the end of 2 months, the questionnaire will be sent online and analyzed after the completion of the experiment.
Participants/Inclusion and exclusion criteria
Having a history of one previous caesarean section .access to a smartphone. Having minimum literacy
. Age 18 to 45 .Not having a history of illness or taking neuropsychiatric drugs based on self-report . Consent to participate in the study;
Having a high-risk pregnancy .Having a stressful event in the last 6 months. Having an abnormal baby or abnormality according to self-report or expert doctor. mothers withdrawing from the study
.Failure to implement more than 40% of the cases specified in the intervention implementation form. Having an emergency caesarean section
Intervention groups
Women candidates for cesarean delivery
Main outcome variables
Efficacy; Anxiety; sense of coherence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130422013092N12
Registration date:2024-07-11, 1403/04/21
Registration timing:registered_while_recruiting
Last update:2024-07-11, 1403/04/21
Update count:0
Registration date
2024-07-11, 1403/04/21
Registrant information
Name
Maryam Ravanipour
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 1455 0187
Email address
ravanipour@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-10, 1403/04/20
Expected recruitment end date
2024-10-11, 1403/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of training based on the self-management empowerment model on the sense of coherence, self-efficacy and anxiety after delivery in cesarean mothers
Public title
Investigating the effect of training based on the self-management empowerment model on the sense of coherence, self-efficacy and anxiety after delivery in cesarean mothers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a history of one previous caesarean section
access to a smartphone
Having minimum literacy
Age 18 to 45
Not having a history of illness or taking neuropsychiatric drugs based on self-report
Consent to participate in the study
Exclusion criteria:
Having a high-risk pregnancy (multiple pregnancy, preeclampsia, etc.
Having a stressful event in the last 6 months
Having an abnormal baby or abnormality according to self-report or expert doctor
mothers withdrawing from the study
Failure to implement more than 40% of the cases specified in the intervention implementation form
Having an emergency caesarean section
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
Available samples will be divided into 6, 4 or 8 blocks and divided into two groups (B, A) by randomly assigning random size blocks. So that group A will only receive self-management empowerment training, in group B people will not receive any training except for routine training in the hospital.
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
Research Ethics Committees of Bushehr province university of medical sciences
Street address
Faculty of Nursing and Midwifery, Bushehr University of Medical Sciences, Salman Farsi Ave, Rishehr Blvd, Bushehr
City
Bushehr
Province
Boushehr
Postal code
7518759338
Approval date
2024-05-26, 1403/03/06
Ethics committee reference number
IR.BPUMS.REC.1403.102
Health conditions studied
1
Description of health condition studied
Sense of coherence, anxiety and self-efficacy in cesarean section women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
attainment to sense of coherence
Timepoint
Before intervention، 2 month after intervention
Method of measurement
Antonovsky sense of coherence questionnaire
2
Description
Attainment to Self Efficacy
Timepoint
En before intervention، 2 month after intervention
Method of measurement
Sharr General Self-Efficacy Questionnaire
3
Description
Achieving the ability to control anxiety
Timepoint
Before intervention، 2 month after intervention
Method of measurement
3. Spielberger anxiety questionnaire
Secondary outcomes
1
Description
Anxiety and self-efficacy after cesarean section
Timepoint
Before intervention
Method of measurement
Based on the achievement of set goals
Intervention groups
1
Description
Intervention group: Based on the achievement of the set objectives of the intervention group: after approving the plan in the ethics council and obtaining the IRCT code and providing the permits, the assistant of treatment of the Persian Gulf Martyrs Hospital and the obstetrics and gynecology department went to the eligible individual first by stating the objectives of the study, consent The informed letter is obtained the night before the people's schedule, the sample is available and its allocation is done to the test and control group based on random size blocks. Then, the people of both groups will individually complete the demographic questionnaire the night before the procedure, after 8 hours of the operation and at least the first breastfeeding and the declaration of readiness by the patient himself, the questionnaire will be completed. and on the intervention test group, based on the self-management empowerment model, the intervention will be carried out during 2 face-to-face sessions according to the participant's desire, and other interventions will be carried out in the form of telephone follow-up 2 times a week until the end of 2 months. Also, after the end of 2 months, the questionnaire will be sent online for both test and control groups, and after the completion of the experiment, the samples will be analyzed.
Category
Lifestyle
2
Description
Control group: Without the intervention
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Persian Gulf Martyrs Hospital in Bushehr
Full name of responsible person
Maryam Ravanipour
Street address
Persian Gulf Martyrs Hospital, Azadi Blvd., Bushehr
City
Bushehr
Province
Boushehr
Postal code
7517933755
Phone
+98 77 3345 5375
Fax
+98 77 3345 5390
Email
ravanipour@bpums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Dr. Seyyed Mohammad Hadi Emamat
Street address
Faculty of Nursing and Midwifery, Bushehr University of Medical Sciences, Salman Farsi Ave, Rishehr Blvd, Bushehr
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 903 892 9788
Email
ravanipour@bpums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Maryam Ravanipour
Position
Professor in Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Bushehr University of Medical Sciences, Salman Farsi Ave, Rishehr Blvd, Bushehr
City
Bushehr
Province
Boushehr
Postal code
7518759338
Phone
+98 77 3345 0187
Email
ravanipour@bpums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Maryam Ravanipour
Position
Professor in Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Bushehr University of Medical Sciences, Salman Farsi Ave, Rishehr Blvd, Bushehr
City
Bushehr
Province
Boushehr
Postal code
7514765199
Phone
+98 77 3345 0187
Email
ravanipour@bpums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Fariba Najafi Shahali Baglo
Position
MSc student of nursing,Student Research Committee, Bushehr University of Medical Sciences
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Bushehr University of Medical Sciences, Salman Farsi Ave, Rishehr Blvd, Bushehr
City
Bushehr
Province
Boushehr
Postal code
7518759338
Phone
+98 77 3345 0187
Email
fnajafi762@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available