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The effect of Cognitive-Behavioral counseling on sexual function in near-death mothers at health centers

Protocol summary

Study aim
The effect of cognitive-behavioral counseling on sexual function in near-death women
Design
The Clinical trial that is: with control group, with parallel groups, not blinded, randomized method was used, was based on the findings from previous studies. 48 cases (24 cases in each group) were determined for randomization with the help of med-calc statistical software with 95% power and 5% error.
Settings and conduct
Sampling will be administrated based on inclusion and exclusion criteria of the study by inviting women who are listed as near-death patients in hospitals. the study will be conducted in the west public health center of Ahvaz, after obtaining written informed consents from all participants. cognitive-behavioral therapy (CBT) sessions, as the method of the study, will be delivered weekly to the participants for eight continuous weeks. Due to advisory nature of this study, blinding will not be possible.
Participants/Inclusion and exclusion criteria
Inclusion criteria 1- Severe morbidity during labor 2- History of at least one delivery 3. Passing eight to twelve weeks since delivery 4- Having minimum literacy 5-Women whose sexual function score is less than 26 Exclusion criteria 1- Having a known mental illness 2- Taking psychiatric drugs 3. Reluctance to participate in the study 4- Abortion in the recent pregnancy.
Intervention groups
For the intervention group, cognitive-behavioral counseling is used as the intervention. In this method, counseling is given for 8 weeks, one session per week and90minutes per session. Session 1:Interview, Session 2:Helping to Understand the Problem, Session 3:Cognitive Reconstruction, Session 4:Raising sexual knowledge, Session 5:Asexual Sensitivity Training, Session 6:Sex Sensitivity Training, Session 7:Teaching how to have sex, Session 8:Expression of results and conclusions. Control group: do not receive any intervention.
Main outcome variables
sexual function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200612047744N1
Registration date: 2020-12-09, 1399/09/19
Registration timing: registered_while_recruiting

Last update: 2020-12-09, 1399/09/19
Update count: 0
Registration date
2020-12-09, 1399/09/19
Registrant information
Name
Shohreh Dasht peyma
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3376 5834
Email address
shohreh.dashtpeyma3693@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Cognitive-Behavioral counseling on sexual function in near-death mothers at health centers
Public title
The effect of Cognitive-Behavioral counseling on sexual function in near-death women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Near-death mothers with severe pregnancy complications A history of at least one delivery Passing eight to twelve weeks since delivery Having minimum literacy Women whose sexual function score is below 26
Exclusion criteria:
Having a known mental illness Taking psychiatric medication Reluctance to participate in the study Abortion in her recent pregnancy
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Ahwaz Jundishapur University of Medical Sciences
Street address
Central Organization Building , Esfand Ave , Golestan Blvd , Golestan District
City
Ahwaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2020-06-13, 1399/03/24
Ethics committee reference number
IR.AJUMS.REC.1399.255

Health conditions studied

1

Description of health condition studied
Sexual function
ICD-10 code
F52.9
ICD-10 code description
Unspecified sexual dysfunction not due to a substance or known physiological condition

Primary outcomes

1

Description
sexual function quality
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Female Sexual Function Index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For this group, cognitive-behavioral counseling is used. In this method, counseling is given for 8 weeks, one session per week and 90 minutes per session. This is a type of psychotherapy that helps patients understand the thoughts and feelings that affect behaviors. Session 1: Interview, Session 2: Helping to understand the problem, Session 3: Cognitive reconstruction, Session 4: Raising sexual knowledge, Session 5: Teaching asexual sensing, Session 6: Sexual sensing training, Session 7: Teaching how to have sex, Session 8: Expression of results and conclusions. Meetings will be held by a trained researcher in the presence of a consultant professor in some sessions.
Category
Behavior

2

Description
Control group: This group will not receive any intervention.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahwaz West Health Center
Full name of responsible person
Shohreh Dashtpeyma
Street address
Ahwaz West Health Center ,16th East Ave , Kiyanabad
City
Ahwaz
Province
Khouzestan
Postal code
6155644379
Phone
+98 61 3391 4220
Fax
+98 61 3391 4235
Email
shohreh.dashtpeyma3693@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mehdi Ahmadi Moghaddam
Street address
Research building, Ahvaz University Of Science ,Esfand Ave , Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 2414
Fax
+98 61 3336 2414
Email
iitc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Shohreh Dashtpayma
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No.123/1 , West Mordad Ave , Kianpars Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 916 616 3693
Email
shohreh.dashtpeyma3693@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr.Parvin Abedi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, University of Medical Sciences, Esfand Ave , Golestan Blvd , Golestan District
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 916 313 2793
Email
parvinabedi@ymail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Parvin Abedi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, University of Medical Sciences, Esfand Ave , Golestan Blvd , Golestan District
City
Ahvaz
Province
Khouzestan
Postal code
61556443791
Phone
+98 61 3373 8331
Email
parvinabedi@ymail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data set used in this study will be available upon request from the corresponding person.
When the data will become available and for how long
After the publication of the manuscript
To whom data/document is available
For public
Under which criteria data/document could be used
Upon the request from the corresponding author
From where data/document is obtainable
shohreh.dashtpeyma3693@gmail.com
What processes are involved for a request to access data/document
After sending an e-mail to the corresponding author
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