The efficacy of Tele-based sexuality councelling on sextual function and sextual distress of primiparous women with exclusive breastfeeding and their spouses
The efficacy of Tele-based sexuality councelling on sextual function and sextual distress of primiparous women with exclusive breastfeeding and their spouses
Design
The study includes two groups and each group includes 70 people. nonblinded. To determine the sequence of allocation by the block method of four, random allocation sequence generation software "STATA" will be used.
Settings and conduct
The study is conducted among lactating primiparous women referring to Qazvin health centers and their spouses. They are invited to participate in the study based on their willingness, the intervention group will receives 5 counseling sessions. before and after the study, the questionnaires are completed by both control and intervention groups. nonblinded study
Participants/Inclusion and exclusion criteria
Inclusive criteria:
Primiparit,
Married life,
Exclusive breastfeeding,
Have a Singleton term birth,
Being in the first six months after delivery,
Availability within the next two months,
Healthy child without physical problems or special diseases,
Having a smartphone,
Exclusive criteria:
Absence of sexual activity with the spouse during the postpartum period,
Severe marital conflicts and the occurrence of an unfortunate event,
History of chronic mental and physical illness,
Intervention groups
The intervention group will receive a 5-session online training package . Each session is 30-45 minutes.
The control group only receives routine care
Main outcome variables
Primary outcome: couples' sexual performance/couples' sexual distress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220424054637N2
Registration date:2022-10-18, 1401/07/26
Registration timing:prospective
Last update:2022-10-18, 1401/07/26
Update count:0
Registration date
2022-10-18, 1401/07/26
Registrant information
Name
Sara Heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 4241 4105
Email address
mahhaid1371@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2022-12-21, 1401/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of Tele-based sexuality councelling on sextual function and sextual distress of primiparous women with exclusive breastfeeding and their spouses
Public title
The efficacy of Tele-based sexuality councelling on sextual function and sextual distress of primiparous women with exclusive breastfeeding and their spouses
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparity
Living with a spouse
Have exclusive breastfeeding
Have a singleton full-term birth (after 38 weeks)
Being in the first six months after delivery
Being accessible within the next two months
Have a healthy child without physical problems or special diseases
Have smartphone
Exclusion criteria:
Lack of sexual activity with spouse during the postpartum period
Severe marital conflicts and the occurrence of unfortunate events (death of loved ones, accidents, etc.),
Having a history of chronic mental and physical illness (check the records in the file and history)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
We will use block of four for random allocation. In order to determine the sequence of allocation by the four block method, random allocation sequence generation software will be used. In order to hide the sequence of allocation, the papers identifying the group of people are placed inside the envelopes in the opaque package and coded in the same order. In this case, a questionnaire with the same code will be completed for the person who receives the intervention.
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 of Qazvin medical university
Street address
University campus building,Bahonar Blv
City
Qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2022-07-19, 1401/04/28
Ethics committee reference number
IR.QUMS.REC.1401.106
Health conditions studied
1
Description of health condition studied
Sextual function , Sextual distress
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sextual function score
Timepoint
Before and immediately after the end of the study, one week, one month and two months after the intervention
Method of measurement
Female Sexual function Index FSFI-6,International index of erectile function: (IIEF-5)
Secondary outcomes
1
Description
The level of sexual distress of couples
Timepoint
Before and immediately after the end of the study, one week, one month and two months after the intervention.
Method of measurement
Female Sexual Distress Scale (FSDS_R )
Intervention groups
1
Description
Intervention group: Before the intervention, the questionnaire link will be sent through the "Whatsapp "application and the people will be coded. In addition to routine postpartum care, the intervention group will receive five counseling sessions through video calls on "Whatsapp" messenger. Sessions include couples and counselors (three people). "My wife" book (skill training in marital and sexual relations) and the textbook of sexual disorders are considered as educational resources. Counseling sessions are held every 5 days, and after the end of each counseling session, a phone call is made in order to explain more about the training and not to forget the exercises within five days until the next counseling session. Videos, images and educational content related to each session will be provided to couples through social messengers.
Category
N/A
2
Description
Control group :the usual postpartum care will be received, and a pamphlet including the usual postpartum sex counseling will be provided for them ,in addition to receiving routine care , at the end of the study, based on the obtained information, if couples in control group needs counseling, a counseling session will be held for them.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Center No. 12-Minoodar
Full name of responsible person
Hashem Alijani
Street address
Center No. 12 - Minodar , Behind the mosque , Dehkhoda Blvd , Dehkhoda square
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3379 4450
Fax
Email
mahhaid1371@gmail.com
Web page address
https://qums.ac.ir/
2
Recruitment center
Name of recruitment center
Center No. 8 - Nawab
Full name of responsible person
Hashem Alijani
Street address
Center No. 8 - Next to the former traffic light , The beginning of North Nawab St.,
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6889
Email
mahhaid1371@gmail.com
3
Recruitment center
Name of recruitment center
Pakrovan health center
Full name of responsible person
Hashem Alijani
Street address
Pakrovan health center, Next to Shahada Park, At the end of Heydari St.
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3332 4006
Email
mahhaid1371@gmail.com
4
Recruitment center
Name of recruitment center
Center No. 6- Waliasr
Full name of responsible person
Hashem Alijani
Street address
Center No. 6- Waliasr, Nabovat St., Beheshti Blvd
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3334 5057
Email
mahhaid1371@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Doctor Seyed Mahdi Mirhashemi
Street address
Qazvin University of Medical Sciences.,Shahid Bahonar Blvd.,Qazvin
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6001
Fax
+98 28 3332 4970
Email
medicine@qums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Sara Heydari
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.7-Peyman building., Andrezgoo 5th .,Andrezgoo St.
City
Saveh
Province
Markazi
Postal code
3918847835
Phone
+98 86 4241 4105
Fax
Email
mahhaid1371@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Sara Heydari
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Peyman building ., Andrezgo 5th ., Andrezgo St., Saveh
City
Saveh
Province
Markazi
Postal code
3418847835
Phone
+98 86 4241 4105
Fax
Email
mahhaid1371@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Sara Heydari
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Peyman building ., Andrezgo 5th ., Andrezgo St., Saveh
City
Saveh
Province
Markazi
Postal code
3418847835
Phone
+98 86 4241 4105
Fax
Email
mahhaid1371@gmail.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
None of the personal information of the samples can be accessed, but non-identifiable data and things like study protocol documentation, data analysis program will be shared.
When the data will become available and for how long
Year 1402
To whom data/document is available
Other researchers
Under which criteria data/document could be used
If permission is obtained from the authors of the work