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The effect of virtual based cognitive-behavioral sexual counseling on sexual function, satisfaction and intimacy in pregnant women

Protocol summary

Study aim
Determining the effect of virtual cognitive behavioral sexual counseling on sexual function, satisfaction and intimacy of pregnant women
Design
The study will be performed on 80 pregnant women who are randomly divided into intervention and control groups. Block randomization will be used for randomization using internet tools.
Settings and conduct
Sampling is done in comprehensive health centers and bases in Alborz province. First, a list of all comprehensive health centers and bases in Alborz province is prepared and ten centers that are suitable in terms of the number of pregnancy coverage are selected. preliminary sampling will be available in such a way that the researcher will contact the eligible people using the phone number in the file and giving explanations about the goals. Eligible volunteers are placed on a list with a row number.Block randomization is used for random allocation, so that the online block randomization tool will be used.
Participants/Inclusion and exclusion criteria
Sexual function score less than 28, first pregnancy, age 18 to 35 years, singleton and desire, gestational age 16 to 24 weeks, low risk pregnancy, internet literacy, absence of sexual dysfunction in the spouse, no severe mental illness, no grief in the three months before the study, no attending similar treatment sessions in the last six months
Intervention groups
This study will be performed on 80 pregnant women in comprehensive health centers who are eligible to enter the study. First, participants will be divided into two groups of intervention and control. Then, the members of the intervention group participate in 8 sessions of group sexual counseling virtually, and the control group is placed under the usual care of the health center.
Main outcome variables
The primary variables are sexual function and secondary outcome variables are sexual satisfaction and intimacy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161230031662N10
Registration date: 2021-06-21, 1400/03/31
Registration timing: registered_while_recruiting

Last update: 2021-06-21, 1400/03/31
Update count: 0
Registration date
2021-06-21, 1400/03/31
Registrant information
Name
Razieh Lotfi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3430 4433
Email address
raziehlotfi@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-20, 1400/02/30
Expected recruitment end date
2021-07-21, 1400/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of virtual based cognitive-behavioral sexual counseling on sexual function, satisfaction and intimacy in pregnant women
Public title
The effect of sexual counseling on sexual function in pregnant women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Sexual function score less than 28 First pregnancy Single pregnancy Wanted pregnancy Gestational age 16 to 24 weeks Low risk pregnancy Having access to a phone with Android operating system Internet literacy Age 18 to 35 years No grief in the three months before the study Living with a spouse
Exclusion criteria:
High risk pregnancies such as placenta previa, threatened miscarriage, gestational hypertension, gestational diabetes and high risk screening Smoking and drinking alcohol Use of drugs and drugs that affect sexual response Sexual dysfunction in the spouse Severe mental illness Attend similar treatment sessions for the past six months
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method is used in the present study. This will be done using a random block internet tool via http://www.sealedenvelope.com/simple-randomiser/v1/lists. Block size is determined 4 and allocation was done upon arranges of codes in the blocks. Randomization will concealed in sequentially numbered, sealed, opaque envelopes. After producing randomization sequence, 80 opaque envelopes will be provided and each randomization sequence is recorded on a card, then placed in the envelope in order. To keep concealment, envelopes are numbered too. The envelope is sealed and placed in a box in order. At the beginning of the registration of participants, according to the order of entry of eligible participants to study, one of the envelopes will be opened and the assigned group of the participant will be determined.
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 Alborz university of medical sciences
Street address
Alborz University of Medical Sciences, Shahrake Edari, North Taleghani, Azimieh, Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2021-04-26, 1400/02/06
Ethics committee reference number
IR.ABZUMS.REC.1400.023

Health conditions studied

1

Description of health condition studied
Pregnancy
ICD-10 code
Z70.0
ICD-10 code description
Counseling related to sexual attitude

Primary outcomes

1

Description
Sexual function score in Rosen's female sexual performance questionnaire
Timepoint
In two turns, before the study begins and four weeks after the end of intervention
Method of measurement
Rosen women's sexual function questionnaire

Secondary outcomes

1

Description
Sexual satisfaction score in the Larson questionnaire
Timepoint
At the beginning of the study and four weeks the end of the study
Method of measurement
Larson sexual satisfaction questionnaire

2

Description
Sexual intimacy score in the in the Botlani questionnaire
Timepoint
At the beginning of the study and four weeks after the end of the study
Method of measurement
Botlani sexual intimacy questionnaire

Intervention groups

1

Description
Intervention group: Eight weekly 90-minute group sex counseling sessions with virtual content based on cognitive behavioral therapy. First, a group will be formed in one of the messaging systems and research samples will be added to it. The studied samples will be included in the Telegram group. The intervention group will then be divided into three groups to participate in Skyroom classes. A 90-minute session is held weekly for each group. The content of the sessions will be prepared by preparing educational PowerPoint, Weiss, and educational video according to the layout designed in the session table in cooperation with and under the supervision of supervisors and counselors who are sufficiently proficient in sexual issues and sexual cognitive-behavioral counseling. Practice and homework on the taught material will be given at the end of the sessions and in the next sessions the homework will be reviewed. The content of all meetings will be recorded and will be uploaded to the Telegram channel for future reviewed and study for absents. The questions and problems of the samples will be answered individually by the researcher. Depending on the content of each session, text, audio, video or online classes will be used. Content of training sessions including: introduction and familiarity with treatment methods, anatomy and physiology, sexual cycle of men and women-Review and explanation of areas of sexual function and its changes during pregnancy, training and practice of emotions and behavior and training in relaxation, study of emotions, thoughts and sexuality dysfunctional behavior during pregnancy-cognitive errors,explaining the pattern of sexual changes during pregnancy, Practicing sexual fantasies-Rational alternatives, description of different position of intimacy during pregnancy, relaxation exercises and Kegel-exercises to change dysfunctional sexual thoughts, Definition of intimacy and its dimensions, Teaching how to establish intimacy, factors affecting sexual satisfaction and concentration, effective communication and greater participation-Review of teaching sexual relations techniques and answering questions.
Category
Behavior

2

Description
Control group: 40 pregnant women just receive routine prenatal care
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Fajr Health Center
Full name of responsible person
Manizheh Fathalian
Street address
Milad 1 Alley, Emam Khomeini Street
City
Kamalshahr
Province
Alborz
Postal code
3149779453
Phone
+98 26 3470 3204
Fax
Email
mahtab.fathi358@gmail.com
Web page address

2

Recruitment center
Name of recruitment center
Valiasr Health Center
Full name of responsible person
Manizheh Fathalian
Street address
Meysam 2, Khoramdasht Town
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3480 5863
Email
mahtab.fathi358@gmail.com
Web page address

3

Recruitment center
Name of recruitment center
Amuzgar Health Center 1
Full name of responsible person
Manizheh Fathalian
Street address
No 7, Khazeni Alley, Emamreza Street
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3730 7590
Email
mahtab.fathi358@gmail.com

4

Recruitment center
Name of recruitment center
Golzar Health Center 2
Full name of responsible person
Manizheh Fathalian
Street address
Golzar gharbi Street, 45 metri Golshahr
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3351 5758
Email
mahtab.fathi358@gmail.com

5

Recruitment center
Name of recruitment center
Aadl Health Center 2
Full name of responsible person
Manizheh Fathalian
Street address
No 511, Bahar Building, Emamhosein Square, Shahin vila
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3453 1814
Email
mahtab.fathi358@gmail.com

6

Recruitment center
Name of recruitment center
Zafar Health Center 1
Full name of responsible person
Manizheh Fathalian
Street address
Miad 26, Emamkhomeini Street, Kamalshahr
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3470 1408
Email
mahtab.fathi358@gmail.com

7

Recruitment center
Name of recruitment center
Valad abad bozorg Health Center 2
Full name of responsible person
Manizheh Fathalian
Street address
Roberoye Chamran 1, Emamkhomeini Boulvar, Mohamad shahr
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3631 3437
Email
mahtab.fathi358@gmail.com

8

Recruitment center
Name of recruitment center
Anbari Health Center
Full name of responsible person
Manizheh Fathalian
Street address
Kianpoor Street, Mesbah Street, Emamzadehhasan Boulvar
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3280 4070
Email
mahtab.fathi358@gmail.com

9

Recruitment center
Name of recruitment center
Aghtapeh Health Center
Full name of responsible person
Manizheh Fathalian
Street address
Valiasr Street, Panjome shatghi Street, Eram Boulvar, Mehrshahr
City
Mehrshahr
Province
Alborz
Postal code
314779453
Phone
+98 26 3330 9001
Fax
Email
mahtab.fathi358@gmail.com

10

Recruitment center
Name of recruitment center
Comprehensive Health Center of Hesarak
Full name of responsible person
Manizheh Fathalian
Street address
Shahid Khorasani Street, Shahid Beheshti Street
City
Karaj
Province
Alborz
Postal code
314779453
Phone
+98 26 3456 5667
Email
mahtab.fathi358@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research Alborz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Noorisepehr
Street address
North Taleghani Street, Azimieh, Karaj
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 4255
Email
dr.noorisepehr@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Alborz 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
Karaj University of Medical Sciences
Full name of responsible person
Manizheh Fathalian
Position
BsC in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Medicine, University of Medical Sciences Campus, University of Art, End of West Bou Ali Street, Nobovvat Square, Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3419 7685
Email
mahtab.fathi358@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Razieh Lotfi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
1st Golestan Street, South Eshteraki Boulevard, Baghestan, Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 912 765 5855
Email
Lotfi_razieh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Manizheh Fathalian
Position
BCs in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Medicine, University of Medical Sciences Campus, University of Art, End of West Bou Ali Street, Nobovvat Square, Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3419 7685
Email
mahtab.fathi358@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
Not applicable
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
Total potential data can be shared after unidentifiable people
When the data will become available and for how long
Data will be in access 6 months after publishing the results
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Scientific studies
From where data/document is obtainable
Using Email Address: marmarmzf@gmail.com
What processes are involved for a request to access data/document
Up to a week after sending the email address
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