Protocol summary

Study aim
Comparison of emotion-based couple therapy based on Islamic perspective and sexual health education on sexual intimacy of pregnant women
Design
Clinical trial with control group, parallel groups, randomized on 52 pregnant women. Use random number table and spss software for randomization
Settings and conduct
Sampling from Amir Yazd Social Security Clinic and virtual counseling sessions is done through the Iranian version of the virtual network software.
Participants/Inclusion and exclusion criteria
Admission requirement: with a smartphone and a pregnancy record of more than 20 weeks, Shia, obtaining a score of invalidity questionnaire less than 100 Exclusion criteria: History of alcohol, tobacco and drugs that affect sexual desire such as antidepressant and antihypertensive, according to the mother, receiving interventions related to couple therapy in the last 6 months.
Intervention groups
Using a table of random numbers of pregnant women are divided into two groups. The first group of the intervention under the counseling of emotion-oriented couple therapy is virtual and the second group, which is the control group, is under the virtual sexual health training package. Meetings of the two groups are held in parallel, each lasting 6 sessions of 90 minutes. Finally, the effectiveness of counseling on sexual intimacy of pregnant women is examined.
Main outcome variables
Sexual intimacy of pregnant women Satisfaction of pregnant women with the interventions performed

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200112046091N1
Registration date: 2020-10-02, 1399/07/11
Registration timing: prospective

Last update: 2020-10-02, 1399/07/11
Update count: 0
Registration date
2020-10-02, 1399/07/11
Registrant information
Name
Zahra Masaeli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 1751
Email address
masaelizahra485@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-24, 1399/08/03
Expected recruitment end date
2020-10-29, 1399/08/08
Actual recruitment start date
2020-10-24, 1399/08/03
Actual recruitment end date
2020-10-29, 1399/08/08
Trial completion date
2021-02-07, 1399/11/19
Scientific title
.The Effectiveness Comparison of Emotion-Focused Therapy Based on Islamic view and Sexual Health Education on Sexual Intimacy in Pregnant Women
Public title
"Comparison of Emotion-Focused Therapy Based on Islamic View in Pregnant Women"; "Sexual Health Education in Pregnant Women";
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Married pregnant mothers Gestational age of at least 24-20 weeks based on first trimester ultrasound and pregnancy record Iranian ethnicity and resident of Yazd Muslims and Shiites and having religious beliefs Have minimal literacy Interest in attending counseling sessions and not attending the same study at the same time Obtain a score of less than 100 invalid questionnaires Healthy pregnant mother based on pregnancy file Conscious satisfaction and willingness to participate in research Having a smartphone and internet literacy (skills of using cyberspace like WhatsApp)
Exclusion criteria:
History of alcohol and tobacco use and drugs that affect sexual desire, such as Anti-Depressant and Anti-Hypertensive, according to the mother Receive couples therapy interventions in the last 6 months
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 52
Actual sample size reached: 52
Randomization (investigator's opinion)
Randomized
Randomization description
Using a table of computer random numbers, the researcher first determined the framework of his statistical community and determined the exact number of people in the community, which was 52 people, and assigned a code to them, and placed the numbers in a table with rows and columns. . The researcher placed a finger or the tip of a pen on the table to select the sample people with their eyes closed. The movement in the direction of the row or column did not matter and was at the request of the researcher. The number selected was the individual code of the community that was selected as the sample. Each code was randomly assigned to an emotion-driven virtual counseling or sex education group until the sample size of each group was 26. Final samples are called at a specific location. The purpose, method of work and the right to participate or not to participate in the research were explained to them. Samples who did not want to attend the sessions were excluded from the study. Then the required number of samples (26 people for each group) were selected. Again, we divided the people of each group into two groups of thirteen (B and A) by tossing a coin, so that if the surface of the lion was visible, it belonged to group A, and if the surface of the line was visible, it belonged to group B.
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 Shahid Sadoughi University of Medical Sciences, Yazd
Street address
School of Midwifery Nursing., Bouali Alley., Teymsar Fallahi St., Safaieh., Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۸۷۷۴۴۳
Approval date
2020-01-06, 1398/10/16
Ethics committee reference number
IR.SSU.REC.1398.169

Health conditions studied

1

Description of health condition studied
Sexual intimacy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The percentage of people whose sexual intimacy score is below 100 is invalid
Timepoint
Measurement of sexual intimacy score at the beginning of the study (before the intervention) and 6 and 10 weeks after the start of online counseling
Method of measurement
Invalid sexual intimacy questionnaire

Secondary outcomes

1

Description
Satisfaction scores from the counseling method
Timepoint
Determining and comparing the mean scores of satisfaction with the counseling method at the end of the sixth week and the end of the tenth week of the intervention in the two groups
Method of measurement
Satisfaction Questionnaire

Intervention groups

1

Description
"Intervention group:" 26 pregnant women in the intervention group who are in absentia (online) under the emotional counseling based on the Islamic perspective are given weekly in 6 sessions of 90 minutes.
Category
Behavior

2

Description
Control group: 26 people in the control group who receive offline (online) sexual health training on a weekly basis for 6 sessions of 90 minutes.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir Yazd Social Security Clinic
Full name of responsible person
Farajkhoda Tahmineh
Street address
School of Midwifery Nursing., Bouali Alley., Teymsar Fallahi St., Safaieh., Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۸۷۷۴۴۳
Phone
+98 35 3824 1751
Fax
+98 35 3824 9705
Email
z.masaeli@stu.ssu.ac.ir
Web page address
https://web.ssu.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Reza Malekzadeh
Street address
School of Midwifery Nursing., Bouali Alley., Teymsar Fallahi St., Safaieh., Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۸۷۷۴۴۳
Phone
+98 35 3824 1751
Fax
+98 35 3824 9705
Email
z.masaeli@stu.ssu.ac.ir
Web page address
https://web.ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Farajkhoda Tahmineh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Midwifery Nursing., Bouali Alley., Teymsar Fallahi St., Safaieh., Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۸۷۷۴۴۳
Phone
+98 35 3824 1751
Fax
+98 35 3824 9705
Email
t.farajkhoda@ssu.ac.ir
Web page address
https://web.ssu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Farajkhoda Tahmineh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Midwifery Nursing., Bouali Alley., Teymsar Fallahi St., Safaieh., Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۸۷۷۴۴۳
Phone
+98 35 3824 1751
Fax
+98 35 3824 9705
Email
t.farajkhoda@ssu.ac.ir
Web page address
https://web.ssu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Farajkhoda Tahmineh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Midwifery Nursing., Bouali Alley., Teymsar Fallahi St., Safaieh., Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۸۷۷۴۴۳
Phone
+98 35 3824 1751
Fax
+98 35 3824 9705
Email
t.farajkhoda@ssu.ac.ir
Web page address
https://web.ssu.ac.ir

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
Loading...