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Protocol summary
A semi-experimental study is conducted using a parallel clinical trial method with two parallel groups (each group of 35 people) randomized without blinding on the anxiety and sexual intimacy of 70 qualified women. Sampling is done by simple random allocation method using randomization site.
A experimental study is conducted using a parallel clinical trial method with two parallel groups (each group of 35 people) randomized without blinding on the anxiety and sexual intimacy of 70 qualified women. Sampling is done by simple random allocation method using randomization site.
A semi-experimental study is conducted using a parallel clinical trial method with two parallel groups (each group of 35 people) randomized without blinding on the anxiety and sexual intimacy of 70 qualified women. Sampling is done by simple random allocation method using randomization site.
مطالعه از نوع نیمه تجربی، به روش کارآزمایی بالینی موازی دارای دو گروه موازی (هر گروه 35 نفر)تصادفی شده بدون کورسازی بر اضطراب و صمیمیت جنسی 70 زن واجد شرایط انجام می شود. نمونه گیری به روش تخصیص تصادفی ساده با استفاده از سایت راندومیزیشن انجام می شود.
مطالعه از نوع تجربی، به روش کارآزمایی بالینی موازی دارای دو گروه موازی (هر گروه 35 نفر)تصادفی شده بدون کورسازی بر اضطراب و صمیمیت جنسی 70 زن واجد شرایط انجام می شود. نمونه گیری به روش تخصیص تصادفی ساده با استفاده از سایت راندومیزیشن انجام می شود.
مطالعه از نوع نیمه تجربی، به روش کارآزمایی بالینی موازی دارای دو گروه موازی (هر گروه 35 نفر)تصادفی شده بدون کورسازی بر اضطراب و صمیمیت جنسی 70 زن واجد شرایط انجام می شود. نمونه گیری به روش تخصیص تصادفی ساده با استفاده از سایت راندومیزیشن انجام می شود.
Having a history of at least two recurrent pregnancy loss
Women aged 18-45 years
Not having major stress such as divorce and death of relatives in the last 3 months
Having a cellphone and access to the ITA internal messaging network
Being Iranian;
pregnancy
Having a mental illness under treatment
Substance abuse in himself or his spouse according to the patient
Concurrent participation in another study
Having a history of at least two recurrent pregnancy loss
Women aged 18-45 years
Not having major stress such as divorce and death of relatives in the last 3 months
Having a cellphone and access to the ITA internal messaging network
Being Iranian;
pregnancy
patient’s or her spouse’s affliction with serious psychological disorders such as severe depression and psychosis,
consumption of any drug affecting sexual relations by the patient or her spouse (self-reported),
history of participating in sexual health education and counseling sessions
Having a history of at least two recurrent pregnancy loss Women aged 18-45 years Not having major stress such as divorce and death of relatives in the last 3 months Having a cellphone and access to the ITA internal messaging network Being Iranian; pregnancy Having a mental illness under treatment Substance abuse in himselfpatient’s or hisher spouse according to’s affliction with serious psychological disorders such as severe depression and psychosis, consumption of any drug affecting sexual relations by the patient Concurrent participationor her spouse (self-reported), history of participating in another studysexual health education and counseling sessions
داشتن سابقه حداقل دو سقط مکرر
زنان با سن45-18سال
نداشتن استرس های بزرگ مانند طلاق و مرگ نزدیکان در 3 ماه گذشته
داشتن گوشی هوشمند و دسترسی به شبکه پیام رسان داخلی ایتا
ایرانی بودن;
بارداری
داشتن بیماری روانی تحت درمان
سوء مصرف مواد در خود یا همسر به گفته بیمار
شرکت همزمان در مطالعه دیگر
داشتن سابقه حداقل دو سقط مکرر
زنان با سن45-18سال
نداشتن استرس های بزرگ مانند طلاق و مرگ نزدیکان در 3 ماه گذشته
داشتن گوشی هوشمند و دسترسی به شبکه پیام رسان داخلی ایتا
ایرانی بودن;
بارداری
ابتلای بیمار یا همسرش به اختلالات روانی جدی مانند افسردگی شدید و روان پریشی،
مصرف هر گونه داروی مؤثر بر روابط جنسی توسط بیمار یا همسرش (به گفته بیمار)،
سابقه شرکت در جلسات آموزشی و مشاوره سلامت جنسی
داشتن سابقه حداقل دو سقط مکرر زنان با سن45-18سال نداشتن استرس های بزرگ مانند طلاق و مرگ نزدیکان در 3 ماه گذشته داشتن گوشی هوشمند و دسترسی به شبکه پیام رسان داخلی ایتا ایرانی بودن; بارداری داشتن بیماریابتلای بیمار یا همسرش به اختلالات روانی تحت درمان سوءجدی مانند افسردگی شدید و روان پریشی، مصرف مواد در خودهر گونه داروی مؤثر بر روابط جنسی توسط بیمار یا همسر همسرش (به گفته بیمار)، سابقه شرکت همزمان در مطالعه دیگرجلسات آموزشی و مشاوره سلامت جنسی
General information
The intervention is finish
The intervention is finish.
Hello. Two minor items were edited to match the intervention performed.
The intervention is finish. Hello. Two minor items were edited to match the intervention performed.
مداخله به اتمام رسیده است
مداخله به اتمام رسیده است
باسلام. دو مورد جزئی به دلیل مطابقت با مداخله انجام شده ویرایش شد.
مداخله به اتمام رسیده است باسلام. دو مورد جزئی به دلیل مطابقت با مداخله انجام شده ویرایش شد.
Pregnancy
Having a mental illness under treatment
Substance abuse in himself or his wife according to the patient
Simultaneous participation in another study
Pregnancy
patient’s or her spouse’s affliction with serious psychological disorders such as severe depression and psychosis
consumption of any drug affecting sexual relations by the patient or her spouse (self-reported)
history of participating in sexual health education and counseling sessions
Pregnancy Having a mental illness under treatment Substance abuse in himselfpatient’s or his wife according toher spouse’s affliction with serious psychological disorders such as severe depression and psychosis consumption of any drug affecting sexual relations by the patient Simultaneous participationor her spouse (self-reported) history of participating in another studysexual health education and counseling sessions
بارداری
داشتن بیماری روانی تحت درمان
سوء مصرف مواد در خود یا همسر به گفته بیمار
شرکت همزمان در مطالعه دیگر
بارداری
ابتلای بیمار یا همسرش به اختلالات روانی جدی مانند افسردگی شدید و روان پریشی
مصرف هر گونه داروی مؤثر بر روابط جنسی توسط بیمار یا همسرش (به گفته بیمار)
سابقه شرکت در جلسات آموزشی و مشاوره سلامت جنسی
بارداری داشتن بیماریابتلای بیمار یا همسرش به اختلالات روانی تحت درمان سوءجدی مانند افسردگی شدید و روان پریشی مصرف مواد در خودهر گونه داروی مؤثر بر روابط جنسی توسط بیمار یا همسر همسرش (به گفته بیمار) سابقه شرکت همزمان در مطالعه دیگرجلسات آموزشی و مشاوره سلامت جنسی
Protocol summary
Study aim
Comparison of the effect of online problem-solving-based sexual counseling on anxiety and sexual intimacy in women with recurrent pregnancy loss
Design
A experimental study is conducted using a parallel clinical trial method with two parallel groups (each group of 35 people) randomized without blinding on the anxiety and sexual intimacy of 70 qualified women. Sampling is done by simple random allocation method using randomization site.
Settings and conduct
In the recurrent pergnancy loss clinic of Yazd Reproductive Medicine Research Institute, invitation to study, sample selection, random allocation and psychological intervention are carried out by the second researcher under the supervision of the first, third and fourth researchers.
Participants/Inclusion and exclusion criteria
Having a history of at least two recurrent pregnancy loss
Women aged 18-45 years
Not having major stress such as divorce and death of relatives in the last 3 months
Having a cellphone and access to the ITA internal messaging network
Being Iranian;
pregnancy
patient’s or her spouse’s affliction with serious psychological disorders such as severe depression and psychosis,
consumption of any drug affecting sexual relations by the patient or her spouse (self-reported),
history of participating in sexual health education and counseling sessions
Intervention groups
For the intervention group, 8 training sessions will be held online using voice and the possibility of questions and answers with private chat in the internal messaging network of ITA based on the developed program, and the control group will have the same sessions in the form of pamphlets and the possibility of questions and They will receive an answer with a phone call
Main outcome variables
Change in mean scores of anxiety and sexual intimacy
General information
Reason for update
The intervention is finish.
Hello. Two minor items were edited to match the intervention performed.
Acronym
IRCT registration information
IRCT registration number:IRCT20220620055229N1
Registration date:2023-02-14, 1401/11/25
Registration timing:prospective
Last update:2024-04-10, 1403/01/22
Update count:2
Registration date
2023-02-14, 1401/11/25
Registrant information
Name
Shahla Mohammadkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3724 0171
Email address
sh.mohamadkhani76@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-04, 1401/11/15
Expected recruitment end date
2023-04-27, 1402/02/07
Actual recruitment start date
2023-03-06, 1401/12/15
Actual recruitment end date
2023-08-06, 1402/05/15
Trial completion date
2023-08-11, 1402/05/20
Scientific title
Investigating the effect of sexual counseling based on online problem solving on anxiety and sexual intimacy in women with recurrent pregnancy loss
Public title
Investigating sexual counseling based on online problem solving on anxiety and sexual intimacy in women with recurrent pregnancy loss
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a history of at least two recurrent pregnancy loss
Women aged 18-45 years
Not having major stress such as divorce and death of relatives in the last 3 months
Having a Cellphone and access to ITA's internal messenger network
Being Iranian
Exclusion criteria:
Pregnancy
patient’s or her spouse’s affliction with serious psychological disorders such as severe depression and psychosis
consumption of any drug affecting sexual relations by the patient or her spouse (self-reported)
history of participating in sexual health education and counseling sessions
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:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The first-generation random allocation method was used to assign the eligible participants into two intervention and active control groups, each participant was given a number from 1 to 70.
Then, using the website http://www.randomization.com. participants were randomly assigned into two blocks of 35, C and D. A person external to the study used a random lottery method to select each block as an intervention or active control group.
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 Committee of Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Yazd, Bahnar Ave
City
Yazd
Province
Yazd
Postal code
8916189165
Approval date
2023-01-24, 1401/11/04
Ethics committee reference number
IR.SSU.REC.1401.067
Health conditions studied
1
Description of health condition studied
Sexual dysfunction counseling
ICD-10 code
N96
ICD-10 code description
Recurrent pregnancy loss
Primary outcomes
1
Description
Change in mean sexual anxiety scores
Timepoint
Baseline, end of intervention in week 8 and end of intervention in week 12
Method of measurement
Sexual anxiety Index (Davis et al.)
Secondary outcomes
1
Description
Change in mean sexual intimacy scores
Timepoint
Baseline, end of intervention in week 8 and end of intervention in week 12
Method of measurement
Sexual Intimacy Index (Bagarouzi et al.)
Intervention groups
1
Description
Intervention group: For the intervention group, 8 training sessions will be held online using voice and the possibility of questions and answers with private chat on the internal messaging network of ITA based on the program developed by the second researcher and under the supervision of the first and third researchers. The content of the sessions Includes: explanations about the terms sexual anxiety, sexual intimacy, frequent abortion and problem solving approach, teaching logical problem solving and defining the problem clearly and objectively, setting achievable and realistic goals to solve the problem, learning functional ABCs, training Effective problem solving in real life is through combining emotions and logical thinking, choosing the best solution, evaluating and reviewing. At the beginning of each session, a summary of the previous sessions will be reviewed and the assigned tasks related to the previous session will be reviewed by the researcher. they turn Women are asked to participate in discussions and raise their questions. At the end of each session, a summary of the important topics discussed is presented and people's questions are answered, and women are asked to do their homework in the next sessions.
Category
Behavior
2
Description
Control group: The control group will receive 8 sessions of problem solving advice in the form of pamphlets and the possibility of questions and answers by telephone. The content of the sessions includes explanations about the terms sexual anxiety, sexual intimacy, frequent abortion and problem solving approach, teaching logical problem solving and defining the problem clearly and objectively, setting achievable and realistic goals to solve the problem, learning functional ABCs, Teaching effective real-life problem solving through combining emotions and logical thinking, choosing the best solution, evaluating and revising
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Reproductive Medicine Research Institute of Yazd repeated abortion clinic
Full name of responsible person
mahshid bokaie
Street address
Bu Ali Ave
City
yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 7085
Email
mah-bokaie@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Alireza Moradi
Street address
Yazd, Dr. Bahnar Ave, Central Organization of Shahid Sadoughi University of Medical Sciences, Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 2637 3337
Fax
+98 35 2637 3237
Email
alirezampr@gmail.com
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
mahshid bokaie
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Yazd, Bu Ali Ave
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 2438 5117
Email
mah-bokaie@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
mahshid bokaie
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Yazd, Bu Ali Ave
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 2438 5117
Email
mah-bokaie@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
mahshid bokaie
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Bu Ali Ave
City
yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 2438 5117
Email
mah-bokaie@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All personal data of participants can be shared after de-identification.
When the data will become available and for how long
After printing the results
To whom data/document is available
The data will be available for researchers working in academic and scientific institutions, and people working in the industry can apply to receive them.
Under which criteria data/document could be used
Scientific use
From where data/document is obtainable
mah-bokaie@yahoo.com
What processes are involved for a request to access data/document