Effectiveness of online and face to face positive psychology counseling on sexual intimacy in women undergoing hysterectomy due to benign reasons.
Design
The study is a randomized clinical trial with parallel groups without blinding and it is conducted on 66 eligible women with a history of vaginal hysterectomy. Simple randomization is done based on the output of the Random Allocation software.
Settings and conduct
The research environment is the Shohadaye Kargar Hospital in Yazd and the selection of samples from women eligible for random allocation and positive counseling intervention is carried out by the second researcher under the supervision of the first, third and fourth researchers. Face-to-face counseling sessions at the sampling site and virtual counseling sessions through The virtual network software is Iranian version.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 20 and 60 years. The cause of hysterectomy is benign. The type of hysterectomy should be complete abdominal. Three months to two years have passed since the hysterectomy. Have a common bed with her husband. Be the only wife of her husband Have access to a smart phone and the Internet.
Non-entry criteria: Participation in psychological and psychiatric interventions at the same time. taking psychiatric drugs (according to the patient). Have done a vaginal hysterectomy.She or her husband have addiction (according to the patient)
Intervention groups
For the virtual intervention group, 8 sessions of 90 minutes with an interval of one week will be held virtually in line with education (positive approach in sexual relations). And for the face-to-face intervention group, training will be held in the form of 8 sessions of 90 minutes based on (positive-oriented approach in sexual relations) once a week at the sampling center in person.
Main outcome variables
Sexual intimacy score.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230209057373N1
Registration date:2023-04-19, 1402/01/30
Registration timing:prospective
Last update:2023-04-19, 1402/01/30
Update count:0
Registration date
2023-04-19, 1402/01/30
Registrant information
Name
Orly Nazanin Kalimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3825 8404
Email address
o.nazaninkalimi@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-05, 1402/02/15
Expected recruitment end date
2023-07-06, 1402/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of online and face to face positive psychology counseling on sexual intimacy in women undergoing hysterectomy due to benign reasons.
Public title
Effectiveness of online and face to face positive psychology counseling on sexual intimacy in women undergoing hysterectomy due to benign reasons.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 and 60 years
The cause of hysterectomy is benign
The type of hysterectomy should be complete abdominal
Three months to two years have passed since the hysterectomy.
Have a common bed with her husband
Be the only wife of her husband
Have access to a smart phone and the Internet.
Exclusion criteria:
Participation in psychological and psychiatric interventions at the same time
taking psychiatric drugs (according to the patient).
Have done a vaginal hysterectomy.
She or her husband have addiction (according to the patient)
Age
From 20 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
66 women with a history of hysterectomy have a record of hospitalization in Shohadaye Kargar Hospital of Yazd and are included in the study based on the entry and exit criteria.Sampling in this research will be done by simple random allocation method.So that by the expert of biostatistics using simple randomization method and sequence of random numbers with random allocation software, these women are divided into two groups of 33 people: virtual positive counseling (intervention group) and face-to-face positive counseling (control group). At the beginning of the study, people are told that they have the same chance to be in each intervention group. And except for the biostatistics researcher, no one (not the students, supervisors and advisors and not the participants) knows in which group they will be allocated.
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
Street address
Shahid Sadoughi University of Medical Sciences, Shahid Bahonar Bld., Yazd
City
Yazd
Province
Yazd
Postal code
8916189165
Approval date
2023-01-24, 1401/11/04
Ethics committee reference number
IR.SSU.REC.1401.080
Health conditions studied
1
Description of health condition studied
Sexual intimacy counseling
ICD-10 code
Z70.8
ICD-10 code description
Other sex counselling
Primary outcomes
1
Description
Change in mean scores of sexual intimacy in women
Timepoint
Measuring the sexual intimacy score at the beginning of the study (before the start of the intervention) and 8 and 12 weeks after the start of virtual and face-to-face counseling
Method of measurement
Women's Sexual Intimacy Questionnaire (Botlani et al.)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The virtual counseling group is subjected to the protocol of counseling and question and answer during 8 counseling sessions for 90 minutes, a positive approach in sexual relations where both the content of the sessions are presented and the questions are answered. Counseling by a researcher who is studying counseling in midwifery and has obtained the certificate of ability to complete the positive-oriented approach counseling course under the supervision of supervisors, the counselor is implemented. In the intervention group, there are 8 virtual group counseling sessions of 90 minutes, the content of the positive-oriented approach sessions with The subject of the effect of a positive cognitive approach on sexual satisfaction and marital compatibility, which has been approved by supervisors, advisors, referees, and supervisors, is prepared in a multimedia format and one day a week in a virtual way by installing one of the software The authorized messengers are carried out on mobile phones of the research units and they are asked to ask their questions in the form of online chat and receive the necessary advice and guidance from the researcher.
Category
Behavior
2
Description
Control group: the face-to-face intervention or control group, the content of the sessions is the same as the virtual intervention group, with the difference that one session per week is held as a group according to the planning between the researcher and the clients by the researcher at Shohada Karegar Hospital. In the control group, there were 8 face-to-face group counseling sessions, 90 minutes, with the content of the positive approach sessions on the topic of the effect of the positive cognitive approach on sexual satisfaction and marital adjustment by a researcher who studies counseling in midwifery and a certificate of ability to complete the positive approach counseling course. It is implemented under the supervision of supervisors and advisors.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada-ye Kargar Hospital, Yazd
Full name of responsible person
Mahshid Bokaie
Street address
School of Midwifery Nursing., Bouali Alley., Teymsar Fallahi St., Safaieh., Yazd
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Fax
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
Central Organization of Shahid Sadoughi University of Medical Sciences, Yazd,Dr. Bahonar Square,Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Fax
+98 35 3726 3732
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
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Midwifery Nursing., Bouali Alley., Teymsar Fallahi St., Safaieh., Yazd
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
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
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Midwifery Nursing., Bouali Alley., Teymsar Fallahi St., Safaieh., Yazd
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
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
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Midwifery Nursing., Bouali Alley., Teymsar Fallahi St., Safaieh., Yazd
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
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 individual data of study participants can be shared after de-identification.
When the data will become available and for how long
After results publication.
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions, and people working in industry can apply to receive them
Under which criteria data/document could be used
Scientific usage.
From where data/document is obtainable
mah_bokaie@yahoo.com
What processes are involved for a request to access data/document