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Investigating the effect of sexual mindfulness-based training on sexual function and sexual well-being in women with breast cancer:A Randomized Clinical Trial

Protocol summary

Study aim
Determining the effect of sexual mindfulness-based training on sexual performance and sexual well-being in women with breast cancer
Design
Clinical trial with intervention and control groups, one blind strain, on 30 qualified women with breast cancer who were selected as available and with knowledge of the purpose and method of conducting the study, in two groups of 15 people, are randomly assigned.
Settings and conduct
In the first stage, after obtaining permission from the Ethics Committee of Shahrekord University of Medical Sciences, the researcher will go to the Alla Cancer Prevention and Control Center (Maxa), located in Isfahan city, to collect samples and conduct a targeted sampling of eligible women. In the next step, 30 eligible women with breast cancer were selected as available and after obtaining informed consent from them, they were randomly assigned to two intervention and control groups.The intervention group received sexual mindfulness training in 8 sessions, once a week, and in the meantime, the members of the control group did not receive any intervention. Before, immediately and three months later, both groups were given questionnaires of indicators of sexual performance and well-being. One-way blinding process is possible for this research Finally, the obtained data will be analyzed with SPSS software version 24.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Being sexually active Not having sexual dysfunction before cancer and... Exclusion criteria: major depression
Intervention groups
The members of the intervention group are trained in sexual mindfulness in 8 90-minute sessions by the researcher and with the cooperation of a clinical psychologist. The control group does not undergo any training in these 8 weeks and only completes the questionnaire.
Main outcome variables
Sexual mindfulness.sexual function. Sexual well-being.breast cancer

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230416057924N1
Registration date: 2024-02-13, 1402/11/24
Registration timing: retrospective

Last update: 2024-02-13, 1402/11/24
Update count: 0
Registration date
2024-02-13, 1402/11/24
Registrant information
Name
Asefeh Shirdashtzadeh kerdabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 1272 3993
Email address
st-shirdasht.a@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-10, 1402/10/20
Expected recruitment end date
2024-02-09, 1402/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of sexual mindfulness-based training on sexual function and sexual well-being in women with breast cancer:A Randomized Clinical Trial
Public title
Investigating the effect of sexual mindfulness-based training on sexual function and sexual well-being in women with breast cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least elementary education Iranian citizenship Definite diagnosis of breast cancer (pathological diagnosis) Informed consent to participate in the study Being sexually active Being single and living with a spouse now and during the study Not having sexual dysfunction before of cancer Absence of acute psychiatric disorders and use of related drugs Passing at least 3 months of conventional cancer treatments
Exclusion criteria:
Failure to participate in 2 or more sessions during the research period Using consulting services outside of research Divorce or death of spouse during the study period Existence of systemic or chronic disorders and any debilitating diseases such as heart disease, diabetes, etc Any use of sedatives, alcohol, psychotropic substances and drugs Diagnosing metastasis or disease recurrence Unwillingness to continue cooperation major depression
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
One-way blinding process is possible for this research. In this way, in the final analysis, the statistical analyst of the groups The intervention and control are uninformed and the data of the groups with letters A and B is named
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of shahrekord university of medical sciences
Street address
Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Approval date
2023-08-15, 1402/05/24
Ethics committee reference number
IR.SKUMS.REC.1402.060

Health conditions studied

1

Description of health condition studied
Breast cancer
ICD-10 code
C50.9
ICD-10 code description
Malignant neoplasm of breast of unspecified site

Primary outcomes

1

Description
Sexual well-being
Timepoint
Start of the intervention - immediately and three months after the intervention
Method of measurement
Based on the scores obtained from the women's sexual well-being questionnaire:( Fsws scale)

2

Description
Sexual function
Timepoint
Start of the intervention - immediately and three months after the intervention
Method of measurement
( Female Sexual Function Index-FSFI)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: The members of the intervention group are trained in sexual mindfulness in 8 90-minute sessions by the researcher in collaboration with a clinical psychologist. Meetings are held once a week in person.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
“Iranian Cancer Control Center” (MACSA)
Full name of responsible person
Homayun Naji Esfahani
Street address
No. 29 Amin-o-Doleh Blind Alley, 35th Alley, Motahari St.
City
Esfahan
Province
Isfehan
Postal code
۸۱۸۴۹۳۳۴۷۳
Phone
+98 31 3233 3029
Fax
+98 31 3233 1051
Email
info@macsa.ir
Web page address
https://macsa.ir/fa/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Elham Raeisi
Street address
Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷
Phone
+98 38 3333 0065
Email
info@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
40
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
Shahre-kord University of Medical Sciences
Full name of responsible person
Asefeh shirdashtzaeh
Position
master of midwifery student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
1st floor, No. 34, Shahid Ziyai Alley, Bozormehr St
City
Esfahan
Province
Isfehan
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 31 3272 3993
Email
st-shirdasht.a@skums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Fereshteh Rasti Borujeni
Position
Assistant Professor of Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
038-33330061-5
Email
drfrasti@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Asefeh shirdasht zadeh
Position
master of midwifery student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 34, first floor, Shahid Ziyai alley, Bozormehr St., Arasteh St
City
Esfahan
Province
Isfehan
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 31 3272 3993
Email
st-shirdasht.a@skums.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
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