Determining the effectiveness of cognitive therapy counseling based on mindfulness on sexual satisfaction and distress of married women with periodic mastalgia.
Design
Randomized controlled clinical trial, with parallel groups, randomized, on 72 married women with periodic breast pain in the comprehensive health centers of Qazvin city, and the four block method is used for random allocation. In order to determine the sequence of allocation by the block method of four, random allocation sequence generation software is used.
Settings and conduct
This study is conducted on 72 married women suffering from periodic breast pain in health community centers of Qazvin city, and cognitive therapy counseling based on mindfulness is provided to them individually and virtually during eight sessions of approximately two hours, and the first session In order to get to know and explain the objectives of the research, it is in person.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having breast pain for more than 5 days per month according to the Cardiff breast pain table and pain intensity greater than 4 in every 5 days according to the objective pain ruler; Married women
Exclusion criteria: having marital conflicts based on the person's statement; pregnancy; breastfeeding
Intervention groups
Cognitive therapy based on mindfulness will be planned in the form of eight approximately two-hour sessions and will be held virtually twice a week.
The control group will also receive routine care and no intervention will be done for them. At the end of the study, the prepared files will be provided to them, and if necessary, a counseling session will be held for them.
Main outcome variables
Primary outcomes: sexual satisfaction; sexual distress; Mindfulness
Secondary outcome: severity of breast pain
General information
Reason for update
Acronym
MBCT
IRCT registration information
IRCT registration number:IRCT20240520061847N1
Registration date:2024-08-21, 1403/05/31
Registration timing:prospective
Last update:2024-08-21, 1403/05/31
Update count:0
Registration date
2024-08-21, 1403/05/31
Registrant information
Name
elnaz abedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3366 1768
Email address
elnazabedi13780@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of mindfulness based cognitive therapy on sexual satisfaction and distress of married women with cyclic mastalgia
Public title
Investigating the effect of mindfulness based cognitive therapy on sexual satisfaction and distress of married women with cyclic mastalgia
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having breast pain for more than 5 days per month according to the Cardiff breast pain table and pain intensity greater than 4 in every 5 days according to the objective pain ruler .
Married women
Age range of 20 years to before menopause
Having regular menstrual periods
Willingness to participate in the study
Exclusion criteria:
Having marital conflicts based on the person's statement
Pregnancy
Breastfeeding
Suffering from physical and mental illnesses (self-reported)
Personal or family history of breast cancer
receiving medical treatment to reduce breast pain in the last three months
Using hormonal methods to prevent pregnancy
History of surgery or breast sampling
Age
From 20 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
For random allocation, four block method will be used. In order to determine the sequence of allocation by the four block method, random allocation sequence generation software will be used. The quadruple block method is used to avoid significant imbalances in the number of participants assigned to each group. Block randomization ensures that there is no significant imbalance between groups at any time during randomization and that at any given point the number of participants in each group is equal. By using the balanced block randomization method (block randomization balanced) with blocks of four, they will be placed in two test and control groups. By choosing 18 quadruple blocks, people will be randomly assigned to test and control groups.
Hiding the allocation sequence: In order to hide the allocation sequence, the papers specifying the group of people will be placed in white envelopes and coded in the same order. Then, a questionnaire with the same code will be completed for the person who will be in the intervention 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
Ethics committee of Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Approval date
2024-08-07, 1403/05/17
Ethics committee reference number
IR.QUMS.REC.1403.190
Health conditions studied
1
Description of health condition studied
Cyclic mastalgia
ICD-10 code
N64.4
ICD-10 code description
Mastodynia
2
Description of health condition studied
sexual satisfaction
ICD-10 code
ICD-10 code description
3
Description of health condition studied
sexual distress
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sexual satisfaction score in the Sexual Satisfaction Scale for Women
Timepoint
Measurement of sexual satisfaction at the beginning of the study (before the intervention) and in the follow-ups one and three months after the intervention
Method of measurement
The Sexual Satisfaction Scale for Women
2
Description
Sexual distress score in the Sexual Satisfaction Scale for Women
Timepoint
Measurement of sexual distress at the beginning of the study (before the intervention) and in the follow-ups one and three months after the intervention
Method of measurement
The Sexual Satisfaction Scale for Women
3
Description
Mindfulness score in The Five Facet Mindfulness Questionnaire
Timepoint
Measurement of mindfulness at the beginning of the study (before the intervention) and in the follow-ups one and three months after the intervention
Method of measurement
The Five Facet Mindfulness Questionnaire
Secondary outcomes
1
Description
The intensity of breast pain according to the score of Visual analog scale
Timepoint
At the beginning of the study (before the start of the intervention) and in the follow-ups 1 and 3 months after the intervention
Method of measurement
Visual analog scale
Intervention groups
1
Description
Intervention group: Cognitive therapy based on mindfulness will be planned in the form of eight approximately two-hour sessions and will be held virtually twice a week.How to present the intervention: The first session of this consultation will be in person at the comprehensive health centers of Qazvin city to introduce and explain the objectives of the study as well as explanations about periodic breast pain. Other meetings will be held individually through virtual networks (ITA, Telegram, WhatsApp) that are available to the participants. For this purpose, the time of each of the online meetings will be determined in advance based on the convenience of the participant. On the designated date, the participant and the researcher will be online at the same time. The researcher will first present the desired content to the participant in each session, and the possibility of interaction between the participant and the researcher will be provided for question and answer and to ensure the correct understanding of the presented content. These meetings will be online, which leads to two-way communication between the consultant and the participant, and people can easily talk about their problems and get the answers they need from the consultant. Educational content will be provided to the participants in the form of audio and text files along with online counseling.
Category
Treatment - Other
2
Description
Control group: The control group will also receive routine care and no intervention will be done for them. At the end of the study, the prepared files will be provided to them, and if necessary, a counseling session will be held for them.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive health centers of Qazvin city
Full name of responsible person
Elnaz Abedi
Street address
Qazvin, University Street, located in the center of Shahid Blandian
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3365 2972
Email
elnazabedi13780@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyed Mahdi Mirhashemi
Street address
Qazvin, Shahid Bahonar Boulevard, Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
sm.mirhashemi@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
1
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
Qazvin University of Medical Sciences
Full name of responsible person
Elnaz Abedi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3366 1768
Email
elnazabedi13780@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Elnaz Abedi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3366 1768
Email
elnazabedi13780@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Elnaz Abedi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3366 1768
Email
elnazabedi13780@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
Yes - There is a plan to make this available
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
Only part of the data is shared
When the data will become available and for how long
5 months
To whom data/document is available
researchers
Under which criteria data/document could be used
Research design
From where data/document is obtainable
Elnaz Abedi, elnazabedi13780@gmail.com, postal code: 3419759811
What processes are involved for a request to access data/document