Evaluating the effect of psychosexual counselling based on the PLLISIT model on sexual satisfaction in women with periodic mastalgia
Design
In this clinical trial, subjects are randomly assigned to one of two groups: the experimental group receiving the intervention, and the control receiving the conventional treatment. The sample size is considered to be 90 (45 patients in each group). To evaluate the efficacy of the study, questionnaires will be completed by all patients before and after the intervention.
Settings and conduct
In this study, subjects are randomly selected from one "Comprehensive Urban Health Center" from each four different regions of Qazvin City; Northwest, Northeast, Southwest and Southeast plus a "Breast Hospital Clinic".
Participants/Inclusion and exclusion criteria
inclusion criteria:
cyclic breast pain
Minimum age of 20 years old
regular menstrual periods
Married
Exclusion criteria:
pregnancy
menopause
Lactation
physical or mental illness
breast cancer
Medical treatment
hormonal methods for contraception
Intervention groups
The intervention will be individual counselling based on the PLISSIT model. Consultation for the intervention group will be carried out in at least four sessions. Sessions take place on a weekly basis and each lasts for 90 minutes. The control group will receive routine care.
Main outcome variables
Sexual satisfaction, sexual distress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180826040862N1
Registration date:2019-01-07, 1397/10/17
Registration timing:registered_while_recruiting
Last update:2019-01-07, 1397/10/17
Update count:0
Registration date
2019-01-07, 1397/10/17
Registrant information
Name
Fatemeh Ghodsi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3293 5402
Email address
f.ghodsi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Sexual Satisfaction after Psychosexual Counselling in Women with Cyclic Mastalgia: An Intervention Study based on the PLISSIT Model
Public title
The Effect of Sex Counseling on Sexual Satisfaction in Women with Cyclic breast pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Breast pain of four or above based on the visual analogue scale pain which lasts more than five days according to the Cardiff Breast Clinic.
At least 20 years old
Having regular menstrual periods
Being Married and having regular sex
No menopause
Exclusion criteria:
pregnancy
Lactation
Having physical or mental illness (self-declaration)
Family or personal history of breast cancer
Drug Administration for treating breast pain in the last three months
Using hormonal methods for contraception
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:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The assignment of women with cyclic mastalgia into groups of intervention and control follows the method of simple randomization. According to this method, in each treatment center, a pool with letters of either A or B kept within sealed envelopes will be considered. The number of envelopes matches the number of subjects in the study. Envelopes will be drawn from the pool without replacement by each subject who enters the study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
This study consists of two groups witch one group receiving the intervention.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of qazvin University of Medical Sciences
Street address
Shahid Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Approval date
2018-09-25, 1397/07/03
Ethics committee reference number
IR.QUMS.REC.1397.138
Health conditions studied
1
Description of health condition studied
Cyclic Mastalgia, Sexual Satisfaction
ICD-10 code
N64.4
ICD-10 code description
Mastodynia
Primary outcomes
1
Description
Sexual satisfaction
Timepoint
Before the intervention - one month after the intervention - three months after the intervention
Method of measurement
Larson Sexual Satisfaction Questionnaire
Secondary outcomes
1
Description
Sex Distress
Timepoint
Before the intervention- one month after the intervention - three months after the intervention
Method of measurement
Sexual Distress Dissolved Questionnaire
Intervention groups
1
Description
Intervention group: First, questionnaires will be completed by patients. This then will be followed by four one to one in-person counselling sessions. Sessions take place on a weekly basis and each lasts for 90 minutes. According to the PLISSIT model, sessions are summarised as follows: Session 1: Patient administration. During this session, the history of breast pain and sexual discomforts of the patient will be recorded.Session 2: Patient will receive a brief anatomical and physiological summary of limbs and breast.Session 3: Explicit recommendations. At this session, consultation on specific concerns such as fundamental sexual related concepts and training on specific sexual attitudes and practices and various forms of sexual stimulation will be provided. Mental health screening will also be conducted at this session.Session 4: Referral for comprehensive treatment: After a careful evaluation of the patient's performance during the previous meetings, the patient will be referred if it was concluded that she requires more specialist psychosexual counselling in areas such as male sexual dysfunctions and psychological disorders.Patients will be asked to fill the questionnaires after the intervention completion and also three months after the final counselling session.
Category
Rehabilitation
2
Description
Control group: First, patients are asked to complete the questionnaire. Patients in this group will receive the current standard treatment for Mastalgia. The investigator will not provide the routine treatment. After completing counselling sessions for the intervention group, the control group will be asked to complete the questionnaire simultaneously.If the PLISSIT method outperforms the current standard treatment, after finishing the study, for ethical considerations, patients in the control group will also be introduced to the psychosexual counselling sessions by the investigator.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Educational and therapeutic center of the Velayat
Full name of responsible person
Fatemeh Ghodsi
Street address
22 bahman
City
Qazvin
Province
Qazvin
Postal code
3471976161
Phone
+98 28 3379 0620
Email
hosvelayat.qums@yahoo.com
2
Recruitment center
Name of recruitment center
Health Center No. 5 (Valiasr)
Full name of responsible person
Fatemeh Ghodsi
Street address
Shahid beheshti
City
Qazvin
Province
Qazvin
Postal code
3415633956
Phone
+98 28 3334 5057
Email
infobhc@qums.ac.ir
3
Recruitment center
Name of recruitment center
Health Center No. 12 (Taghavi)
Full name of responsible person
Fatemeh Ghodsi
Street address
Dehkhoda Square. Minoder area.
City
Qazvin
Province
Qazvin
Postal code
3471749839
Phone
+98 28 3378 3300
Email
infobhc@qums.ac.ir
4
Recruitment center
Name of recruitment center
Health Center No. 11 (Shahid bolandian)
Full name of responsible person
Fatemeh Ghodsi
Street address
End of University Street
City
Qazvin
Province
Qazvin
Postal code
3414763111
Phone
+98 28 3365 2972
Email
infobhc@qums.ac.ir
5
Recruitment center
Name of recruitment center
Health Center No.2 (shohada)
Full name of responsible person
Fatemeh Ghodsi
Street address
Shohada street
City
Qazvin
Province
Qazvin
Postal code
3418737531
Phone
+98 28 3355 2933
Email
infobhc@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
fatemeh ghodsi
Street address
Bahonar
City
Qazvin
Province
Qazvin
Postal code
1531534199
Phone
+98 28 3333 6001
Email
info@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
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
All data from questionnaires is able to be shared (without the names of the samples).
When the data will become available and for how long
Six months after the publication of the results in the official journals
To whom data/document is available
All researchers working in educational and industrial institutions can apply for it.
Under which criteria data/document could be used
If our documentation prevents repetition of a similar study.
If our documentation makes progress in a research process.
From where data/document is obtainable
The main implementer of the project: Fatemeh Ghodsi
Address: unit 27, Ofogh 8 Building, 10th alley, Ferdowsi Avenue, Sadoghi Avenue
Tell:00989338678004
email: F.ghodsi@qums.ac.ir , fatimaghodsi@gmail.com
What processes are involved for a request to access data/document
It is necessary for the applicant to provide a complete introduction of his or her identity and to explain clearly why his request is necessary. After consultation with other administrators, in particular the supervisor, the requested files will be sent.