Comparing the effectiveness of solution focused counseling with routine care on sexual function of women with hypothyroidism
Design
A randomized controlled clinical trial with two parallel intervention and control arms
Settings and conduct
Referring to two sub-specialized endocrinology clinics of Mazandaran University of Medical Sciences, identifying eligible people, dividing patients into two intervention and control groups randomly, completing questionnaires by both groups, determining the appropriate place to hold consultation sessions (Tooba and Mostavafian Clinics). The evaluation of the results will be done using the PORSLINE through the social networks Eitaa or WhatsApp (according to the individual's choice).
Participants/Inclusion and exclusion criteria
Married women who have been married for at least one year / At least elementary education / Age range 18 to 49 years / Having a smartphone / At least one year of hypothyroidism diagnosed by an endocrinologist / Sexual function score 26.5 or less based on the scale FSFI/ score above 11 on the FSDS-R scale/Pregnancy and breastfeeding/menopause/history of infertility/history of pelvic surgery/sexual dysfunction in spouse (male)/smoking, alcohol and hookah/suffering from physical diseases affecting sexual function/use of drugs affecting sexual function/suffering to mental illnesses (score 23 and above based on the GHQ questionnaire)/participating in educational and counseling courses related to improving sexual function during the last 6 months
Intervention groups
Intervention group: individual counseling sessions will be conducted in 5 sessions of 45 minutes at an interval of one week.
Control group: After completing the study, they will be provided with a pamphlet containing educational materials during a session
Main outcome variables
Sexual function in women with hypothyroidism
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161126031117N16
Registration date:2024-10-19, 1403/07/28
Registration timing:prospective
Last update:2024-10-19, 1403/07/28
Update count:0
Registration date
2024-10-19, 1403/07/28
Registrant information
Name
Soghra Khani
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 8918
Email address
s.khani@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-22, 1403/08/01
Expected recruitment end date
2025-01-19, 1403/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of solution focused counseling with routine care on the sexual function of women with hypothyroidism
Public title
The effectiveness of solution focused counseling on the sexual function of women with hypothyroidism
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Married women who have been married for at least one year
At least elementary education
Age range 18 to 49 years
Having a smartphone
At least one year of hypothyroidism diagnosed by an endocrinologist
Sexual function score 26.5 or less based on the scale FSFI
score above 11 on the FSDS-R scale
Exclusion criteria:
Pregnancy and breastfeeding
menopause
history of infertility
history of pelvic surgery
sexual dysfunction in spouse (male)
smoking, alcohol and hookah
suffering from physical diseases affecting sexual function
use of drugs affecting sexual function
suffering to mental illnesses (score 23 and above based on the GHQ questionnaire)
participating in educational and counseling courses related to improving sexual function during the last 6 months
Age
From 18 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the samples are matched based on the duration of hypothyroidism and the block method will be used for random allocation of the samples. For this purpose, two blocks will be considered. Two possible blocks are TC and CT, where T is for the intervention group and C is for the control group. The numbers will be generated randomly (with the RANDBETWEEN command in Excel software and in the range 1 and 2) and according to the production values of one of the blocks (for a production number 1 CT block, for a production number 2 TC blocks) and the samples will be allocated Found.
Blinding (investigator's opinion)
Single blinded
Blinding description
The evaluation of the consequences will be done using the PORSLINE through the social networks Eitaa or WhatsApp (according to the individual's choice). The researcher and the evaluator do not know the group to which the participant belongs when evaluating the outcome.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Moalem Square, Moalem Street
City
Sari
Province
Mazandaran
Postal code
4816715793
Approval date
2024-08-13, 1403/05/23
Ethics committee reference number
IR.MAZUMS.REC.1403.252
Health conditions studied
1
Description of health condition studied
Hypothyroidism
ICD-10 code
E03.9
ICD-10 code description
Hypothyroidism, unspecified
Primary outcomes
1
Description
Sexual function in women with hypothyroidism
Timepoint
Determining the sexual function of hypothyroid women before, after and four weeks after the intervention
Method of measurement
Female Sexual Function Index (FSFI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: after completing the pre-test, individual counseling sessions will be conducted for 45 minutes and during 5 sessions with an interval of one week. People will be contacted once or twice a week to ensure that they complete their assignments. Immediately after the completion of the intervention sessions, the post-test and the session for follow-up and re-evaluation of the two groups in terms of sexual function (evaluation of the effectiveness of the treatment, people's satisfaction with the results, handling of new or ongoing concerns) will be four weeks later.
Category
Behavior
2
Description
Control group: after completing the study, a pamphlet containing educational materials about hypothyroidism and its effect on sexual function and solutions to improve it will be provided to them.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology Clinic of Mazandaran University of Medical Sciences (Baghban (Tooba) and Mostafavian)
Full name of responsible person
Dr. Soghra Khani
Street address
Vasal St, Amir Mazandarani Blvd
City
sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 8918
Fax
+98 11 3336 8915
Email
khanisog343@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Ahmad Ali Enayati
Street address
Moalem square, Moalem street
City
Sari
Province
Mazandaran
Postal code
4816717887
Phone
+98 11 3339 8303
Fax
+98 11 3339 8303
Email
enayati@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Nastaran Salehi Tilaki
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Khazar Square
City
Sari
Province
Mazandaran
Postal code
4818151851
Phone
+98 11 3368 9182
Email
nastaran.salehi07@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Soghra Khani
Position
PhD/ Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Vasal St, Amir Mazandarani Blvd
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 8918
Fax
+98 11 3336 8915
Email
khanisog343@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Nastaran Salehi Tilaki
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Khazar Square
City
Sari
Province
Mazandaran
Postal code
4818151851
Phone
+98 11 3368 9182
Email
nastaran.salehi07@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
The information related to the research is shared with the aim of keeping the names of the people and keeping their identities confidential and complying with the 31 code of ethics.
When the data will become available and for how long
Since 1404
To whom data/document is available
All researchers and those interested in research
Under which criteria data/document could be used
To conduct review and supplementary research and for the use of hypothyroidism therapists
From where data/document is obtainable
In order to receive documents or data, the corresponding author can be reached by email at khanisog343@gmail.com and counseling student in midwifery at nastaran.salehi07@gmail.com. If the article is published according to the journal address, you can refer to that journal.
What processes are involved for a request to access data/document
First, you should send an email to the responsible author of the article and make your request, and if the responsible author and the research team deem it appropriate, the documents and files will be provided in a short period of time.