Determining the effect of virtual stress management training on sexual performance of women around menopause
Design
Quasi-experimental study of a group before and after
Settings and conduct
this study is a quasi-experimental study that on 50 women aged 40 to 50 years referred to Sohrab Ali Bakhshi Health Center under the auspices of Iran University of Medical Sciences located in the Shahriar city of Tehran will be done. After obtaining permission from the ethics committee of Iran University of Medical Sciences and referring to the research environment among the qualified women who refer to the above center who after providing the necessary explanations about the objectives and how to conduct research, want to participate in the study. , Informed consent will be received Sampling will be done continuously for 12 weeks (3 months), with reference to electronic household records and sampling in 5 groups of 10 people. The samples will first complete the demographic and sexual function questionnaires. Questionnaires will be completed virtually and . Stress management training will be held in the form of 8 30-minute virtual sessions, twice a week for 4 weeks, using the WhatsApp social network. Sexual function will be determined before, 4 and 8 weeks after the intervention.
Participants/Inclusion and exclusion criteria
1.Have a minimum literacy؛ Current pregnancy and lactation and one year before the start of the study
2.Having a cell phone and smartphone line or computer or laptop or iPad during the intervention؛ Occurrence of stressful experiences during the last 3 months for couples
Intervention groups
Intervention groups include women around menopause with the age of 40 to 50 years referred to Sohrab Ali Bakhshi Comprehensive Health Center in Shahriar city. After filling in the informed consent form by the samples, sampling will be done continuously. Stress management training will be in the form of 8 virtual 30-minute sessions.
Main outcome variables
Sexual function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140823018903N2
Registration date:2021-11-17, 1400/08/26
Registration timing:registered_while_recruiting
Last update:2021-11-17, 1400/08/26
Update count:0
Registration date
2021-11-17, 1400/08/26
Registrant information
Name
Leila Neisani Samani
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 2846
Email address
nneysani@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of virtual training stress management education on sexual function of women around menopause
Public title
Studying the effect of virtual training stress management education on sexual function of women around menopause
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Have a minimum literacy
Having a cell phone and smartphone line or computer or laptop or iPad during the intervention
Living with spouse for the past 6 months
Failure to receive hormone therapy or complementary medicine related to fertility and menopause for the past 6 months
No known mental health problems or systemic illnesses (such as diabetes, hypertension, kidney disease)
Having sex with spouse during the study and one month before
Monogamy
The couple's first marriage
Have at least one period in the last 3 months
Exclusion criteria:
Current pregnancy and lactation and one year before the start of the study
Occurrence of stressful experiences during the last 3 months for couples
Alcohol use or drug abuse in couples (while studying and in the history of couples)
Age
From 40 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of iran university of medical sciences
Street address
Hemmat Highway between Chamran and Sheikh Fazlollah Iran University of Medical Sciences Headquarters Fifth Floor
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-10-03, 1400/07/11
Ethics committee reference number
IR.IUMS.REC.1400.620
Health conditions studied
1
Description of health condition studied
Stress management training on sexual function
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sexual function score of women around menopause using Rosen et al.'s sexual function questionnaire
Timepoint
Determining the score of sexual function at the beginning of the study (before the intervention), 4 and 8 weeks after the intervention.
Method of measurement
Rosen et al. Female sexual function index questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Implementing a virtual training program for stress management for 5 groups of 10 women around menopause in 8 sessions of 30 minutes 2 times a week for 4 weeks using WhatsApp social network.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Sohrab Ali Bakhshi Shahriar Comprehensive Health Center
Full name of responsible person
Dr Afsaneh Bagheri
Street address
Tehran Province, Shahriar, Enghelab St., next to Imamzadeh Ismail, not far from Ansar Alley, Sohrab Ali Bakhshi Health Center
City
Shahriyar
Province
Tehran
Postal code
3351738998
Phone
+98 21 6522 2911
Fax
+98 21 6522 6832
Email
Shahriar@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. hossein Keyvani
Street address
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences, fifth floor of the headquarters
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Fax
+98 21 8862 2703
Email
Research_m@iums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Leila neysani samani
Position
Faculty of medical sciences
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Tehran School of Nursing and Midwifery, Rashid Yasemi St., above Vanak Square, Vali Asr St., Tehran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 6543 1000
Fax
+98 21 8820 1978
Email
neisani89@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila neysanisamani
Position
Faculty of medical sciences
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Iran School of Nursing and Midwifery, Rashid Yasemi St., above Vanak Square, Valiasr St., Tehran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Fax
+98 21 8820 1978
Email
Neisani89@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Neisani Samani
Position
Faculty of medical sciences
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Iran School of Nursing and Midwifery, Rashid Yasemi St., above Vanak Square, Valiasr St., Tehran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Fax
+98 21 8820 1978
Email
neisani89@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Failure to disclose information in order to maintain confidentiality
When the data will become available and for how long
Failure to disclose information in order to maintain confidentiality
To whom data/document is available
Failure to disclose information in order to maintain confidentiality
Under which criteria data/document could be used
Failure to disclose information in order to maintain confidentiality
From where data/document is obtainable
Failure to disclose information in order to maintain confidentiality
What processes are involved for a request to access data/document
Failure to disclose information in order to maintain confidentiality
Comments
In the clinical study report section, according to the university guide, the report will be presented to the research system.