Protocol summary
-
Study aim
-
Assessment the effect of the health promoting lifestyle education in multimedia method on the sexual function and marital satisfaction of womens with Multiple Sclerosis
-
Design
-
A clinical trial, control and intervention groups, simple randomization, 58 person per group
-
Settings and conduct
-
The field of research is sexual function and marital satisfaction of women with MS and the study site is MS Association in Tehran.
After obtaining the necessary permits, sampling will be done with the method of "continuous" .
The researcher invites women to participate in the study by placing a notice on the walls of Hazrat Rasool Hospital and Private Neurology Clinic and
telephone calls to previous hospital patients based on file access.
After give the complete explanations to
volunteers, the eligible ones will be selected according to the inclusion criteria.
The participants will be randomly assigned to the intervention (IG) and control (CG) groups by simple random
Based on the 4,6,8 blocking formula of Sealed Envelope Ltd.2020 . After completing written-consent by both groups and to prevent data leakage, CG will first complete the demographic form and questionnaires, and again will complete the questionnaires after 4 and 12 weeks from the beginning.
IG will complete these forms and receive the electronic content of education (ECE) in 4 session. Questionnaires will be completed electronically by IG at weeks 4 and 12. The educational topics health promotion life style for IG will be presented in 4 sessions.
Finally, a CD including ECE will be sent to CG.
-
Participants/Inclusion and exclusion criteria
-
Married women with MS, if they do not decide to divorce and do not participate in similar programs simultaneously
-
Intervention groups
-
Intervention group receive multimedia education and control group receive no intervention
-
Main outcome variables
-
Health promoting lifestyle education
General information
-
Reason for update
-
change location and sampling method
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20200203046355N1
Registration date:
2020-07-25, 1399/05/04
Registration timing:
prospective
Last update:
2021-02-12, 1399/11/24
Update count:
1
-
Registration date
-
2020-07-25, 1399/05/04
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2020-09-05, 1399/06/15
-
Expected recruitment end date
-
2021-03-05, 1399/12/15
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Assessment the effect of the health promoting lifestyle education in multimedia method on the sexual function and marital satisfaction of womens with Multiple Sclerosis
-
Public title
-
Assessment the effect of the health lifestyle education on the sexual function of womens with MS
-
Purpose
-
Education/Guidance
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Married Iranian women aged 20-45 years
more than six months' history of MS
ability to use smartphones
married more than one year ago
having sex at least once in the past month
ability to perform daily personal affairs
Exclusion criteria:
The decision to divorce
Pregnancy
Menopause
Concurrent with another chronic illness
Use of sleeping drugs and alcohol and drugs
Facing severe crises, including the death of loved ones over the past six months
Participate in similar programs to enhance marital satisfaction and sexual function
-
Age
-
From 20 years old to 45 years old
-
Gender
-
Female
-
Phase
-
N/A
-
Groups that have been masked
-
No information
-
Sample size
-
Target sample size:
116
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Participants were simply randomized (by simple random allocation) and blocked (using Sealand Envelope website, simple randomizer list-maker) divided into blocks of 4, 6 and 8 people in 2 groups of intervention and control.
Also sampling continues until the samples size reached 58 people in each group.
-
Blinding (investigator's opinion)
-
Not blinded
-
Blinding description
-
-
Placebo
-
Not used
-
Assignment
-
Other
-
Other design features
-
After dividing the samples by simple random allocation to the intervention and control groups, the intervention group will receive the necessary training. Then sexual function and marital satisfaction will be compared at the end of the intervention and follow-up period.
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2020-07-14, 1399/04/24
-
Ethics committee reference number
-
IR.IUMS.REC.1399.367
Health conditions studied
1
-
Description of health condition studied
-
Multiple Sclerosis
-
ICD-10 code
-
G35
-
ICD-10 code description
-
Multiple sclerosis
Primary outcomes
1
-
Description
-
Sexual Function and Marital Satisfaction Score
-
Timepoint
-
Baseline, 4 and 12 weeks after baseline
-
Method of measurement
-
Questionnaire before and after training and follow-up
Intervention groups
1
-
Description
-
Intervention group:Intervention group - health promoting lifestyle education in a multimedia way, with nutrition components, health responsibility, exercise, self-fulfillment, interpersonal relationships, stress management, in four 40-minute sessions
-
Category
-
Other
1
-
Sponsor
-
-
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
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
-
Sexual function, Marital satisfaction
-
When the data will become available and for how long
-
After2021
-
To whom data/document is available
-
Researchers, midwives, doctors, and patients with MS
-
Under which criteria data/document could be used
-
Scientific promotion of researchers and improvement of sexual function and marital satisfaction of women with MS
-
From where data/document is obtainable
-
Google scholar
-
What processes are involved for a request to access data/document
-
Login to Google Scholar and download articles after searching for a keyword
-
Comments
-