Assessment the effect of the health promoting lifestyle education in multimedia method on the sexual function and marital satisfaction of womens with Multiple Sclerosis
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 "in available" .
The researcher invites women members of the MS association (MSA) to participate in the study by placing a notice on the walls of the association.
After referring the candidates to the corresponding person present on MSA to give the general and complete explanations, 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 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
Acronym
IRCT registration information
IRCT registration number:IRCT20200203046355N1
Registration date:2020-07-25, 1399/05/04
Registration timing:prospective
Last update:2020-07-25, 1399/05/04
Update count:1
Registration date
2020-07-25, 1399/05/04
Registrant information
Name
Azadeh Ahadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2293 0168
Email address
ahadi1347@gmail.com
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 randomly divided into intervention and control groups by simple random allocation and sampling continued until the samples size reached 44 persons 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.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences