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Effect of Mizaj- Based education on Couples sexual satisfaction

Protocol summary

Summary
The aim of this study is to determine the effect of performing mizaj-based education on couples’ sexual satisfaction. This is a Randomized Controlled Trial study. 30 couples attending to healthcare centers of Sari city, with reproductive age, at least one year get married, live with their spouse and have sexual dissatisfaction, if they wish to participate in the study, they are randomly divided into control (15 couples) and intervention groups (15 couples). The samples will not be deleted but it will be done by intention-to-treat method. Sessions will be held in groups. The study questionnaire include of demographic information, GHQ, Larson , check table the positive and negative stimuli identification impact on sexual satisfaction. At baseline, participant in both groups will complete questionnaires. Then couples in intervention group participate in 4 training 120 minute sessions once a week. The assessment of sexual satisfaction in two groups will be conducted during the zero stage and 4 weeks and 3 months after starting the study. The person assessing the outcome, about the group that belongs the participant in it, is blind. In order to ethical considerations, at the end of sampling, a session of health education will be held and the educational booklet will be presented to the couples in control group.

General information

Acronym
Effect of Mizaj- Based education on sexual satisfaction
IRCT registration information
IRCT registration number: IRCT2017041631117N2
Registration date: 2017-10-26, 1396/08/04
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-10-26, 1396/08/04
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
Vice-chancellor for research, Mazandaran University of Medical Sciences, Sari, Iran
Expected recruitment start date
2017-10-12, 1396/07/20
Expected recruitment end date
2018-04-20, 1397/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Mizaj- Based education on Couples sexual satisfaction
Public title
Effect of Mizaj- Based education on Couples sexual satisfaction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Couple in their reproductive age; whom be married at least for one year; one or both of them have sexual dissatisfaction; don't have physical or mental diseases according to GHQ questionnaire. Exclusion criteria: Mental and physical disorders such as diabetes; thyroid; hypertension and heart diseases which cause sexual disorder; taking medications which make sexual disorder; receiving treat for sexual disorder (medication or behavior).
Age
From 15 years old to 49 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
nothing

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
vice chancellor for research of Mazandaran University of Medical Sciences, Moalem Square.
City
Sari
Postal code
Approval date
2017-03-05, 1395/12/15
Ethics committee reference number
IR.MAZUMS.REC.95. 2854

Health conditions studied

1

Description of health condition studied
sexual unsatisfaction
ICD-10 code
F52, F52.1
ICD-10 code description
Sexual dysfunction, not caused by organic disorder or disease

Primary outcomes

1

Description
sexual unsatisfaction
Timepoint
0, 4weeks and 3 months after intervention
Method of measurement
Larson's sexual satisfaction (LSS) questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Four educational–consultative sessions will be held in couples once a week. The contents of the sessions include, training in the field of mizaj and correction of general behaviors including sleep and wake, nutrition, mental status, stress and discharge of body`s wasted.
Category
Lifestyle

2

Description
Control group: Individual health education provided to the control group during the study period. for ethical considerations, a mizaj education booklet will give to this group.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
4 healthcare centers, Sari city
Full name of responsible person
Dr Soghra Khani
Street address
sexual and reproductive health research center, Vesal street, Amir Mazandarani Boulvard
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chansellor for research Mazandaran University of Medical Sciences
Full name of responsible person
Dr Enayati
Street address
vice chansellor for research of Mazandaran University of Medical Sciences, Moalem squre
City
Sari
Grant name
Grant code / Reference number
95-2854
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chansellor for research Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences, Sexual and Reproductive Health Research Center
Full name of responsible person
Dr Soghra Khani
Position
PhD, Moderator (owner) of project
Other areas of specialty/work
Street address
sexual and reproductive healthresearch center, Vesal street, Amir Mazandarani Boulevard
City
Sari
Postal code
Phone
+98 11 3335 8918
Fax
Email
s.khani@mazums.ac.ir, khanisog343@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr soghra Khani
Position
Modarator (owner) of [project/ PhD]
Other areas of specialty/work
Street address
sexual and reproductive healthresearch center, Vesal street, Amir Mazandarani Boulevard
City
Sari
Postal code
Phone
+98 11 3336 8918
Fax
Email
s.khani@mazums.ac.ir, khanisog343@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Soghra Khani
Position
PhD/moderator (owner) of project
Other areas of specialty/work
Street address
sexual and reproductive healthresearch center, Vesal street, Amir Mazandarani Boulevard
City
Sari
Postal code
Phone
+98 11 3335 8918
Fax
Email
s.khani@mazums.ac.ir, khanisog343@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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