Protocol summary

Summary
This study was done on 2017 on couples who called clinical centers in SARI aiming on their sexual dissatisfaction. 30 couples who are uplifted for the research divided in 2 groups that recognize with questioner with number of sample's in each group of 15 controlled. The sample will not be deleted but it will be done by INTENTION – TO – TREAT method. After determining the condition and Criterion of entrance, will be present of the control group and after accomplishing the operational stages of the study, a training booklet and 4 training session 120 minute once a week after another adjustment will be present of them in the group form. The final gender assessment will be conducted during the zero stage and 4 weeks and 3 months after starting the study by the consulting professor who is not informed of the group. 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. A week later, the intervention group will be present in training sessions (four 120-minute sessions once a week). 4 weeks later, post-test and fallow-up of the two groups in terms of sexual satisfaction will be done 3 months later. The person assessing the outcome, about the group that belongs the participant in it, is blind. In the control group, during the study will get health intervention, but to consider the ethical aspects, after doing research, training manual containing the contents of the meetings will be presented to them.

General information

Acronym
Effect of Mizaj- Based education on sexual satisfaction
IRCT registration information
IRCT registration number: IRCT2017050531117N3
Registration date: 2017-07-11, 1396/04/20
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-07-11, 1396/04/20
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
Mazandaran University of Medical Sciences
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2018-02-20, 1396/12/01
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 fertility and whom bee married at least for one year who one or both of them have sexual dissatisfaction with less than 100 grade of Larson questionnaire questionnaire: no diagnosis of severe physical or mental disease, according to GHQ questionnaire. Exclusion criteria: mental and physical disorders such as diabetes, thyroid, blood pressures and heard which cause sexual disorder; taking medications which make sexual disorder; beans treat for sexual disorder (medication or behavior) will be asked to referred to expert.
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: 15
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
Vice chansellor for research of Mazandaran University of Medical Sciences, Moalem Sq.
City
Sari
Postal code
Approval date
2017-03-10, 1395/12/20
Ethics committee reference number
IR.MAZUMS.REC.95. 2854

Health conditions studied

1

Description of health condition studied
sexual unsatisfaction
ICD-10 code
F52.1
ICD-10 code description
Sexual aversion and lack of sexual enjoyment

Primary outcomes

1

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

Secondary outcomes

empty

Intervention groups

1

Description
Control group: After determining the physical condition, one session of personal health lesson will be present of the control group and after accomplishing the operational stages of the study, a training booklet and one training session for pc adjustment will be present of them in the group form.
Category
Other

2

Description
Intervention group: sessions will be established to a group couple. Educational – consultative sessions will be established four 120-minute sessions once a week. The contents of the meeting include, training in the field of traditional medicine health center , Determinate of persons physical condition by using the physical condition questioner, physical health training and its different types; Training for adjustment of nutrition condition according of the type of physical condition; Training for adjustment of body movement and sleep and wake condition according of the type of nutrition; Training for adjustment of mental and stress condition and discharge of body`s wasted.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
4 healthcare centers
Full name of responsible person
Street address
City
Sari

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
Vice chansellor for research of Mazandaran University of Medical Sciences, Moalem Sq.
City
Sari
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
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
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 [roject/ 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
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 3336 8918
Fax
Email
s.khani@mazums.ac.irkhanisog343@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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