Protocol summary

Study aim
The Effect of Emotional Intelligence on Sexual Satisfaction in Menopausal Women
Design
Clinical trial with two groups of intervention and control with parallel and, randomized groups, using the random numbers table
Settings and conduct
40 Women referring to the Arak Retirement Center who are eligible to enter the study after obtaining informed consent and score less than 75 in the Larson Sexual Satisfaction Questionnaire and less than 95 in Bar-On Emotional Intelligences are divided into two groups, intervention and control (20 people in each group) with random method and random numbers table. The intervention group received 8 sessions of 90 minutes of emotional intelligence once a week and this is not administered in the intervention group. Each group completed Larson Sexual Satisfaction Inventory and Bar-On Emotional Intelligence Questionnaire one month after the intervention.
Participants/Inclusion and exclusion criteria
Entry requirements: menopausal women, passing at least one year of menopause, speaking in Persian and Iranian nationality, education level higher than diploma, having low sexual satisfaction in Larson Sexual Satisfaction Questionnaire, and low emotional intelligence in the Bar-On Emotional Intelligence Questionnaire. Conditions of non-entry: addiction, occurrence of stressful events in the last 6 months, use of drugs affecting sexual activity, suffering from underlying diseases
Intervention groups
Holding 8 sessions of 90 minutes of group counseling with an emotional intelligence approach in the intervention group and there is no intervention in the control group
Main outcome variables
Increasing the emotional intelligence of menopausal women, increasing the sexual satisfaction of menopausal women

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170616034564N3
Registration date: 2018-07-03, 1397/04/12
Registration timing: registered_while_recruiting

Last update: 2018-07-03, 1397/04/12
Update count: 0
Registration date
2018-07-03, 1397/04/12
Registrant information
Name
nahid ansari
Name of organization / entity
arak univercity of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 46483029
Email address
n.ansari@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Arak University of Medical Sciences
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Group Counseling Based on Emotional Intelligence on the Sexual Satisfaction in Menopausal Women
Public title
The Effect of Group Counseling Based on Emotional Intelligence on the Sexual Satisfaction in Menopausal Women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to speak Persian and Iranian nationality Education level higher than diploma Passing at least one year of menopause Normal menopause
Exclusion criteria:
Drug addiction The occurrence of stressful events in the last 6 months such as: severe illness, Death of a child or first degree relatives, accident, house theft, bankruptcy, job loss, severe marital conflicts with one's own statements Taking effective medicine for sexual performance such as: Anti-epileptic drug, Narcotic drugs, Anti-cellulitis drugs, Anti-histamines, Lipid lowering agents, Progesterone Suffering from underlying diseases such as: Thyroid, Cancer, Diabetes, Hypertension, Pulmonary heart disease, Trauma, Genital surgery, Infectious disease, Depression, Central nervous system damages
Age
From 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
After obtaining a moral authorization and coordination with the relevant organizations from among postmenopausal women who come to Arak retirement center, qualified people who are willing to participate in the study, will be select and informed consent will obtain and the goals of the study will be explained and it will be assured that the information will remain confidential. Then, they will be given personal profile, Emotional Intelligence and Larson Sexual Satisfaction Questionnaires. It will be explain to people that they may be in one of two groups of control or intervention, and the selection of the group will not be with the researcher or sample. At the end of each day, the questionnaires are examined and when 40 eligible people with an emotional intelligence score of less than 90 and a Larson sexual satisfaction score of less than 75 were obtained, sampling was stopped and entered simple, random method by using random numbers tables in one of the 20-persons intervention or control groups. In this way, the even numbers will be assigned to the intervention and odd numbers will be assigned to the control group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Aalam al-Hoda Ave, Shahid Shiroudi Ave, Arak
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR. ARAKMU. REC. 1396. 3136

Health conditions studied

1

Description of health condition studied
Sexual Satisfaction
ICD-10 code
n95.8
ICD-10 code description
Other specified menopausal and perimenopausal disorders

Primary outcomes

1

Description
Sexual Satisfaction
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Larson Sexual Satisfaction Questionnaire

Secondary outcomes

1

Description
Emotional Intelligence
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Bar-on Emotional Intelligence Questionnaire

Intervention groups

1

Description
The intervention group: intervention receives emotional intelligence for 8 sessions for 90 minutes once a week
Category
Behavior

2

Description
Control group: no intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Retirement Center of Arak
Full name of responsible person
Nahid Ansari
Street address
Shahid Najimi Ave, Dr Shariati Ave, Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3402 1481
Email
n.ansari@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mr Doctor Mohammad Rafiee
Street address
Vice chancellor for Research and Technology, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3638
Email
Rsearch@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Nahid Ansari
Position
MSn student in consultation midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Aalam al-Hoda Ave, Shahid Shiroudi Ave, Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 633136055
Fax
Email
n.ansari@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Katayon Vakiliyan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Aalam al Hoda Ave, Shahid Shiroodi Ave, Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3502
Fax
Email
n.ansari@arakmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Nahid Ansari
Position
MSn student in consultation midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Aalam al-Hoda Ave, Shahid Shiroodi Ave, Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Fax
Email
n.ansari@arakmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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