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Comparison the efficacy of reality therapy in group counselling and life skills training on quality of life of menopausal women

Protocol summary

Summary
This study aimed to evaluate the effectiveness of life skills training and counseling reality therapy on quality of life in menopausal women in Arak.This research is educational trial.Research done in the city in 1393.The sample size in each group is 20 people.Sampling at five clinics in the five districts of the city and Retirement center cityand Charitable seniors Easy and simple to be done. Inclusion criteria:48-55 years, 12 months have passed since their last menstrual period ,Persian origin, primary education is the minimum level of education,don't training courses already have passed the menopause before education, lack of drug addiction, lack of chronic illness, ,lack of getting the treatment of hormone therapy to treat symptoms of menopause, Interested in participating in the study,Lack of mental health problems exclusion criteria:An unwillingness to continue participation in the study. Absenteeism over a meeting,The incidence of adverse events and circumstances prior to collecting data on the second questionnaire . The participants are selected based on criteria. If there is a requirement for inclusion demographic and quality of life questionnaire(MENQOL) is completed. The women are divided into three groups A, B and C. group of A of women training skills training will be given.group of B of women will teach counselling choice theory.group of C are controls . After one month of the end teaching and counseling Quality of Life Questionnaire (MENQOL) again completed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014120920258N2
Registration date: 2015-03-26, 1394/01/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-03-26, 1394/01/06
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences and Health Services
Expected recruitment start date
2014-12-20, 1393/09/29
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the efficacy of reality therapy in group counselling and life skills training on quality of life of menopausal women
Public title
Comparison the efficacy of reality therapy in group counselling and life skills training on quality of life of menopausal women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:48-55 years, 12 months have passed since their last menstrual period ,Persian origin, primary education is the minimum level of education,don't training courses already have passed the menopause before education, lack of drug addiction, lack of chronic illness, ,lack of getting the treatment of hormone therapy to treat symptoms of menopause, Interested in participating in the study,Lack of mental health problems exclusion criteria:An unwillingness to continue participation in the study. Absenteeism over a meeting,The incidence of adverse events and circumstances prior to collecting data on the second questionnaire
Age
From 48 years old to 55 years old
Gender
Female
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)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Arak University of Medical Sciences and Health Services
Street address
Counseling in midwifery group, School of Nursing and Midwifery, Arak University of Medical Sciences,payambar azam, sardasht, Basij, Arak, Iran
City
Arak
Postal code
38481-7-6941
Approval date
2014-12-01, 1393/09/10
Ethics committee reference number
93-24-171

Health conditions studied

1

Description of health condition studied
Menopause counseling- quality of life
ICD-10 code
Z71.9
ICD-10 code description
Counselling, unspecified

Primary outcomes

1

Description
Quality of life after reality counseling
Timepoint
Before intervention-one month after intervention
Method of measurement
Questionnaire of quality of life menopausal women(MENQOL)

2

Description
Quality of life after training life skills
Timepoint
before intervention-one month after intervention
Method of measurement
Questionnaire of quality of life menopausal women(MENQOL)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention groups: There are two groups. One group menopause women train life skills in 8 sessions for two hours, Researcher see this women in three days a week. Control measures might not accept them.
Category
Lifestyle

2

Description
Intervention Group: The next group menopause women counseling reality therapy in 8 sessions for two hours, Researcher see this women in three days a week. Control measures might not accept them.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Five clinics in Arak city
Full name of responsible person
Fariba-Farokhi-student of master of counseling in midwifery
Street address
City
Arak

2

Recruitment center
Name of recruitment center
Institutions of Charitable Elderly
Full name of responsible person
Fariba-Farokhi-student of master of counseling in midwifery
Street address
City
Arak

3

Recruitment center
Name of recruitment center
Center for Retirement
Full name of responsible person
Fariba-Farokhi-student of master of counseling in midwifery
Street address
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences and Health Services
Full name of responsible person
Fereshte Narenji, Faculty
Street address
Arak medical science university, Payambar azam Educational Complex, Meidan Basij, Sardasht
City
Arak
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 and Health Services
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
Arak University of Medical Sciences and Health Services
Full name of responsible person
Fariba Farokhi
Position
Student of master of counseling in midwifery
Other areas of specialty/work
Street address
MSc student in midwifery in counseling, School of Nursing and Midwifery, Arak University of Medical Sciences-Payambar azam Educational Complex, Basij, Sardasht
City
Arak
Postal code
38481-7-6941
Phone
+98 86 3471 3505
Fax
Email
f.farokhi@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences and Health Services
Full name of responsible person
Fereshte Narenji
Position
Faculty
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Arak University of Medical Sciences, Payambar azam Educational Complex, Basij, Sardash
City
Arak
Postal code
38481-7-6941
Phone
+98 86 3417 3505
Fax
Email
fnarenedjie@yahoo.ca
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences and Health Services
Full name of responsible person
Fariba Farokhi
Position
Student of master of counseling in midwifery
Other areas of specialty/work
Street address
MSc student in midwifery in counseling, School of Nursing and Midwifery, Arak University of Medical Sciences-Payambar azam Educational Complex ,Basij ,Sardash ,Arak
City
Arak
Postal code
38481-7-6941
Phone
+98 86 3471 3505
Fax
Email
f.farokhi@arakmu.ac.ir
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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