The purpose of this study was to evaluate the effectiveness of Cognitive - Behavioral Group Study conducted on lifestyle of postmenopausal women in Ahwaz. In this clinical trial study, 33 postmenopausal women(17 participant in the intervention group and 16 participant in the control group.) were randomly assigned. Inclusion criteria included Age 45 - 60 years, Natural menopause (absence of menstruation for at least one year ), Women who will aguire score of life style scale in medium or weak Level , Having Educational Level of Primery School and Exclusion criteria included Mental and Physical diseases, Having sad events during the last six months, Addictions to alcohol, drugs and other psycholic drugs. Before intervention ,a Health Promotion Life Style Guestionnare (HPLQ) will be completed by all women in both groups. Participants in both groupswill complete the questionnaires immediately after the intervention and 6 weeks later. The intervention group, 8 sessions of cognitive - behavioral therapy in groups and the control group will receive usual care.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016112631030N2
Registration date:2017-02-15, 1395/11/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-02-15, 1395/11/27
Registrant information
Name
Shiva Yazdizadeh
Name of organization / entity
School Of Nursing And Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 61 3336 2620
Email address
shirinkhorramnia98@gmail.com
Recruitment status
Recruitment complete
Funding source
Jondi Shapour University Of Medical Sciences
Expected recruitment start date
2017-03-04, 1395/12/14
Expected recruitment end date
2017-04-05, 1396/01/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of Group Cognitive-Behavioral Therapy (CBT)On Health Promotion Life Style Of Post Menopausal Women
Public title
The Effect Of Group Cognitive-Behavioral Therapy (CBT)On Health Promotion Life Style Of Post Menopausal Women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : Natural menopause (Absence of Menstruation for at Least One Year );Women Who Will Aguire Score of Lifestyle Scale in Medium (104-155) or Weak (befor 103) Level; Having Educational Level of Primery School;The Appropriateness of Participitent for CBT;Age 45 - 60 Years And Exclusion criteria :Mental and Physical Diseases Based on Self Report;Having Sad Events During The Last Six Months;History of Previous Use of Cognitive- Behavioral Therapy; Addictions to Alcohol, Drugs and Other Psycholic Drugs Based on Self Report؛Use of Antipsychotic Drugs
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
33
Randomization (investigator's opinion)
Randomized
Randomization description
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
Jondi Shapour University Of Medical Sciences
Street address
Jondi Shapour University Of Medical Sciences, University Town, Golestan
City
Ahvaz
Postal code
6135715794
Approval date
2016-07-02, 1395/04/12
Ethics committee reference number
IR.AJUMS.REC.1395.481
Health conditions studied
1
Description of health condition studied
Life Style
ICD-10 code
Z72
ICD-10 code description
Problems related to lifestyle
Primary outcomes
1
Description
Spiritual Growth
Timepoint
Befor And Immidiately After Intervention And Six Weeks Later
Method of measurement
HPLQ(Health Promotion Life Style Questionnare )
2
Description
Responsibility For Health
Timepoint
Befor And Immidiately After Intervention And Six Weeks Later
Method of measurement
HPLQ(Health Promotion Life Style Questionnare )
3
Description
Interpersonal Relationships
Timepoint
Befor And Immidiately After Intervention And Six Weeks Later
Method of measurement
HPLQ(Health Promotion Life Style Questionnare )
4
Description
Stress Management
Timepoint
Befor And Immidiately After Intervention And Six Weeks Later
Method of measurement
HPLQ(Health Promotion Life Style Questionnare )
5
Description
Sport
Timepoint
Befor And Immidiately After Intervention And Six Weeks Later Later
Method of measurement
HPLQ(Health Promotion Life Style Questionnare )
6
Description
Nutrition
Timepoint
Befor And Immidiately After Intervention And Six Weeks Later
Method of measurement
HPLQ(Health Promotion Life Style Questionnare )
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Eight sessions of cognitive - behavioral therapy in groups will be held in weekly meetings . The duration of each session will be 90 minutes. In these meetings, the influence of the thoughts on emotional and behavioral and The impact of negative thoughts on Lifestyle-related behaviors will be explained. Promoting healthy lifestyle before and after the consultation and 6 weeks after the intervention will be evaluated.
Category
Lifestyle
2
Description
Control group: Did not receive any treatment and only received usual care health. For observe ethical principles, Two sessions on menopause, its symptoms, lifestyle and its effects on menopausal symptoms as well as cognitive-behavioral therapy model for Control group will be held. Health promoting lifestyle of this group will be evaluated In these times( before and after the consultation and 6 weeks after)
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Number 1, East Center
Full name of responsible person
Shiva Yazdizadeh
Street address
Number 1, East Center, Street Shahid Rastegary, Haiway Behbehany Ayatollahh
City
Ahvaz
2
Recruitment center
Name of recruitment center
Number 2, West Center
Full name of responsible person
Shiva Yazdizadeh
Street address
South Sorrosh Street, Khashayar
City
Ahvaz
3
Recruitment center
Name of recruitment center
Number 14, East Center
Full name of responsible person
Shiva Yazdizadeh
Street address
Nuber 5, Shekofe Street, Ajajary Koy
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jondi Shapour University Of Medical Sciences
Full name of responsible person
Doctor Behzad Sharif Makhmalzadeh
Street address
Jondi Shapour University Of Medical Sciences, Research Center, Univehapour University Of Medical Sciences, Research Center, University Town, Golestan
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jondi Shapour 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
School Of Nursing And Midwifery Ahvaz
Full name of responsible person
Shiva Yazdizadeh
Position
Master In Midwifery
Other areas of specialty/work
Street address
School Of Nursing And Midwifery, Jondi Shapour University Of Medical Sciences, University Town, Golestan
City
Ahvaz
Postal code
6135715794
Phone
+98 933 196 2105
Fax
Email
shiva_yazdizadeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School Of Nursing And Midwifery
Full name of responsible person
Poorandokht Afshri
Position
Senior Midwifery
Other areas of specialty/work
Street address
School Of Nursing And Midwifery, Jondi Shapour University Of Medical Sciences, University Town, Golestan
City
Ahvaz
Postal code
6135715794
Phone
00
Fax
Email
p_afshary@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School Of Nursing And Midwifery
Full name of responsible person
Shiva Yazdizadeh
Position
Master In Midwifery
Other areas of specialty/work
Street address
School Of Nursing And Midwifery, Jondi Shapour University Of Medical Sciences, University Town, Golestan
City
Ahvaz
Postal code
6135715794
Phone
+98 933 196 2105
Fax
Email
shiva_yazdizadeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)