Investigating the effect of a Life Skills program on the Feeling Old and self-efficacy of Menopausal women referring to selected centers of Isfahan in 2019
Design
A clinical trial with a control group, with parallel, randomized, and outcome assessment
Settings and conduct
In this clinical trial study, 208 individuals were selected by convenience sampling method from postmenopausal women referring to the centers and according to the characteristics recorded in the SIB system. Finally, 70 participants were selected based on inclusion criteria Then they were randomly assigned to the experimental and control groups based on the last number of the national code. The life skills program was held in 5 sessions for 5 weeks at the Navab and Imam Ali centers.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Ability to communicate؛ Willingness to participate in the study؛ Having the physical and psychological ability to participate in the study؛ Lack of mental illness and general health؛ Minimum literacy skills؛ Age between 46 and 55 years and at least one year past their last menstruation؛ Being married and having children؛ Lack of crisis and stress over the past 6 months؛ Refusal to participate in other psychotherapy programs . Exclusion criteria of the study: Menopause is followed by surgery and removal of the ovaries؛Absent more than two sessions؛ Physical inability to attend meetings.
Intervention groups
Intervention group: Run 5 group sessions with promote Life Skills Program contenty. Control group: Run 2 group sessions and talk about the experiences and effects of menopause
Main outcome variables
Feeling Old and Self-Efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200227046628N1
Registration date:2020-03-10, 1398/12/20
Registration timing:retrospective
Last update:2020-03-10, 1398/12/20
Update count:0
Registration date
2020-03-10, 1398/12/20
Registrant information
Name
Jahangir Maghsoudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7566
Email address
maghsoudi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-13, 1398/03/23
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
2019-06-13, 1398/03/23
Actual recruitment end date
2019-06-13, 1398/03/23
Trial completion date
2019-08-19, 1398/05/28
Scientific title
Investigating the Effect of a Life Skills Program on Feeling Old and Self-Efficacy in Menopausal women
Public title
Investigating the Effect of a Life Skills Program on the Feeling Old and Self-Efficacy of Menopausal women referring to selected centers of Isfahan in 2019
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
They should be able to communicate
They should be willing to participate in the study
They should have the physical and mental capacity to participate in the study
Lack of mental illness and general health of research units according to the SIB system
Participants should have minimum literacy skills
Participants between the ages of 46 and 55 should be selected and at least one year has passed since their last menstruation
Participants should not participate in Psychotherapy programs during the study
The specialists should not be under the supervision of Menopausal Symptoms
Participants should not experience crisis and stress during the 6 months before the start of the study.
Participants must be married and had children
Exclusion criteria:
Participants do not attend the program for two consecutive sessions
Participants are unable to attend meetings for physical reasons
Menopause is followed by surgery and removal of the ovaries
Age
From 46 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Actual sample size reached:
69
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of samples was done in two groups of experimental and control according to the prepared list and the last number of National Code of individuals, even numbers were assigned to the experimental group and odd numbers 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 Isfahan University Of Medical Sciences Faculty Of Nursing and Midwiery
Street address
Isfaha University Of Medical Sciences Faculty Of Nursing and Midwiery , Hezar Jreb avenue , Isfahan
Intervention group: Intervention in the experimental group was implemented as Life Skills Program in 5 sessions of 60 minutes over a period of 5 weeks (one session per week) in groups of 17-18, using lecture, group discussion, presentation Movies and slideshows and role plays will be held in the classroom. The content of the sessions is the same for all groups and all study groups provide an educational pamphlet based on the subject of each session, and they are asked to practice the homework daily until the next session, and at the beginning of the next meeting, the discussions will be held. It also continually monitors and controls the interval between sessions to ensure that the exercises are carried out
Category
Behavior
2
Description
Control group: In order to eliminate the possible effects of the presence of individuals in a group, 2 sessions will be held on the topic of Menopause and its experiences, effects and challenges, without reference to the Life Skills component.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali ibe Abi Talib Health Center
Full name of responsible person
Mortaza Ghasemi
Street address
west Toosi St, Second 24 Metri St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8198883982
Phone
+98 31 3555 1030
Fax
+98 31 3559 3229
Email
health-1@mui.ac.ir
Web page address
https://hlth1.mui.ac.ir/
2
Recruitment center
Name of recruitment center
Shahid Navaab Safavi Health Center
Full name of responsible person
Ali Asghar Sadeghian
Street address
Bozorgmehr St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8156735975
Phone
+98 31 3227 5365
Fax
+98 31 3227 5288
Email
health-1@mui.ac.ir
Web page address
https://hlth1.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fariba Taleghani
Street address
Faculty of Nursing and Midwifery; Isfahan Univ ersity of Medical Sciences; Azadi Square, Hezar Jirib St; Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7565
Fax
+98 31 3669 9398
Email
taleghani@nm.mui.ac.ir
Web page address
http://nm.mui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Dibaj
Position
MSC student of nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
sfahan University Of Medical Sciences Faculty Of Nursing and Midwiery , Hezar Jreb avenue , Isfahan , Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3230 2534
Email
zahradibaj96@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Jahangir Maghsoudi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Isfahan University Of Medical Sciences Faculty Of Nursing and Midwiery , Hezar Jreb avenue , Isfahan , Iran
City
Isfahan
Province
Isfehan
Postal code
8174673465
Phone
+98 31 3792 7566
Email
maghsoudi@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Dibaj
Position
MSC student of nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Isfahan University Of Medical Sciences Faculty Of Nursing and Midwiery, Hezar Jreb avenue, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673465
Phone
0098 32302534
Email
zahradibaj.zd@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The information obtained during the investigation is the responsibility of the author.