Protocol summary

Study aim
Determine the effect of self-care education on health promoting lifestyle in postmenopausal women
Design
In this study, 84 samples of postmenopausal women referring to Qazvin comprehensive health centers are randomly divided into intervention and control groups and each participant is assigned a code.
Settings and conduct
In this study, among postmenopausal women referring to these centers, if they had the inclusion criteria by random allocation method, they were divided into intervention and control groups, and after obtaining written informed consent, a questionnaire for demographic information, a light measurement questionnaire Health promotion life is completed in two groups. In the intervention group, filling the health promotion lifestyle questionnaire in one and two months after the end of the intervention, and in the control group only filling in the questionnaire in one and two months later.
Participants/Inclusion and exclusion criteria
Criteria for entering the study: Natural menopause, passing one year from the last menstruation, non-participation in other similar studies, having a contact number for follow up, ability to speak in Persian, The desire to participate in the study Exit criteria: the use of any alternative hormone drugs in the past 3 months or during the study, receiving any training on menopause, by other means , The need for surgical interventions, mental illness, according to the person in the last 6 months, the use of alcohol or tobacco (cigarettes, hookahs, etc.), the use of a particular diet (water therapy, vegetarianism, crustaceans and so on). ..)
Intervention groups
The intervention group, 4 sessions, 60 to 90 minutes, will have a group of 5 to 12 people. A booklet is presented in accordance with the educational materials.
Main outcome variables
Health promoting lifestyle

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180408039234N1
Registration date: 2018-10-01, 1397/07/09
Registration timing: retrospective

Last update: 2018-10-01, 1397/07/09
Update count: 0
Registration date
2018-10-01, 1397/07/09
Registrant information
Name
Reihane Sadat mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2244 3980
Email address
reihane.mmw@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Self-care education on health promoting lifestyle in postmenopausal women in Qazvin in 1997
Public title
The effect of self-care on improving the health of postmenopausal women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Postmenopausal natural Pass one year of the last menstruation Not participating in other similar studies Calling number to track Ability to speak Persian At least 45 years old
Exclusion criteria:
Taking any alternative hormone drugs in the last 3 months or during the study Get any training on menopause, in other ways Need for surgical intervention Mental illness, according to a person in the last 6 months The appearance of any spotting in the last year Use of alcohol or tobacco (cigarettes, hookahs, etc.) Use a special diet (water therapy, vegetarianism, raw food, etc.)
Age
From 45 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
The study will use a multi-stage sampling method. First, the city of Qazvin, according to its urban areas, is divided into 3 urban areas and one of the centers of urban health in each region is randomly selected cluster center and from among postmenopausal women referring to these centers The available form will be sampled and women will be included in the study if they meet the criteria for entering the study after completing the written consent. They are then randomly allocated into two groups of intervention and control, in which 84 pieces of paper are written on half of that control word and the other half of the intervention written by the person after signing the consent from one of the envelopes of the paper. has it
Blinding (investigator's opinion)
Single blinded
Blinding description
Blind technique is used to reduce possible bias in the results. Blindness should be done correctly, ie groups that have the potential to cause bias in the study, our study priority is to be blinded one by one and the information analyst is not aware of the control or interference of the samples. Samples in both groups are aware of which groups are in the study. The researcher also has the knowledge to provide the training in the intervention group.The information analyzer receives information in the form of numerical codes in two groups, because their control or intervention is unknown.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Unit 21، Sepid Tower، Arash Alley، Farhangian Alley،Noobhar Street، Azhgol، Tehran
City
Qazvin
Province
Qazvin
Postal code
1696815479
Approval date
2018-01-04, 1396/10/14
Ethics committee reference number
IR.QUMS.REC.1396.362

Health conditions studied

1

Description of health condition studied
Lifestyle Improvement Health
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Lifestyle Improvement Health
Timepoint
At the beginning of the study (before the intervention), one month and a half and three months later
Method of measurement
Health Promotion Lifestyle Assessment Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
"Intervention group:" Education sessions for postmenopausal women will be based on the sub-scales of the health promotion lifestyle questionnaire. These scales include nutrition, physical activity, stress management, health responsibility, interpersonal relationships, and spiritual growth. The training sessions will take place in four sessions in four weeks, and the duration of the sessions is 60 to 90 minutes. The sessions will be held in groups of 12 to 5, and at the end of each meeting, questions will be answered as needed. To increase the impact of education and help to get a better understanding of the booklet in this area related to the topics discussed. In this curriculum, the self-care education content of the Ministry of Health and Medical Education, which is provided by the Vice-Chancellor, and the Clinical Guide and Executive Program of the Health Team for the provision of menopause services to women aged 45-60, will be used as a teacher's guide. Also, in order to better understand the concepts, part of the training was a question and answer. At the end of each session, a brief educational pamphlet will be provided to the participants on the content presented at the meeting. This training will be carried out in Qazvin comprehensive health centers. In the intervention group, filling in the health promotion lifestyle questionnaire will be done one and two and three months after the end of the intervention.
Category
Lifestyle

2

Description
Control group: Control group: In this group, receiving routine care provided by comprehensive health centers. At the beginning of the study, filling in the health promotion lifestyle questionnaire, and repeating this questionnaire in one and two and three months later.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Qazvin City Health Centers
Full name of responsible person
Reyhana Sadat Mousavi
Street address
Shahid Bahonar Blvd، Qazvin
City
قزوین
Province
Qazvin
Postal code
1696815479
Phone
+98 28 3323 7267
Email
reihane.mmw@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Nasim Bahrami
Street address
Qazvin University of Medical Sciences and Health Services،Shahid Bahonar Blvd، Qazvin
City
Qazvin
Province
Qazvin
Postal code
1696815479
Phone
+98 28 3323 7267
Email
reihane.mmw@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Reyhana Sadat Mousavi
Position
Senior Counseling Midwifery Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Qazvin University of Medical Sciences، Shahid Bahonar Blvd، Qazvin
City
Qazvin
Province
Qazvin
Postal code
1696815479
Phone
+98 28 3323 7267
Email
reihane.mmw@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Reyhana Sadat Mousavi
Position
Senior Counseling Midwifery Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Qazvin University of Medical Sciences، Shahid Bahonar Blvd،Qazvin
City
Qazvin
Province
Qazvin
Postal code
1696815479
Phone
+98 28 3323 7267
Email
reihane.mmw@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Reyhana Sadat Mousavi
Position
Senior Counseling Midwifery Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ghazvin University of Medical Sciences, Qazvin, Shahid Bahonar Blvd،Qazvin
City
Qazvin
Province
Qazvin
Postal code
1696815479
Phone
+98 28 3323 7267
Email
reihane.mmw@gmail.com

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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