Determining the effect of menopause complications training to husbands on physical_psychological experiences in postmenopausal women
Design
Randomized, controlled clinical trial study on 150 eligible postmenopausal women.
Settings and conduct
Eligible samples will be identified by health volunteers in Mashhad, then randomly assigned by the researcher to the control and intervention groups. Before the intervention, women will complete the form of demographic questionnaire and the form of measuring the physical-psychological experiences of women in menopause and their husbands will complete the form of knowledge assessment. One month after the end of the intervention, they will complete the questionnaire of assessing the physical-psychological experiences of women in menopause and their husbands will complete the form of knowledge assessment of menopausal complications.
Participants/Inclusion and exclusion criteria
Inclusion criteria: menopause women, No history of physical or mental illness during the past 6 months, No ovarian and uterine surgery in the last 6 months. Living with a husband, using hormonal medications. Inclusion criteria for spouses: the literacy of reading and writing; No previous reception of curriculum or a book about menopause.
Intervention groups
Intervention: 3 sessions (one-hour) group training, Within a week, by lecture (with slides) and question-answer about the nature and complications of menopause and teaching pamphlets menopause in addition to health center routine program. Control group; Receive routine health center program
Main outcome variables
Physical psychological experiences
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180509039595N2
Registration date:2018-11-07, 1397/08/16
Registration timing:retrospective
Last update:2018-11-07, 1397/08/16
Update count:0
Registration date
2018-11-07, 1397/08/16
Registrant information
Name
Mahdieh Ebrahimzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5543 1083
Email address
ebrahimzadehm6@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-30, 1397/05/08
Expected recruitment end date
2018-09-30, 1397/07/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of menopause complications training to husbands on physical_psychological experiences in postmenopausal women
Public title
The effect of menopause complications training to husbands on physical_psychological experiences in postmenopausal women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Living with spouse
Spouses have literacy to read and write
Exclusion criteria:
Ovarian and uterine surgery in the last 6 months
Use of hormonal drugs
History of physical or mental illness in the last 6 months
Husbands who have already studied a curriculum, book, pamphlet or educational pamphlet about menopause.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were selected by convenience sampling and random allocation was made to divide samples to two groups (intervention and control). By selection the cards by patients, number one (the intervention group) and number two (control group) random allocation was performed. This act continued until the required number of samples was recruited.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Mashhad University of Medical Sciences
Street address
University Street, Quraishi Building
City
Mashhad
Province
Razavi Khorasan
Postal code
91735-951
Approval date
2018-06-19, 1397/03/29
Ethics committee reference number
IR.MUMS.REC.1397.039
Health conditions studied
1
Description of health condition studied
Menopause
ICD-10 code
N95
ICD-10 code description
Menopausal and other perimenopausal disorders
Primary outcomes
1
Description
Physical - psychological experiences of postmenopausal women
Timepoint
Before the intervention and one month after the last intervention
"Intervention group":3 sessions (one-hour) group training, Within a week, by lecture (with slides) and question-answer about the nature and complications of menopause and teaching pamphlets menopause in addition to health center routine program.
Category
Lifestyle
2
Description
Control group: Receive routine health center program
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center No. 1
Full name of responsible person
Dr. Nasser Amini
Street address
Vakil Abad Boulevard, next to Urban City
City
Mashhad
Province
Razavi Khorasan
Postal code
9185684538
Phone
+98 51 3501 8011
Email
aminin1@mums.ac.ir
Web page address
http://ch-mashhad1-mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Bibi Sadiqa Sharia Moghani
Street address
University, Faculty of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9913197319
Phone
+98 51 3859 1511
Email
shariatmoghanis@mums.ac.ir
Web page address
htp://mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mahdieh Ebrahimzadeh
Position
Graduate Student, Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
University of Nursing, Faculty of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9177116763
Phone
+98 51 3859 1511
Email
ebrahimzadehm6@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mashhad University of Medical Sciences
Position
Graduate Student, Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
University of Nursing, Faculty of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9177116763
Phone
+98 51 3859 1511
Email
ebrahimzadehm6@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdieh Ebrahimzadeh
Position
Graduate Student, Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
University of Nursing, Faculty of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9177116763
Phone
+98 51 3859 1511
Email
ebrahimzadehm6@mums.ac.ir
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