The effect of couple communication skills training using multimedia software on menopausal symptoms, quality of life and marital satisfaction among women in menopausal transition
Determining the effect of couple communication skills training using multimedia software on the severity of menopausal symptoms, quality of life and marital satisfaction in women of menopausal age
Design
Clinical trial with control group, with parallel groups, without blinding, random allocation on 84 samples
Settings and conduct
This study will be performed on 84 couples (each group has 42) in Gonabad city. The intervention group will receive a training program in 6 sections (2 hours each) in two sessions per week, but the control group will not receive any program. At the beginning of the study, after the training program and 12 weeks after the training program, both intervention and control groups will complete the menopause symptom severity, quality of life and marital satisfaction questionnaires. Blinding will not be performed in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
● Age 40 to 55 years
● Having written consent to participate in the study
● Having the ability to use WhatsApp Messenger
. Being married and living with a spouse
Exclusion criteria:
● Untimely death of a couple
● Absence of more than one session
Unwillingness to continue reading
Intervention groups
The intervention group includes couples in menopausal age who receive the intervention of the educational program.
The control group includes couples who are in menopause and do not receive the training program.
Main outcome variables
Severity of menopausal symptoms, quality of life and marital satisfaction in women of menopausal age
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211205053281N1
Registration date:2021-12-30, 1400/10/09
Registration timing:registered_while_recruiting
Last update:2021-12-30, 1400/10/09
Update count:0
Registration date
2021-12-30, 1400/10/09
Registrant information
Name
Akram Gholami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3130 8772
Email address
helya.gholami1397@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-11, 1400/09/20
Expected recruitment end date
2022-02-09, 1400/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of couple communication skills training using multimedia software on menopausal symptoms, quality of life and marital satisfaction among women in menopausal transition
Public title
The effect of training couples communication skills using multimedia software on menopausal symptoms, quality of life and marital satisfaction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
40-55 years old
having written consent to participate in the study
having literacy
having the ability to use WhatsApp messenger
being married and living with a spouse
not having hormone replacement therapy
no history of hysterectomy or ovariectomy
no Using herbal remedies to reduce menopausal symptoms
not being diagnosed with mental and sexual disorders (according to the participant)
not taking psychiatric drugs or addiction (according to the participant)
not having physical and ground disease In couples (such as cancer, cardiovascular disease, stroke)
no adverse life events in the last 6 months
Exclusion criteria:
Untimely death of one of the spouses
absence of more than one session
unwillingness to continue studying
Age
From 40 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
2 Comprehensive centers for providing health services based on the lottery, will be assigned to intervention groups (training of couple communication skills using multimedia software) and control group (one center each). Then in the centers, samples will be entered into the study based on available (easy) sampling. Randomization is simple and the randomization units are clustered and randomization is done by tossing coins.
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 of Gonabad University of Medical Sciences
Street address
Phase Two Army
City
birjand
Province
South Khorasan
Postal code
9744163459
Approval date
2021-11-13, 1400/08/22
Ethics committee reference number
IR.GMU.REC.1400.106
Health conditions studied
1
Description of health condition studied
Menopausal and other perimenopausal disorders
ICD-10 code
N95
ICD-10 code description
Menopausal and other perimenopausal disorders
Primary outcomes
1
Description
Severity of menopausal symptoms
Timepoint
At the beginning of the study, immediately after the intervention, three months after the intervention
Method of measurement
Menopause Symptoms Rating Scale
Secondary outcomes
1
Description
Quality of life
Timepoint
At the beginning of the study, immediately after the intervention, three months after the intervention
Method of measurement
Quality of life questionnaire
2
Description
Marital Satisfaction
Timepoint
At the beginning of the study, immediately after the intervention, three months after the intervention
Method of measurement
Marital Satisfaction Questionnaire
Intervention groups
1
Description
Intervention group: Forming an intervention group in WhatsApp software, conducting training programs in 6 sections (2 hours each section) during two sessions per week for the participants of the intervention group. Intervention in the multimedia group will be as follows: A schedule will be provided to the intervention group, according to which the training sections will be sent to them in WhatsApp messenger (separately for each couple). Each educational section will include educational materials prepared according to the program along with images, audio, content, videos, etc., which will help to better understand the content. The scientific content of the educational program sections will be prepared using the latest reference books and also according to the content of the booklets and educational materials published by the Ministry of Health and Medical Education and will be available to 10 reproductive health specialists and gynecologists for approval. And counseling will be included. The topics of the sessions include: introducing the expression of goals and methods of work, self-awareness, recognizing the healthy personality, the importance of self-confidence, marital life skills, heart dialogue, intimacy, love commitment, intimacy, resilience conflict, satisfying sexual relaxation
Category
Behavior
2
Description
Control group: Form a control group in WhatsApp software. Only PDF tutorials are included in this group and also three questionnaires to complete
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Gonabad Urban Community Health Centers
Full name of responsible person
Gonabad University of Medical Sciences
Street address
Gonabad - Asian Roadside - University Campus
City
Gonabad
Province
Razavi Khorasan
Postal code
1256897451
Phone
+98 51 5722 4083
Email
helya.gholami1397@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Narjes bahri
Street address
Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9156137374
Phone
+98 51 5722 0575
Email
nargesbahri@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Akram gholami
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Phase Two Army
City
Birjand
Province
South Khorasan
Postal code
9744163459
Phone
+98 56 3130 8772
Email
helya.gholami1397@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Narjes bahri
Position
Faculty member of Gonabad University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Gonabad - Asian Roadside - University Campus
City
Gonabad
Province
Razavi Khorasan
Postal code
000000000000000
Phone
+98 51 5722 0575
Email
nargesbahri@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Akram gholami
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Phase Two Army
City
Birjand
Province
South Khorasan
Postal code
9744163459
Phone
+98 56 3130 8772
Email
helya.gholami1397@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