The effects of motivational interviewing focused on some principles of Hefz – Alsehe in Persian medicine on stress and quality of life of infertile women
Determining the effects of motivational interviewing focused on some principles of Hefz – Alsehe in Persian medicine on stress and quality of life of infertile women
Design
From all women who meet the inclusion criteria, 56 participants will be selected by convenient method and allocated to two control and intervention groups by stratified random method according to primary and secondary infertility in four-person blocks.
Settings and conduct
Sampling will be done in Ayatollah Mousavi Hospital Infertility Clinic. Firstly, 56 eligible women will be selected by convenience Method and then participants will be allocated to two control and intervention groups by stratified random method according to primary and secondary infertility in four-person blocks. Participants will complete the questionnaires as a self-report before the intervention, immediately after the sessions and three months after the last consultation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having at least reading and writing literacy; informed participation of research participants; medical diagnosis of female factor infertility; age range from 20 to 40 years old; obtaining a stress score of 92 and above based on Newton's infertility stress questionnaire. Exclusion criteria: Male infertility factor; having a divorce case or marital dispute,
A history of known mental illness; people who don't want to continue participating in the study or don't participate in more than one counseling session.
Intervention groups
The intervention group includes motivational counseling with the content of some principles of Hefz – Alsehe of Iranian medicine. Motivational interviewing sessions will be held individually during five weekly and face-to-face meetings. The maximum time of each session is 45 minutes.
Main outcome variables
Stress; quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160608028352N13
Registration date:2023-11-28, 1402/09/07
Registration timing:prospective
Last update:2023-11-28, 1402/09/07
Update count:0
Registration date
2023-11-28, 1402/09/07
Registrant information
Name
Roghieh Kharaghani
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3314 8144
Email address
r.kharaghani@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-09, 1402/09/18
Expected recruitment end date
2024-05-19, 1403/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of motivational interviewing focused on some principles of Hefz – Alsehe in Persian medicine on stress and quality of life of infertile women
Public title
The effects of motivational interviewing focused on some principles of Hefz – Alsehe in Persian medicine on stress and quality of life of infertile women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least reading and writing literacy
Informed participation of research participants
Medical diagnosis of female factor infertility
Age range from 20 to 40 years
Obtaining a stress score of 92 and above based on Newton's infertility stress questionnaire
Exclusion criteria:
Male infertility factor
Having a divorce case or marital dispute
A history of known mental illness
People who don't want to continue participating in the study or don't participate in more than one counseling session.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method will be convenient. The participants will be allocated to two control and intervention groups by stratified random method according to primary and secondary infertility in four-person blocks. The sample size in the two groups is 56 participants, so the allocation of participants in the intervention and control groups by random selection of 14 four-person blocks (50 people) will be done.The selection of each block will be done using random table numbers.
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
The Ethics Committee of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, north side of Azadi Blvd.
City
Zanjan
Province
Zanjan
Postal code
4525613113
Approval date
2023-11-15, 1402/08/24
Ethics committee reference number
IR.ZUMS.REC.1402.196
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Stress
Timepoint
Before the intervention, immediately after the intervention and three months after the last counseling
Method of measurement
Questionnaire of Fertility problem inventory
2
Description
Quality of Life
Timepoint
Before the intervention, immediately after the intervention and three months after the last counseling
Method of measurement
Questionnaire of fertility quality of life tool
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention includes motivational counseling with the content of some principles of Hefz – Alsehe of Iranian medicine. These principles include proper physical activity, eating and drinking, and sleep management. Motivational interviewing sessions will be held individually during five weekly and face-to-face meetings. The maximum time of each session is 45 minutes.
Category
Lifestyle
2
Description
Control group: Participants in this group will not receive any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital Infertility Clinic
Full name of responsible person
Maede Feizy
Street address
Ayatollah Mousavi Hospital, Road Gavazang
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 901 511 0062
Email
feizymaede788@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Samad Nadri
Street address
Chancellor for Reasearch and Technology of Zanjan University of Medical Sciences, First floor, Northside Boulevard Azadi, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8300
Email
nadri_s@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Maede Feizy
Position
Master's student in counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Zanjan University of Medical Sciences, Gavazang Road, Zanjan, Iran
City
zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3372 5797
Email
feizymaede788@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Roghieh Kharaghani
Position
Ph.D of Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Zanjan University of Medical Sciences, Gavazang Road
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8300
Email
r.kharaghani@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Maede Feizy
Position
Master's student in counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Zanjan University of Medical Sciences, Gavazang Road
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3372 5797
Email
feizymaede788@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
After completion of the study, information on the main outcome will be shared.
When the data will become available and for how long
Starting the access period from 2024
To whom data/document is available
Data and documentation will be available to medical researchers.
Under which criteria data/document could be used
The data can be used to study, give a citation, create new ideas, and practically apply in medical centers.
From where data/document is obtainable
Email to feizymaede788@gmail.com
What processes are involved for a request to access data/document
The data will be provided to the applicant within one month after reviewing and confirming the request.