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The effect of group counseling with hope-oriented approach on the quality of life and anxiety of women with overt diabetes

Protocol summary

Study aim
Determining the effect of counseling with a hope-based approach on the quality of life and anxiety of pregnant mothers with diabetes is obvious.
Design
Randomized clinical trial of two groups in two groups of control and intervention, which was conducted by available sampling method and randomization with Randomization.com site and block of 4.
Settings and conduct
In this research, referring to Umm al-Binin , Imam Reza and Qaim hospitals, pregnant mothers with overt diabetes who are eligible to enter the study are divided into two intervention and control groups using available sampling method.
Participants/Inclusion and exclusion criteria
Resident of Mashhad, no medical diseases or mental disorders, obvious diabetes, gestational age 18-26 weeks, able to communicate verbally, at least fifth grade education, access to the Internet, owning a mobile phone or laptop, singleton pregnancy, no Severe anxiety and the absence of stressful events
Intervention groups
For the intervention group, in addition to routine care such as fetal health test (NST), ultrasound in terms of fetal growth and AFI examination, nutrition counseling and receiving appropriate medications according to the doctor's opinion, 6 hope-based group counseling sessions in virtual groups of 10 people 60-90 minutes It is done once a week
Main outcome variables
Quality of life- anxiety-pregnancy anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240522061872N1
Registration date: 2024-06-19, 1403/03/30
Registration timing: prospective

Last update: 2024-06-19, 1403/03/30
Update count: 0
Registration date
2024-06-19, 1403/03/30
Registrant information
Name
Bahareh Erfanian Shahabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3606 6504
Email address
erfaniansb3@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group counseling with hope-oriented approach on the quality of life and anxiety of women with overt diabetes
Public title
Investigating the effect of hope-based counseling on the quality of life and anxiety of pregnant mothers with diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
A resident of Mashhad Not suffering from medical diseases and mental disorders Overt diabetes Gestation age 18-26 weeks Able to communicate At least fifth grade literacy singleton pregnancy Absence of severe anxiety Internet access Having a mobile phone or laptop
Exclusion criteria:
The presence of severe anxiety Having obstetrical problems such as fetal abnormalities, preeclampsia
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The research units are divided into two intervention and control groups, according to the random sequence generated by the Randomization.com website and 4 blocks. In order to hide the assignment of the groups, the codes related to the intervention and control groups will be placed in a sealed envelope.
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 Mashad University of Medical Sciences
Street address
No. 402, 28 FaramarzAbbasi., FaramarzAbbasi Blvd., Mashad
City
mashad
Province
Razavi Khorasan
Postal code
9197939699
Approval date
2024-05-06, 1403/02/17
Ethics committee reference number
IR.MUMS.NURSE.REC.1403.010

Health conditions studied

1

Description of health condition studied
Diabetes mellitus in pregnancy
ICD-10 code
O24.91
ICD-10 code description
Unspecified diabetes mellitus in pregnancy

Primary outcomes

1

Description
Quality of life score of sf-12 questionnaire
Timepoint
In this study, quality of life is measured before the start of the intervention, at the end of the intervention and one month after the end of the intervention
Method of measurement
Using the sf-12 quality of life questionnaire

2

Description
Anxiety score based on Vandenberg pregnancy anxiety questionnaire
Timepoint
In this study,Pregnancy anxiety is measured before the start of the intervention, at the end of the intervention and one month after the end of the intervention
Method of measurement
Using the Vandenberg Pregnancy Anxiety Questionnaire

3

Description
General anxiety score based on Beck anxiety questionnaire
Timepoint
In this study,anxiety is measured before the start of the intervention, at the end of the intervention and one month after the end of the intervention
Method of measurement
Using Beck's anxiety questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:In addition to routine care such as: pregnancy care, receiving insulin, taking NST, ultrasound and laboratory tests, they receive 6 counseling sessions with a hope-oriented approach, one session a week virtually.
Category
Other

2

Description
Control group: They receive routine care such as: pregnancy care, receiving insulin, taking NST, doing ultrasound and laboratory tests.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Qaem hospital
Full name of responsible person
Dr. Hossein Mohsenzadeh
Street address
Mashhad, Shariati Square, the beginning of Ahmedabad Street
City
Mashad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
Quaem.Medical.Center@mums.ac.ir

2

Recruitment center
Name of recruitment center
Ommolbanin Hospital
Full name of responsible person
Dr. Munira Porjavad
Street address
Mashhad - Zarineh Crossroad - corner of Ayatollah Behjat 16 - Hazrat Umm Albinin Women's Hospital
City
Mashad
Province
Razavi Khorasan
Postal code
٩١۴۴٧٣۴٧۶٧
Phone
+98 51 3223 1061
Email
oah@mums.ac.ir

3

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Mohammad Hosseini
Street address
Razavi Khorasan Province, Mashhad, Ebne Sina St,
City
Mashad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Email
ImamRezaHospital@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Daneshgah Street, Central Organization of Mashhad University of Medical Sciences
City
Mashad
Province
Razavi Khorasan
Postal code
١٣٩۴۴ ٩١٣٨٨
Phone
+98 51 3841 2081
Email
presidentoffice@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
Samira Ebrahimzadeh Zaghmi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Mashhad, Azadi Square, East Gate of Ferdowsi University of Mashhad, University Campus, Shahid Dr. Kharazmi Educational Complex
City
Mashad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
EbrahimzadehZS@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Samira Ebrahimzadeh Zaghmi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Mashhad, Azadi Square, East Gate of Ferdowsi University of Mashhad, University Campus, Shahid Dr. Kharazmi Educational Complex
City
Mashad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
EbrahimzadehZS@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Samira Ebrahimzadeh Zaghmi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Mashhad, Azadi Square, East Gate of Ferdowsi University of Mashhad, University Campus, Shahid Dr. Kharazmi Educational Complex
City
Mashad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
EbrahimzadehZS@mums.ac.ir

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
There is no more information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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