Determining the effect of group counseling with problem solving approach on self- efficacy and self-care of women with gestational diabetes
Design
The study is a randomized controlled clinical trial. Initially, sampling will be carried out by convenience method. Qualified individuals will be divided into two intervention and control groups using randomized blocking. The number of samples in each group is 35 people.
Settings and conduct
The population of this study will be the women with gestational diabetes mellitus with gestational age of 24-30 weeks treated with insulin or diet that will be referred to diabetes clinic of Vali-e-Asr Hospital and Mousavi Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with gestational diabetes with gestational age of 24-30 weeks; No other diseases; Without any history of the diseases; Absence of mental illness; Having reading and writing skills; The absence of major stressful events during the recent pregnancy/Exclusion criteria: Unwillingness to continue to study; Absence of complications and problems associated with pregnancy; Presence of diabetes mellitus before pregnancy
Intervention groups
For the intervention group, the problem-solving counseling session will be organized in 6 sessions for 60-45 minutes, once a week and for the control group, routine pregnancy care will be provided. In group counseling, the number of members will be 12 in consultation sessions. After the interventions and reviewing the results for the control group, counseling sessions will also take place. Prior to conducting counseling sessions, after final consultation session and 1 month after the consultation, questionnaires will be filled by both groups.
Main outcome variables
Self- Efficacy And Self-care
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160521027994N5
Registration date:2018-07-27, 1397/05/05
Registration timing:registered_while_recruiting
Last update:2018-07-27, 1397/05/05
Update count:0
Registration date
2018-07-27, 1397/05/05
Registrant information
Name
Taraneh Emamgholi khooshehchin
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3314 8318
Email address
khoosheh@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2018-10-07, 1397/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group counseling with problem solving approach on self- efficacy and self-care of women with gestational diabetes
Public title
The impact of group counselling on gestational diabetes mellitus
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women with gestational diabetes with gestational age of 24-30 weeks; No other diseases; Without any history of the diseases; Absence of mental illness; Having reading and writing skills; The absence of major stressful events during the recent pregnancy
Exclusion criteria:
Unwillingness to continue to study; Absence of complications and problems associated with pregnancy; Presence of diabetes mellitus before pregnancy
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
More than 1 sample in each individual
Number of samples in each individual:
70
70 person
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization will be done by table of random numbers
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
A randomized blocked design
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan Medical Uneversity
Street address
Zanjan Azadi Square
City
Zanjan
Province
Zanjan
Postal code
4513956113
Approval date
2018-06-20, 1397/03/30
Ethics committee reference number
IR.ZUMS.REC.1397.049
Health conditions studied
1
Description of health condition studied
Gestational Diabetes
ICD-10 code
024
ICD-10 code description
Diabetes mellitus in pregnancy
Primary outcomes
1
Description
Self-Efficacy And Self-care
Timepoint
Befor intervention, at the last consultation session and one month after intervention
Method of measurement
Diabetes Self-Efficacy Inventory (DMSES), Glasgow's Diabetes Self-care and Tuber quastionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:The problem-solving counseling session in the intervention group will be held in group sessions in six sessions of 45-60 minutes, once a week. The number of members in each group for group counselling will be 12 people and at the end of each session, some exercises will be given to the participants.
Category
Other
2
Description
Control group: In the control group, routine pregnancy care will be provided. If the participants of the control group want, problem- solving counselling sessions will also be held for them after the final stage
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Clinic, Valiaser Hospital
Full name of responsible person
Shahla Osali
Street address
Valiaser Hospital, Valiaser Square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
Email
osali.sh@yahoo.com
2
Recruitment center
Name of recruitment center
Elective ward, Ayatollah Mousavi Hospital
Full name of responsible person
Shahla Osali
Street address
Ayatollah Mousavi Hospital, Gavazang Road
City
Zanjan
Province
Zanjan
Postal code
4513956113
Email
osali.sh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Doctor Alireza Shoghli
Street address
Zanjan University of Medical Sciences, Azadi Square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 3314 8318
Email
khoosheh@zums.ac.ir
Web page address
Grant name
tesis
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
Shahla Osali
Position
Senior Counselling Student In Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School Of Nursing and Midwifery, Carmandan Boulevard, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515656711
Phone
+98 24 3344 1446
Email
osali.sh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Taraneh Emamgoli Khooshehchin
Position
Faculty
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School Of Nursing And Midwifery, Carmandan Boulevard, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 3314 8318
Email
khoosheh@zums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Shahla Osali
Position
Senior Counselling Student In Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School Of Nursing And Midwifery, Carmandan Boulevard, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513715913
Phone
+98 24 3344 1446
Email
osali.sh@yahoo.com
Web page address
https://zums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
The release program is not yet known
When the data will become available and for how long
The release program is not yet known
To whom data/document is available
The release program is not yet known
Under which criteria data/document could be used
The release program is not yet known
From where data/document is obtainable
The release program is not yet known
What processes are involved for a request to access data/document