According to high prevalence of gestational diabetes and negative effect of stress on gestational diabetes and quality of life in women with gestational diabetes, this study aims to determine the impact of group counseling with problem solving approach on perceived stress and quality of life in women with gestational diabetes. People under study will be women with gestational diabetes who refered to Valiaser and Ayatollah Mousavi Hospital. At first they will be chosen through easy sampling and will be screened through oral glucose tolerance test to identify gestational diabetes. Finally 76 women with gestational diabetes will be selected for study and will be randomly divided into 2 intervention and control groups. Randomization will be done through block randomization method. Intervention group: Problem- Solving counselling in the intervention group is planned through six 45-60 minute sessions (two sessions every 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. 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. After a month, perceived stress and quality of life questionnaires will be filled by participants. Main outcomes: stress, quality of life.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016101227994N2
Registration date:2017-11-19, 1396/08/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-19, 1396/08/28
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
Vice chancellor for research,Zanjan University of Medical Sciences
Expected recruitment start date
2017-09-16, 1396/06/25
Expected recruitment end date
2018-11-03, 1397/08/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group counselling with problem solving approach on perceived stress and quality of life in 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
3
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
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 University of Medical Sciences
Street address
Azadi Square- Zanjan
City
Zanjan
Postal code
Approval date
2017-08-22, 1396/05/31
Ethics committee reference number
ZUMS.REC.1396.141
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
Stress
Timepoint
Befor intervention, at the last consultation session and one month after intervention
Method of measurement
Cohen perceived stress quastionnaire
Secondary outcomes
1
Description
Quality of life
Timepoint
Before intervention, at the last consultation session and one month after intervention
Method of measurement
World Health Organization Quality of Life quastionnaire
Intervention groups
1
Description
Intervention group: Problem- Solving counselling in the intervention group is planned through six 45-60 minute sessions (two sessions every 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
Behavior
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
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Clinic, Valiaser Hospital
Full name of responsible person
Sara Maki
Street address
Valiaser Hospital, Valiaser Square, Zanjan
City
Zanjan
2
Recruitment center
Name of recruitment center
Elective ward, Ayatollah Mousavi Hospital
Full name of responsible person
Sara Maki
Street address
Ayatollah Mousavi Hospital, Gavazang Road
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chacellor for research, University of Medical Sciences
Full name of responsible person
Doctor Alireza Shoghli
Street address
Zanjan University of Medical Sciences, Azadi Square, Zanjan
City
Zanjan
Grant name
پایان نامه
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chacellor for research, University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Sara Maki
Position
Senior Counselling Student in Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Carmandan Boulevard, Zanjan
City
Zanjan
Postal code
4513715913
Phone
+98 24 3345 0992
Fax
Email
saramaki2016@gmail.com
Web page address
www.zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Taraneh Emamgoli khooshehchin
Position
PhD
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Carmandan Boulevard, Zanjan
City
Zanjan
Postal code
Phone
+98 24
Fax
Email
khoosheh@zums.ac.ir
Web page address
www.zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Sara Maki
Position
Senior counselling student in Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Carmandan Boulevard, Zanjan
City
Zanjan
Postal code
4513715913
Phone
+98 24 3345 0992
Fax
Email
saramaki2016@gmail.com
Web page address
www.zums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)