Determining the effect of perceived disease-based intervention on perceived stress in women with gestational diabetes
Design
In this study, 80 samples of women with gestational diabetes mellitus admitted to the prenatal department of Alzahra Hospital in Rasht are randomly assigned to two intervention and control groups and each participant is assigned a code.
Settings and conduct
This study will be carried out in the prenatal section of Al-Zahra Hospital in Rasht. 80 patients are randomly divided into two groups of control and intervention. If they have entry criteria after obtaining written informed consent, a demographic information, perceived stress questionnaire Will be completed in two groups. In the control group, no interventions will be performed by the researcher and patients will receive only routine care. In the intervention group, an intervention based on the understanding of the disease was performed individually in 3 sessions of 30 minutes Will be a booklet compiled by the researcher at the end of the second session Patients are offered. After the intervention, the perceived stress questionnaire will be completed in both groups.
Participants/Inclusion and exclusion criteria
Entry criteria: Having a willingness to participate in research, definite diagnosis of diabetes by routine screening tests during the 24th to 28th weeks of pregnancy, the ability to speak and understand Persian, lack of chronic disease other than gestational diabetes, no known and diagnosed mental illness According to self-declaration, there is no history of gestational diabetes in the previous pregnancy.
Exit criteria: Any maternal and fetal complications; Transfer to a treatment center during the study.
Intervention groups
In the control group, no intervention will be performed by the researcher and patients will only receive routine care. In the intervention group, an intervention based on an understanding of the disease will be performed individually in 3 sessions of 30 minutes. A booklet compiled by the researcher will be provided at the end of the second session to the patients.
Main outcome variables
Perceived Stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171103037191N1
Registration date:2018-02-17, 1396/11/28
Registration timing:registered_while_recruiting
Last update:2018-02-17, 1396/11/28
Update count:0
Registration date
2018-02-17, 1396/11/28
Registrant information
Name
Samaneh Khodaparast
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3351 9344
Email address
s.khodaparast@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-25, 1396/11/05
Expected recruitment end date
2018-04-25, 1397/02/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Illness Perception Educational Intervention on Perceived Stress of Women with Gestational Diabetics Rasht (2017)
Public title
The Effect of Increasing the understanding Of Gestational Diabetes Patients on Perceived Stress
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a Willingness to participate in the research
Definitive Diagnosis Of Diabetes by Routine Screening tests during the weeks 24 to 28 of pregnancy
The ability to Speak and understand persian
Lack of chronic disease other then Gestational Diabetes
lack of Recognized and recognized Psychological illness based on self_declaration
Not having of Gestational Diabetes during the pregnancy
Exclusion criteria:
Any complications of mother and fetus
Transfer to a treatment center during the study
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Random Block, Individual, Quadruple Blocking
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 Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences,Shahid Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Approval date
2017-11-22, 1396/09/01
Ethics committee reference number
IR.QUMS.REC.1396.327
Health conditions studied
1
Description of health condition studied
Gestational Diabetes
ICD-10 code
O24.41
ICD-10 code description
Gestational diabetes mellitus in pregnancy
Primary outcomes
1
Description
Perceived Stress
Timepoint
before and after intervention
Method of measurement
Cohen Perceived Stress scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention based on individual disease (face to face training) in 3 sessions of 30 minutes in 3 consecutive days in the morning shift. Session 1: At the first session, after initial communication with the patient and asking questions about his understanding of the current condition and its implications, the content will be presented. This session is based on five dimensions of understanding the illness and the impact of understanding the illness on psychological outcomes. These dimensions include the nature of the disease (on the adhesive and symptoms associated with the disease, such as fatigue, weakness); the cause of the onset of the disease; the duration or perception of the person during the illness; the outcomes and expected findings of the person from the disease; the effectiveness of control, treatment and improvement of the disease will be. To interfere with the understanding of the disease, self-control techniques, verbal encouragement, goal design (such as reducing dietary sugar), feedback and behavioral assessment, and the use of experiences from successful disease patients will be used. Session 2: After reviewing the session's training, the patient will be asked to talk about the emotions and ambiguities of her illness. The unique interventions will be adjusted according to the patient's need. Training will be designed to change the misconception and negative perception of the disease. Patients will be told if they have left a question beforehand, they can ask the researcher. At the end of the second session of the booklet, which includes identifying and defining the disease, what should be observed in your diet, physical activity and exercise, a brief explanation of the laboratory findings and psychological recommendations for reducing stress that the researcher will provide and Will be made available to the patient. Third Session (Evaluation and Closing): The session will be informed to the patient about this closing session. First, review the training of the previous sessions and then ask the patient about the effects of new training and experiences. Problems and barriers will be investigated for each patient.
Category
Prevention
2
Description
Control group: In this group, there will be no intervention by the researcher and patients will only receive routine care.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Samane khodaparast
Street address
opposite Shahid Azodi Stadium,Namjoo Street, Rasht town
City
Rasht
Province
Guilan
Postal code
41667-54567
Phone
+98 13 3336 9323
Fax
+98 13 3336 9024
Email
azzahra@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Peymani
Street address
Deputy Minister for Research and Technology, Qazvin University of Medical Sciences,Alley Mavaddat, Shahid Beheshti Blvd
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 7006
Fax
Email
apeymani@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Nasim Bahrami
Position
Associate َProfessor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Qazvin University of Medical Sciences,Shahid Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28333360015
Email
nbahrami@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohamad Ali soleimani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28333360015
Email
soleimany.msn@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Samaneh.Khodaparast
Position
Master's degree in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Unit 4, Floor 2, Building of Parsa ,Alley 38,Shahid Rajaee Blvd
City
Rasht
Province
Guilan
Postal code
41667-54567
Phone
+98 13 3351 9344
Email
samane.khodaparast77@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