Determining the effect of levantin's theory on illness perception of women with gestational diabetes
Design
A clinical trial was conducted in two parallel groups, which consisted of 80 women with gestational diabetes mellitus in the prenatal department of the hospital who were randomly assigned to control and intervention groups.
Settings and conduct
This study was conducted in the Pre-Nantal Department of Azzahra Hospital in Rasht. If the criteria for entering written consent were met, demographic questionnaire and perceived disease questionnaire were completed in both groups. In the control group, no intervention was performed by the researcher. In the experimental group, an intervention based on the illness perception was performed individually in 3 sessions of 60 to 90 minutes. A booklet was compiled by the researcher at the end of the third session to the patients in the experimental group and one month after the intervention in the control group. After intervention and one month after intervention, the illness perception questionnaire was completed again in both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having a desire to participate in research, Detection of diabetes by routine screening tests at weeks 24 to 28 of pregnancy, Ability to speak and understand Persian language, Not having chronic disease other than gestational diabetes, Not having a history of gestational diabetes
Exclusion criteria: Any complications in mother and fetus
Intervention groups
In the experimental group, intervention based on illness perception was performed individually in 3 sessions of 60-90 minutes. The booklet was compiled by the researcher and presented to the patients at the end of the third session. In the control group, no intervention was performed by the researcher and patients received only routine hospital care.
Main outcome variables
Illness perception
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171103037191N2
Registration date:2019-01-02, 1397/10/12
Registration timing:registered_while_recruiting
Last update:2019-01-02, 1397/10/12
Update count:0
Registration date
2019-01-02, 1397/10/12
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
2018-11-21, 1397/08/30
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of leventhal's self-regulatory theory on illness perception of women with gestational diabetes
Public title
The effect of leventhal's self-regulatory theory on illness perception of women with gestational diabetes
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 than gestational diabetes
Not having known and diagnosed mental illness based on self-declaration
Not having a history of gestational diabetes during the previous pregnancy
Exclusion criteria:
Any complications in mother and fetus
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
67
Randomization (investigator's opinion)
Randomized
Randomization description
In the first step, 80 samples were selected according to the Inclusion criteria. In the next step, these patients were assigned into two groups (intervention and control) by adopting 4-way blocking method. Each group consisted of 40 samples. By assigning cards to 6 blocks possible with numbers 1-6 and placed in the container, then by selecting 20 cards from 6 cards (block), the appropriation could be done as follows.The sequence was continued until sample 80 was reached.
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
2018-11-17, 1397/08/26
Ethics committee reference number
IR.QUMS.REC.1397.187
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
Illness perception
Timepoint
Before and After Intervention
Method of measurement
Illness perception Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention based on the illness perception individually (face to face training) will be performed in 3 sessions of 60-90 minutes in 3 consecutive days in the morning shift. In the first session, after the initial communication with the patient and asking questions about his illness perception and its consequences, the content will be presented. This session is based on five dimensions of illness perception and the impact of illness perception psychological outcomes. These dimensions include the nature of the disease (illness symptoms, such as fatigue, weakness); the cause of the onset of the disease; the duration or perception of the person during the illness; the outcomes of the person expected from the disease; the effectiveness of control, treatment and improvement of the disease. To interfere with the illness perception, 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.In the second session, after reviewing the sessions, 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. In the third session (evaluation and termination), the patient will be notified of the appointment before the end of the 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. At the end of the third session, an educational booklet containing of items such as: diagnosis and definition of the diseases, points that must be observed in the diet, exercising and playing sports and also a short explanation of the laboratory finding, prepared and planned by the researcher,is given to the patient.
Category
Prevention
2
Description
Control group: In the control group, no intervention was performed by the researcher and patients received only routine hospital care.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Al Zahra Hospital
Full name of responsible person
Samaneh Khodaparast
Street address
Azzahra Training Center,opposite Shahid Azodi Stadium,Namjoo Street,Rasht
City
Rasht
Province
Guilan
Postal code
41667-54567
Phone
+98 13 3336 3923
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
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 28 3333 6001
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
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 2833336001_5
Email
nbahrami@qums.ac.ir
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 1, Floor1, Building of Kamand, Alley 30,Farhangian Town, Jahad Square, Rasht
City
Rasht
Province
Guilan
Postal code
41667-54567
Phone
+98 13 3377 3510
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
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
Undecided - It is not yet known if there will be a plan to make this available