determination of the effectiveness of mindfulness-based counseling on anxiety in pregnant women with gestational diabetes
Design
This research is a clinical trial with pretest-post test design with control group and with parallel groups without blindness. The sample size is 88 people and will be divided into two groups of control and test according to the random numbers table
Settings and conduct
This study will be carried out on pregnant women with gestational diabetes referred to health centers in Kerman.To select samples from the available sampling method, they will be invited by telephone call. After obtaining the consent and justification of the participants about the goals of the study and its implementation, as well as ensuring the confidentiality of the results, the demographic and midwifery profile questionnaire and Spielberg Situational and Attribute Anxiety are completed.
Participants/Inclusion and exclusion criteria
The inclusion criteria consisted of Age of 18-45 years; Reading and writing literacy; Having score of Situational anxiety 20-53 and Attribute anxiety 20-56; Gestational age 24-28 weeks; Gestational diabetes mellitus. The exclusion criteria consisted of History of mindfulness training; Having diabetes before pregnancy; Exposure to major stress caused by unforeseen incidents (grief, divorce)
Intervention groups
The intervention group will receive 8 sessions of group counseling based on mindfulness. sessions are 120 minutes and once a week by researcher. The control group does not receive intervention. At the end of the session, all participants in the study will be given a book on the subject of mindfulness.
Main outcome variables
Mean score of anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180627040261N1
Registration date:2018-09-04, 1397/06/13
Registration timing:retrospective
Last update:2018-09-04, 1397/06/13
Update count:0
Registration date
2018-09-04, 1397/06/13
Registrant information
Name
Fatemeh Hamidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3312 4445
Email address
Hamidi.f@ajums.stu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the Effectiveness of Mindfulness-based Counseling on Anxiety in Pregnant Women with Gestational Diabetes
Public title
The Effect of Counseling on Anxiety in Pregnant Women with Gestational Diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18-45 years
Reading and writing literacy
Having score of Situational anxiety 20-53 and Attribute anxiety 20-56
Gestational age 24-28 weeks
Gestational diabetes mellitus
Exclusion criteria:
History of mindfulness training
Having diabetes before pregnancy
Exposure to major stress caused by unforeseen incidents (grief, divorce)
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals will be placed in one of the two intervention and control groups using simple randomization sequences based on random numbers
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 Ahvaz Jundishapur University of Medical Sciences
Street address
Deputy of Research and Technology Development, Jundishapur University of Medical Sciences, Ahwaz, Ground floor
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-03-06, 1396/12/15
Ethics committee reference number
IR.AJUMS.REC.1396.1088
Health conditions studied
1
Description of health condition studied
Gestational Diabetes
ICD-10 code
O24.4
ICD-10 code description
Gestational diabetes mellitus
Primary outcomes
1
Description
Anxiety
Timepoint
Before the intervention, immediately after the intervention and one month after the intervention
Method of measurement
Spielberger Situational and Attribute Anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group is divided into 4 groups of 11 people and each group will receive 8 sessions of group counseling based on mindfulness.The duration of each session is 120 minutes and once a week.
Category
Behavior
2
Description
Control group: No intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers in Kerman
Full name of responsible person
Fatemeh Hamidi
Street address
Health centers in Kerman
City
Kerman
Province
Kerman
Postal code
76169-13555
Phone
+98 34 3121 5600
Email
fatemeh.hamidi71@ymail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Deputy of Research, Ahwaz Jundishapur University of Medical Sciences
Street address
Ahvaz, Deputy of Research, Ahwaz Jundishapur University of Medical Sciences, Ground floor
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 3477
Email
fatemeh.hamidi71@ymail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Hamidi
Position
Master's student in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Golestan Blvd, Golestan Dormitory
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 34 3312 4445
Email
fatemeh.hamidi71@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mozhgan Javadnoori
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Jundishapur University
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8395
Email
mozhganjavadnoori@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Hamidi
Position
Master's student in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Golestan Blvd, Golestan Dormitory
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 34 3312 4445
Email
fatemeh.hamidi71@ymail.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
Undecided - It is not yet known if there will be 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