Effect of mindfulness-based group counseling versus control group on perceived stress in pregnant women with gestational diabetes: a double-blind randomized clinical trial
To assess the effect of mindfulness-based group counseling versus control group on perceived stress in pregnant women with gestational diabetes
Design
This is a randomized clinical trial with control group, in which eligible patients will be randomly assigned through the block randomization to the intervention and control groups
Settings and conduct
This study will be performed in the Diabetes Center of Besat Hospital in Hamadan city on 80 eligible pregnant women with gestational diabetes. The patients will be randomly assigned to the intervention and control groups through the block randomization. Blinding is not possible in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 16 to 45 years
Gestational age of 28 weeks and more
Gestational Diabetes
Having stress
Exclusion criteria:
History of mental illness
Occurrence of fetal complications
Intervention groups
Intervention group:
Routine care for diabetic patients, in addition to group counseling based on mindfulness, including 8 sessions of 60 to 90 minutes once a week (including the concept of mindfulness, automatic guidance system, facing obstacles, breathing meditation practice, sitting meditation practice, breathing space practice, body inspection awareness of breathing and body and sounds and thoughts, anxiety and its relationship with stress, awareness of pleasant and unpleasant events, self-care, conscious yoga, sleep hygiene, and preparing a list of enjoyable activities)
Control group:
Just routine care for diabetic patients
Main outcome variables
Primary outcome:
Perceived stress score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N440
Registration date:2022-09-09, 1401/06/18
Registration timing:prospective
Last update:2022-09-09, 1401/06/18
Update count:0
Registration date
2022-09-09, 1401/06/18
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of mindfulness-based group counseling versus control group on perceived stress in pregnant women with gestational diabetes: a double-blind randomized clinical trial
Public title
Effect of mindfulness-based group counseling versus control group on perceived stress in pregnant women with gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 16 to 45 years
Gestational age of 28 weeks and more
Gestational Diabetes
Having stress
Exclusion criteria:
History of mental illness
Occurrence of fetal complications
Age
From 16 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is 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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2022-08-20, 1401/05/29
Ethics committee reference number
IR.UMSHA.REC.1401.459
Health conditions studied
1
Description of health condition studied
Gestational diabetes mellitus
ICD-10 code
O24.4
ICD-10 code description
Gestational diabetes mellitus
Primary outcomes
1
Description
Perceived stress score
Timepoint
Before the intervention and 8 weeks later
Method of measurement
Using Cohen's Perceived Stress Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine care for diabetic patients, in addition to group counseling based on mindfulness, including 8 sessions of 60 to 90 minutes once a week (including the concept of mindfulness, automatic guidance system, facing obstacles, breathing meditation practice, sitting meditation practice, breathing space practice, body inspection awareness of breathing and body and sounds and thoughts, anxiety and its relationship with stress, awareness of pleasant and unpleasant events, self-care, conscious yoga, sleep hygiene, and preparing a list of enjoyable activities)
Category
Other
2
Description
Control group: Just routine care for diabetic patients
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Center of Besat Hospital in Hamadan city
Full name of responsible person
Niloofar Anajafi Marzijani
Street address
Diabetes Center of Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
niloofaranajafi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Niloofar Anajafi Marzijani
Position
Midwifery Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
niloofaranajafi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Zahra Masoomi
Position
Reproductive Health Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
zahramid2001@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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