Effect of cognitive-behavioral approach versus control group on sleep status and blood sugar levels in women with gestational diabetes: a randomized clinical trial
To assess the effect of cognitive-behavioral approach versus control group on sleep status and blood sugar levels in women with gestational diabetes
Design
This is a Phase III randomized clinical trial with a control group with parallel groups without blinding, in which eligible patients will be randomly assigned to the intervention and control groups using block randomization.
Settings and conduct
This study will be conducted at the Comprehensive Health Centers in Arak city, involving 80 eligible patients with gestational diabetes. The patients will be randomly assigned to the intervention and control groups through the block randomization. However, it should be noted that blinding is not feasible in this trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 45 years;
Gestational diabetes;
Gestational age 24 to 28 weeks;
Singleton pregnancy;
Exclusion criteria:
Psychological disorders;
Use of tobacco, drugs or alcohol;
Taking sleeping pills;
Taking hypoglycemic drugs
Intervention groups
Intervention group:
Routine treatment of gestational diabetes in addition to cognitive-behavioral counseling for 30 to 40 minutes once a week for 6 weeks (including a complete assessment of the nature of insomnia, training on how to prepare a sleep report table, introducing the insomnia behavior regime, calculating the time allowed to stay in bed, sleep hygiene education, how to record thoughts related to insomnia, examination of common cognitive errors in people with insomnia, advice on the time allowed to stay in bed)
Control group:
Just routine treatment of gestational diabetes
Main outcome variables
Primary outcome:
Blood sugar levels; sleep status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N517
Registration date:2024-06-20, 1403/03/31
Registration timing:prospective
Last update:2024-06-20, 1403/03/31
Update count:0
Registration date
2024-06-20, 1403/03/31
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
2024-08-05, 1403/05/15
Expected recruitment end date
2025-03-05, 1403/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of cognitive-behavioral approach versus control group on sleep status and blood sugar levels in women with gestational diabetes: a randomized clinical trial
Public title
Effect of cognitive-behavioral approach versus control group on sleep status and blood sugar levels in women with gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 45 years;
Gestational diabetes;
Gestational age 24 to 28 weeks;
Singleton pregnancy;
Exclusion criteria:
Psychological disorders;
Use of tobacco, drugs or alcohol;
Taking sleeping pills;
Taking hypoglycemic drugs
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random assignment of patients to the intervention and control groups will be carried out using block randomization. To achieve this, four sheets of paper will be prepared - two with the name of the intervention and two with the name of the control. These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired 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 Arak University of Medical Sciences
Street address
Arak
City
Vice-chancellor for Research and Technology, Arak University of Medical Sciences, Sardasht Ave.
Province
Markazi
Postal code
3848176941
Approval date
2024-06-11, 1403/03/22
Ethics committee reference number
IR.ARAKMU.REC.1403.093 1403-03-22
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
Blood sugar levels
Timepoint
Before the intervention and 6 weeks later
Method of measurement
By taking a blood sample
2
Description
Sleep status
Timepoint
before the intervention and 6 weeks later
Method of measurement
Using the Pittsburgh Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment of gestational diabetes in addition to cognitive-behavioral counseling for 30 to 40 minutes once a week for 6 weeks (including a complete assessment of the nature of insomnia, training on how to prepare a sleep report table, introducing the insomnia behavior regime, calculating the time allowed to stay in bed, sleep hygiene education, how to record thoughts related to insomnia, examination of common cognitive errors in people with insomnia, advice on the time allowed to stay in bed)
Category
Treatment - Other
2
Description
Control group: Just routine treatment of gestational diabetes
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Health Centers in Arak city
Full name of responsible person
Sahar Pazooki
Street address
School of Medicine, Arak University of Medical Sciences, Sardasht Ave.
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 4135 7965
Email
pzksahar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Davood Hekmatpoor
Street address
Vice-chancellor for Research and Technology, Arak University of Medical Sciences, Sardasht Ave
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 4135 7965
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Sahar Pazooki
Position
Midwifery Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Medicine, Arak University of Medical Sciences, Sardasht Ave.
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 4135 7965
Email
pzksahar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Katayoon Vakilian
Position
Reproductive Health Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Medicine, Arak University of Medical Sciences, Sardasht Ave.
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 4135 7965
Email
cattyv2002@yahoo.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, 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