The Effect of Reality therapy on the Level of Anxiety, Stress, Depression and Cortisol in Pregnant Mothers in anticipation of Amniocentesis in Isfahan ،2019
The main objective
Determining the Effect of Health Reality on the Level of Anxiety, Stress,
Depression and Cortisol in Pregnant Mothers in anticipation of Amniocentesis in Isfahan City in 1398
Design
Clinical trial with intervention and control group, one blinded, with a sample size of 39 available for separation on a couple of days.
Settings and conduct
The observer community is the mothers who are referring to the genetic laboratories of the city of Isfahan for delivery of amniocentesis samples. The sampling method will be available. A DASS questionnaire 21 and demographic information and blood cortisol blood tests will be used to collect information.
Participants/Inclusion and exclusion criteria
Criteria for entering the study: age between 15-9 years, lack of underlying diseases, Nervous،Psychological and substance abuse, readiness or eligibility to participate in the study.
Exit criteria:. Absenteeism of each counseling session, non-attendance of instructions and training during the sessions, participants' reluctance to attend training sessions, incidental or unexpected events in each stage of the program, acute psychiatric illness
Intervention groups
A group for which real-therapeutic counseling is provided
Main outcome variables
Stress, Anxiety, Depression, Cortisol
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190423043351N1
Registration date:2019-08-09, 1398/05/18
Registration timing:registered_while_recruiting
Last update:2019-08-09, 1398/05/18
Update count:0
Registration date
2019-08-09, 1398/05/18
Registrant information
Name
maryam ghaderi najaf abadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3627 7989
Email address
m_ghadere@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Reality therapy on the Level of Anxiety, Stress, Depression and Cortisol in Pregnant Mothers in anticipation of Amniocentesis in Isfahan ،2019
Public title
The Effect of Reality therapy on the Level of Anxiety, Stress, Depression and Cortisol in Pregnant Mothers in anticipation of Amniocentesis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 49-15 years
Pregnancy
Carry out an amniocentesis test
Readiness and satisfaction to participate in the study
Exclusion criteria:
Underlying diseases
Neurological and neurological diseases
Drug abuse
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
People in both intervention and control groups are not aware of their group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman University of Medical Sciences
Street address
Haftbagh
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2019-04-10, 1398/01/21
Ethics committee reference number
IR.KMU.REC.1398.020
Health conditions studied
1
Description of health condition studied
Stress
ICD-10 code
F43.0
ICD-10 code description
Acute stress reaction
2
Description of health condition studied
ICD-10 code
ICD-10 code description
3
Description of health condition studied
ICD-10 code
ICD-10 code description
4
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
5
Description of health condition studied
Depression
ICD-10 code
P91.4
ICD-10 code description
Neonatal cerebral depression
Primary outcomes
1
Description
Score stress Stress score in DOS 21questionnaire
Timepoint
First and last meeting
Method of measurement
DOS 21 questionnaire
2
Description
Anxiety score in the DOS21 questionnaire
Timepoint
First and last meeting
Method of measurement
DOS21 questionnaire
3
Description
DOS21 questionnaire
Timepoint
First and last meeting
Method of measurement
DOS21 questionnaire
4
Description
Blood cortisol levels
Timepoint
First and last meeting
Method of measurement
blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Individuals in groups of 2 to 10 will participate in reality therapy counseling sessions, which consist of 4 sessions, which will last 90 to 120 minutes. In the first session, each individual will complete a DOS 21 questionnaire and 5 cc of blood. The cortisol test is performed and this process is repeated in the last session.
Category
Other
2
Description
Control group: People complete the questionnaire in the first session and do a blood test to measure blood cortisol levels. This process is repeated after one week and then a counseling session is performed.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Genazma Genetic Lab
Full name of responsible person
Majid Kheirolahi
Street address
No.208،West Shariati Street
City
Esfahan
Province
Isfehan
Postal code
8173958351
Phone
+98 31 3626 9587
Fax
+98 31 3626 3938
Email
mkheirollahi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abas Pardakhty
Street address
Haftbagh
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3855
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Maryam Ghaderi NajafAbadi
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Tavakoli,Roodaki,Vahid
City
Esfahan
Province
Isfehan
Postal code
8176848691
Phone
+98 31 3627 7989
Email
m_ghadere@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Firooze Mirzaee
Position
Assistant Professor in Reproductive Health. Department of Midwifery
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Haftbagh
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
f_mirzaee@Kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
MaryamGaderi NajafAbadi
Position
student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Tavakoli,Roodaki,Vahid
City
Esfahan
Province
Isfehan
Postal code
8176848691
Phone
+98 31 3627 7989
Email
m_ghadere@yahoo.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