Determining the effectiveness of psychological immunization on the level of worry and anxiety
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 84 participants. Random blocking of 4 will be used for randomization
Settings and conduct
The location of the study will be the Diabetes Clinic of Tohid Hospital affiliated to Kurdistan University of Medical Sciences.For the intervention group, 6 sessions of psychological immunization training classes will be held, and for the control group, routine care will be done. Outcome assessors will mask to treatment allocation during the study
Participants/Inclusion and exclusion criteria
Inclusion criteria:
18–44 years old women; diagnosed with gestational diabetes based on expert opinion; able to read and write in Persian language; singleton pregnancy
absence of other diseases for high-risk pregnancies (pregnancy poisoning, abnormal bleeding, placenta Previa and etc. ..); absence of any history of using drugs, psychotropic substances, alcohol, cigarettes and tobacco; absence of any history of hospitalization in a psychiatric ward or taking related drugs
Absence of unfortunate events during the previous month; obtaining a score above the cut-off in one of psychological disorders ( worry, anxiety) , except for severe cases that require referral
Exclusion criteria :
unwillingness to continue the study; occurrence of any complication during pregnancy; Occurrence of major stressful events during the study (such as the death of a family member and divorce...)
Intervention groups
The intervention group includes women with gestational diabetes who will receive 6 sessions of psychological immunization training class. The control group consists of women with gestational diabetes who will receive routine care intervention.
Main outcome variables
anxiety, worry
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160821029446N12
Registration date:2023-03-14, 1401/12/23
Registration timing:registered_while_recruiting
Last update:2023-03-14, 1401/12/23
Update count:0
Registration date
2023-03-14, 1401/12/23
Registrant information
Name
Maryam Damghanian
Name of organization / entity
Nursing and Midwifery Faculty, Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
m-damghanian@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-05, 1401/12/14
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of psychological immunization on the level of worry and anxiety in women with Gestational diabetes mellitus
Public title
The effectiveness of psychological immunization on the level of worry and anxiety
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
pregnant women aged 18–44 years old
diagnosed with gestational diabetes based on expert opinion
able to read and write in Persian language
singleton pregnancy
absence of other diseases for high-risk pregnancies (pregnancy poisoning, abnormal bleeding, placenta Previa, early delivery and etc. ..)
absence of any history in using drugs, psychotropic substances, alcohol, cigarettes and tobacco
absence of any history of hospitalization in a psychiatric ward or taking related drugs
Absence of unfortunate events during the previous month
obtaining a score above the cut-off in one of psychological disorders ( worry, anxiety) , except for severe cases that require referral
Exclusion criteria:
unwillingness to participate in the study
absence in any of the training sessions
occurrence of any complication during pregnancy
Occurrence of major stressful events during the study (such as the death of a family member and divorce...)
Age
From 18 years old to 44 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
En Assignment of samples to intervention (A) and control (B) groups (42 people in each group) will be done using blocks with size of 4. In this way, 6 possible modes will be considered using a table of random numbers. These 6 modes are written on 6 separate cards and the cards will be placed in a black bag (for concealment) . A card will be issued for 21 times to finally get 84 letters written as the sample size. The intervention group will be the group that will receive psychological immunization training sessions in addition to childbirth preparation classes, and the control group will be the group that will receive only childbirth preparation classes.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a Randomized Controlled single-blind Trial, in which the statistical analyst is not aware of the type of intervention used for the two groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
School of Nursing & Midwifery, Tehran University of Medical Scienses, tohid sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733172
Approval date
2022-11-28, 1401/09/07
Ethics committee reference number
IR.TUMS.FNM.REC.1400.116
Health conditions studied
1
Description of health condition studied
level of worry
ICD-10 code
R45.82
ICD-10 code description
Worries
2
Description of health condition studied
anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
worry
Timepoint
before intervention and after the intervention
Method of measurement
worry score in Prenatal Distress questionnaire
2
Description
anxiety
Timepoint
before intervention and after the intervention
Method of measurement
anxiety score in pregnancy related anxiety questionnaire
Intervention group: For the people of the intervention group, the psychological immunization training class will be held in the form of 6 sessions of 90 minutes, two sessions per week. Psychological immunization sessions in the form of group interviews (in the form of talking in class), performing relaxation techniques, examining mothers' views and worries about diabetes, examining environmental and internal stressors and factors causing anxiety and worry in mothers, answering each These symptoms, teaching relaxation techniques, teaching coping techniques against stress, giving correct information to mothers, checking mothers' sense of sufficiency and teaching them the necessary points, expressing mothers' feelings and fears, etc. will be held.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
diabetes clinic of Sanandaj tohid hospital
Full name of responsible person
Leila Ghavami Garabad
Street address
School of Nursing & Midwifery, Tehran University of Medical sciences. Tohis sq, Tehram, Ian
City
Sanandaj
Province
Kurdistan
Postal code
1419733171
Phone
+98 21 6105 4222
Email
leila.ghavami1368@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Shahzad Pashipour
Street address
School of Nursing & Midwifery, Tehran University of Medical sciences. Tohis sq, Tehram, Ian
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
fnm@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Leila Ghavami Garabad
Position
دانشجوی ارشد مامایی
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing & Midwifery, tehran university of medical science, tohid sq, Twhran, Iran
City
Tehran
Province
Tehran
Postal code
1499733171
Phone
+98 21 6692 7171
Email
leila.ghavami1368@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Damghanian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing & Midwifery, Tehran University of Medical sciences, Tohid sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733172
Phone
+98 21 6105 4000
Email
maryam_damghanian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Damghanian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing & Midwifery, Tehran University of Medical Scienses, tohid sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733172
Phone
+98 21 6692 7171
Email
Maryam_Damghanian@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD