Effect of life skills training on pregnancy anxiety in pregnant women over 30 years old
Design
The intervention group was 39 and in the non-intervention group was 39. With a 10% drop, there would be 43 in each group. (86 people in total).
Settings and conduct
Abadan health centers were randomly selected from 6 clinics. 3 clinics as intervention group and 3 clinics as control group. 180 questionnaires were given to pregnant women referred to these clinics. Of the total women, only 86 who received a pregnancy anxiety score of 280 - 160 from the Wendenberg Pregnancy Anxiety Scale were selected for the intervention group (43) - control (43)
Participants/Inclusion and exclusion criteria
Women over 30 years old; pregnant women after the first trimester; pregnancy anxiety diagnosis based on Wendenberg questionnaire with pregnancy anxiety score between 160 - 280; minimum literacy reading; willingness to participate in the project and having written consent; not receiving psychiatric treatment or other medication (at least one month before the study) for anxiety-related problems
Exclusion criteria: diagnosed cases of mental disorders; diagnosis of death of a loved one in the last 6 months; history of drug use affecting mental health
Intervention groups
Based on the inclusion criteria, the intervention group was divided into 5 groups, each consisting of 3 to 4 persons.
Life skills training sessions lasted 2 sessions per week and each session lasted 2 minutes. During these sessions, life skills were taught to pregnant women. The control group again completed the Vandenberg Pregnancy Anxiety Questionnaire after 6 weeks without any training.
Main outcome variables
Life skills training; pregnancy anxiety
General information
Reason for update
Acronym
LSTAP
IRCT registration information
IRCT registration number:IRCT20191001044945N1
Registration date:2020-06-02, 1399/03/13
Registration timing:retrospective
Last update:2020-06-02, 1399/03/13
Update count:0
Registration date
2020-06-02, 1399/03/13
Registrant information
Name
Fateme Hassanpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5335 2505
Email address
fatemehasanpoor50@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-13, 1398/01/24
Expected recruitment end date
2019-08-22, 1398/05/31
Actual recruitment start date
2019-04-21, 1398/02/01
Actual recruitment end date
2019-08-22, 1398/05/31
Trial completion date
2019-08-22, 1398/05/31
Scientific title
Effect of life skills training on pregnancy anxiety in pregnant women over 30 years old
Public title
The effect of life skills training on pregnancy anxiety
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women over 30 years old
Pregnant women after the first trimester
Diagnosis of pregnancy anxiety based on Wendenberg questionnaire with pregnancy anxiety score between 160-280
Minimum literacy
Willingness to participate in the study and obtain written consent
Not receiving psychotherapy or other medication concurrently (at least one month before the study) for anxiety-related problems
Exclusion criteria:
Diagnosed cases of mental disorders
Detection of a loved one's death in the last 6 months
A history of taking drugs that affect mental health
Age
From 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
43
Actual sample size reached:
43
Randomization (investigator's opinion)
Randomized
Randomization description
After receiving the code of ethics and obtaining a license from Ahvaz Jundishapur University of Medical Sciences, Abadan University of Medical Sciences, six clinics were randomly selected by submitting it to Abadan clinic centers and bases.
Pregnant women referred to 3 clinics as intervention group and 3 clinics as control group were included in the study.
These centers were selected from health centers of the three socio-economic zones of Abadan city, 2 centers from each district.
Thus, two centers were selected from the prosperous area, 2 medium and 2 low, and each center was assigned one intervention group and one control group.
The specimens were examined by referring to existing system files and then by telephone or in-person referral to clinics and the inclusion criteria were assessed.
Then, 180 questionnaires were given to pregnant women referring to these clinics, who were eligible for inclusion in the study, Wendenberg Pregnancy Anxiety Questionnaire.
The researcher received written informed consent in an individual interview with each pregnant mother after introducing herself and providing a fuller description of the aims and method of study of the participant with inclusion criteria and assurance of confidentiality.
After explaining how to complete the questionnaires, at the same place the questionnaire was completed by pregnant women and only 86 women out of all women who had received the Wendenberg Anxiety Inventory completed pregnancy anxiety scores between 280 and 160 for the intervention group (43). - Control (43) subjects were selected
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
University City, Ahvaz Jundishapur University of Medical Sciences and Health Services Vice Chancellor for Research and Technology, ground floor- zip code: 15794-61357
City
Abadan
Province
Khouzestan
Postal code
15794-61357
Approval date
2019-04-13, 1398/01/24
Ethics committee reference number
IR.AJUMS.REC.1398.026
Health conditions studied
1
Description of health condition studied
Pragnancy Anxity
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Pregnancy anxiety score based on Vendenberg Pregnancy Anxiety Questionnaire PRAQ
Timepoint
Before intervention
Method of measurement
Pregnancy Anxiety Score from 160 to 280 from Vendenberg Pregnancy Anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The present quasi-experimental study consists of three parts: pre-test, intervention and post-test. When the initial questionnaires were completed by pregnant women.Based on the inclusion criteria, the intervention group was divided into 5 groups, each consisting of 3 to 4 persons, and for each group, life skills training was conducted separately by the researcher in a face-to-face workshop. In the life skills training sessions, the researcher first obtained information through question and answer, group discussion, brainstorming from mothers' knowledge and attitudes about those topics, and then through lecture methods and PowerPoint presentations to better understand her topics. The session was offered to pregnant mothers, and each training session was organized as a workshop with the participation of pregnant women.It should be noted that in order to make the training more effective and effective, and taking into account the specific circumstances of the pregnant women during the week, virtual training was provided in the WhatsApp groups.These tutorials included relaxation exercise videos, reviewing the content of each session in the form of videos, photos and audio recorded by the researcher, PowerPoint Educational, which provided fun and enjoyable moments for mothers. Life skills training sessions lasted 2 sessions per week and each session lasted 2 minutes.Pregnant women were taught life skills (self awareness, problem solving skills, stress control, emotion control, communication skills, and interpersonal relationships).Then, in the sixth session, the Vandenberg Pregnancy Anxiety Questionnaire was completed by the intervention group.
Category
Behavior
2
Description
Control group: The control group completed Wendenberg Pregnancy Anxiety Questionnaires after 6 weeks without receiving any training and then ethically trained and given virtual training videos, relaxation exercise videos and songs for moral control. Calming and PowerPoint tutorials were provided in the form of a DVD.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
6 Abadan Health Center
Full name of responsible person
Fateme Hasanpoor
Street address
No 16, Dr. Mohammadi, Doctors' Home, 17 Shahrivar Hospital, Shoteite
City
Abadan
Province
Khouzestan
Postal code
6318913331
Phone
+98 61 5335 2505
Email
fatemehasanpoor50@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Majid Karandish
Street address
Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8395
Email
info@ajums.ac.ir
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
Mojgan Javad Noori
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Ahvaz University of Medical Sciences - School of Nursing and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8395
Email
mojganjavadnoori@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fateme Hassanpour
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
17th Shahrivar hospital
City
Abadan
Province
Khouzestan
Postal code
6318913331
Phone
+98 61 5335 2505
Fax
Email
fatemehasanpoor50@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fateme Hassanpour
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
17th Shahrivar hospital
City
Abadan
Province
Khouzestan
Postal code
6318913331
Phone
+98 61 5335 2505
Fax
Email
fatemehasanpoor50@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
Because of the confidentiality of the information
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
Not applicable
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