Effectiveness of online positive psychology counseling on psychological well-being of nulliparous pregnant women participant in childbirth preparation classes
Effectiveness of online positive psychology counseling on psychological well-being of nulliparous pregnant women participant in childbirth preparation classes
Design
The study is a two arm parallel group randomized trial without blinding on 74 eligible nulliparous pregnant women . convenience sampling method and Random Allocation software is used for randomization.
Settings and conduct
Research population: pregnant women referring to comprehensive health centers in Farsan city. Positive psychology intervention is conducted online by the second researcher, under the supervision of the first, third and fifth researchers. Childbirth preparation classes are held routinely in health centers.
Participants/Inclusion and exclusion criteria
Inclusion:
Iranian nationality.
Age 18 - 40 years.
Nulliparity.
Gestational Age 16 - 24 Week.
Single fetus.
Literacy for reading and writing.
Interested in participate in childbirth preparation classes.
Having Smartphone with licensed virtual software.
Internet access.
Voluntary willingness to participate in research.
Exclusion:
History of infertility.
High risk pregnancy( hypertension, vaginal bleeding, diabetes, thyroid disorders, placenta previa, fetal anomalies and...)
The occurrence of unfortunate events in the past six months, such as the death of loved ones, accidents, divorce and...
Self-reported drug abuse by the pregnant woman or her husband.
Having a history or being treated for psychiatric disorders.
Intervention groups
The control group participates in 8 weekly sessions of face-to-face childbirth preparation classes at health centers. In addition to the above class, the intervention group also participates in 8 weekly online positive counseling sessions.
Main outcome variables
Mean score of psychological well- being
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230212057395N1
Registration date:2023-03-18, 1401/12/27
Registration timing:prospective
Last update:2023-03-18, 1401/12/27
Update count:0
Registration date
2023-03-18, 1401/12/27
Registrant information
Name
Seyedehbatoul Hashemibabaheidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3324 7726
Email address
sb.hashemibabaheidari@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-09, 1402/01/20
Expected recruitment end date
2023-08-11, 1402/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of online positive psychology counseling on psychological well-being of nulliparous pregnant women participant in childbirth preparation classes
Public title
Effectiveness of online positive psychology counseling on psychological well-being of nulliparous pregnant women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian nationality
Age 18 - 40 years
Nulliparity
Gestational Age 16 - 24 week
Single fetus
Literacy for reading and writing.
Interested in participate in childbirth preparation classes
Having Smartphone with licensed virtual software
Internet access
Voluntary willingness to participate in research
Exclusion criteria:
History of infertility
High risk pregnancy( hypertension, vaginal bleeding, diabetes, thyroid disorders, placenta previa, fetal anomalies and...)
The occurrence of unfortunate events in the past six months, such as the death of loved ones, accidents, divorce and ...
Self-reported drug abuse by the pregnant woman or her husband
Having a history or being treated for psychiatric disorders
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
74 nulliparous pregnant women are selected based on the entry and exit criteria as convenience sampling method from the comprehensive health centers of Farsan city and the covered bases. Then they are divided into two groups of 37 people, positive counseling + childbirth preparation training (intervention group) and childbirth preparation training alone (control group) by a biostatistics specialist using simple randomization method and random number sequence with online randomization software ( using the site www.random.org/sequences).
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 Shahid Sadoughi University of Medical Sciences
Street address
Bahonar Square, Yazd
City
Yazd
Province
Yazd
Postal code
8916189165
Approval date
2023-03-01, 1401/12/10
Ethics committee reference number
IR.SSU.REC.1401.106
Health conditions studied
1
Description of health condition studied
Psychological well- being
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Measurement of mean score of psychological well- being in two groups
Timepoint
Measurement of the well-being variable at the beginning of the study (before the start of the intervention) and the eighth week (end of the intervention) and the twelfth week (follow-up) from the start of the study in two groups
Method of measurement
Ryff's Scales of Psychological Well-being
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Pregnant women in this group participate in 8 weekly 90-minute sessions of routine birth preparation classes, which are held face-to-face in groups of 8 to 10 people. These classes are conducted by trained midwives in health centers according to the protocol of the Ministry of Health. The contents of the sessions include anatomy of the reproductive system, nutrition during pregnancy, mental health of pregnant women, danger signs in pregnancy, benefits of natural childbirth, non-pharmacological pain relief methods, stages of labor, postpartum care and newborn health care. In addition, exercises to strengthen the skeletal-muscular system, breathing exercises and relaxation methods are taught that mothers should practice at home. At the beginning of each session; mothers should report how much they did their homework in the previous week.
Category
Behavior
2
Description
Intervention group: Pregnant women in this group, like the control group, participates in 8 weekly 90-minute sessions of face-to-face childbirth preparation classes that are established in health centers according to the protocol of the Ministry of Health. In addition, they also participate in online positive psychology training classes in groups of 12 to 15 people according to Seligman and Rashid's protocol in 8 weekly sessions of 90 minutes. These classes are conducted under the supervision of a psychologist consultant and by a senior student of counseling in midwifery who has completed the above course The content of the sessions includes explaining positive psychology, identifying strengths, expressing the role of positive feelings and emotions in increasing well-being, gratitude and forgiveness, focusing on the topic of hope and optimism, positive relationships, fascination and meaning in life. Each session has home practices, mothers are asked to do their practice before the next session and report the amount of practice in a virtual way in private.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Farsan health centers
Full name of responsible person
Azam Khoshbin
Street address
Bouali Ave
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1754
Email
azamkhoshbin@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi Abargouei
Street address
Alam Square, Medical Sciences Campus, Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3149 2229
Fax
Email
abargouei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Azam Khoshbin
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Bouali Ave
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1754
Email
azamkhoshbin@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Azam Khoshbin
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Bouali Ave
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1754
Email
azamkhoshbin@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Azam Khoshbin
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Bouali Ave
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1754
Email
azamkhoshbin@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All personal data of study participants can be shared after unidentifying.
When the data will become available and for how long
After results publication.
To whom data/document is available
The data will be available to researchers working in academia and academia, and people in the industry can apply for it.
Under which criteria data/document could be used
Scientific usage.
From where data/document is obtainable
azamkhoshbin@gmail.com
What processes are involved for a request to access data/document