Examination of the effect of protection motivation theory-based intervention on pregnant women's knowledge and self-protection regarding COVID-19.
Design
Randomized controlled trial- pre-post control group educational intervention- 163 participants will be followed for two months- Random assignment of participants will be conducted using randomization block technique- The study will be conducted from the beginning of August 2021 to February 2022
Settings and conduct
This study will be conducted at the Obstetrics and Gynaecology outpatient clinic at El Shatby Hospital, Alexandria governorate /Egypt.
Participants/Inclusion and exclusion criteria
Inclusion criteria: pregnant women in the first trimester, no visual or auditory problems, no psychological or mental disorders, willingness to participate in the study.
Intervention groups
The intervention group (G1): protection motivation theory-based intervention.
The control group (G2): routine outpatient teaching.
Main outcome variables
knowledge, and self-protection regarding COVID-19.
General information
Reason for update
Acronym
COVID-PMT
IRCT registration information
IRCT registration number:IRCT20210612051555N1
Registration date:2021-07-07, 1400/04/16
Registration timing:prospective
Last update:2021-07-07, 1400/04/16
Update count:0
Registration date
2021-07-07, 1400/04/16
Registrant information
Name
Samiha Hamdi
Name of organization / entity
Dmanhour University, Faculty of Nursing
Country
Egypt
Phone
+20 45 3538264
Email address
samihareda93@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-01, 1400/05/10
Expected recruitment end date
2022-02-01, 1400/11/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
COVID-19 Knowledge and Self-protection among Pregnant Women: Application of Protection Motivation Theory-based Intervention.
Public title
COVID-19 Knowledge and Self-protection among Pregnant Women: Application of Protection Motivation Theory-based Intervention.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women in the first trimester
Willingness to participate in the study
Exclusion criteria:
Visual or auditory problems
Psychological or mental 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:
170
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be randomly assigned to the intervention or control group through the randomization block technique. Six steps will be followed to carry out participants' assignments using the randomization block technique. First, the investigators will write a list contains numbers from 1 to 170. Second, the investigators will prepare small pieces of paper that comprise numbers from 1 to 170. Third; the investigators will fold each piece of paper to hide the written number, then it will be collected in a large bowl. Fourth; the researchers will divide the 170 pieces of paper into 17 blocks in a random and blind manner. Each block contains 10. Fifth; from each block, five pieces of papers will be selected randomly and blindly to the intervention group and the remaining 5 pieces of papers assigned to the control group. A total of 85 numbers will be assigned to each group. Sixth; the classification of cases will be recorded in the pre-prepared list (the word intervention or control will be recorded in front of each number) to be considered at the time of data collection.
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
Alexandria University, Faculty of nursing Ethical Committee
Street address
Izbat Saed, Sidi Gaber
City
Alexandria
Postal code
21523
Approval date
2021-01-07, 1399/10/18
Ethics committee reference number
06-07-01-2021 EC
Health conditions studied
1
Description of health condition studied
Corona virus
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Covid-19 Knowledge
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Self-report knowledge questionnaire
2
Description
Covid-19 self protection
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Self protection scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group: (The PMT-based education will be conducted in four sequential phases) Needs assessment: A pre-test will be done to evaluate the participants' knowledge and self-protection elements regarding COVID-19 based on PMT constructs. The goal of the needs assessment phase is to address deficiencies in the participants' knowledge and self-protection elements regarding COVID-19 during pregnancy in order to be considered during the educational intervention construction. In addition, the need assessment data will be used for comparison with the post-test. Planning: Based on the results obtained from the needs assessment, an educational intervention based on PMT constructs will be designed after reviewing the related current literature. The intervention encompasses four sessions. The first session concerned with COVID-19 definition, causative agent, mode of transmission, signs, and symptoms, high-risk group (perceived vulnerability), expected complications (perceived severity). The second session targeted the physiological changes during pregnancy and how it can increase the risk for COVID-19 complication (fear). in addition, special emphases will be done on infection control precautions and immunity enhancement methods. (response efficacy). The third session will discuss the COVID-19 vaccine including its benefits versus risk. (response cost) by correcting any misinformation about COVID-19 preventive practice (intrinsic reward). The aim of this session will be to foster positive attitudes and beliefs among pregnant women about COVID-19 preventive practices. The fourth session will aim to foster self-efficacy and self-protection intention regarding COVID-19. Furthermore, more times will be allowed to address each women's special needs and answering questions. PowerPoint presentations, printed booklets, and audiovisual aids will be available for use during the intervention. Implementation: The educational sessions will be done in the outpatient department with the help of the nursing staff. The educational session will be conducted to 3 to 4 women each time considering social distancing and application of infection control percussions. The teaching strategies will include lectures, video shows. group discussion, and brainstorming. Each session will continue for 30 to 45 minutes. A summary of the content will be provided at the end of each session and at the beginning of the second session. A sample of the protective equipment will be provided to each woman to help in the practical application. Copious printed educational materials will be given to motivate knowledge preservation and help concepts strengthening to support desired changes. Gloving and other infection control percussions will be followed during the distribution of the printed materials and protective equipment. The researchers will access the participants through mobile phones to arrange for the sessions. Evaluation: The post-test will be conducted two months after the intervention to evaluate the pregnant women's knowledge and protection motivation regarding COVID-19. A telephone interview will be used to complete the posttest if the women cannot come to the antenatal clinic.
Category
Prevention
2
Description
Control group: For the control group: A pre-test will be done in the outpatient clinic, then they left for routine hospital care and education. Two months later, reevaluation will be done using the same pretest tools. After completing the study, the educational presentation and the printed materials made available for the control group to maximize the benefits.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
the Obstetrics and Gynaecology outpatient clinic at El Shatby Hospital, Alexandria governorate /Egyp
Full name of responsible person
Samiha Hamdi Sayed Ramadan
Street address
Port Said Street, Alexandria
City
Alexandria
Postal code
21526
Phone
+20 45 3538264
Fax
+20 45 3538264
Email
Nursing.Alex@alu.nu.edu.eg
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Alexandria University, Faculty of Nursing
Full name of responsible person
Samiha Hamdi Sayed Ramadan
Street address
Izbat Saed, Sidi Gaber
City
Alexandria
Postal code
21523
Phone
+20 45 3538264
Email
samihareda93@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alexandria University, Faculty of Nursing
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
Damanhour University, Fcaulty of Nursing
Full name of responsible person
Samiha Hamdi Sayed Ramadan
Position
Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Damanhour, Elbehira, Governorate, Egypt
City
Damahour
Province
Damanhour
Postal code
22511
Phone
+20 45 3538264
Email
samihareda93@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Damanhour University
Full name of responsible person
Samiha Hamdi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Damanhour, Elbehira, Governorate, Egypt
City
Damahour
Province
Damanhour
Postal code
22511
Phone
+20 45 3538264
Email
samihareda93@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Damanhour University, Faculty of Nursing
Full name of responsible person
Samiha Hamdi Sayed Ramadan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Damanhour, Elbehira, Governorate, Egypt
City
Damahour
Province
Elbehira
Postal code
21523
Phone
+20 45 3538264
Email
samihareda93@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
Published research report that contains all the findings of the study.
When the data will become available and for how long
within one year and will be available long life
To whom data/document is available
for public
Under which criteria data/document could be used
for scientific use and public education
From where data/document is obtainable
none
What processes are involved for a request to access data/document