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The effect of multimedia educational intervention based on health promotion model on doing relaxation and anxiety among primigravida women

Protocol summary

Study aim
Determining the effect of a multimedia educational intervention based on health promotion model on performing relaxation and anxiety among primigravida women in Busher
Design
A quasi-experimental study، two groups of intervention and control, multi-stage sampling, parallel groups, sample size of 84, Primigravida women, phase I
Settings and conduct
This study will be conducted in comprehensive Health Care Center in Bushehr. Five centers will be selected as control and 5 as the intervention groups. The blinding is not possible, but in order to prevent selection bias, the centers selected as intervention and control groups are separated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: First pregnancy experience, Gestational age of 28 to 32 weeks, Having an anxiety score higher than the median, Not having a history of mental illness, Not using anti-anxiety drugs, Having read and writing skills, Having a computer or device that can play video from a flash drive, The desire to participate in the study. Non-entry criteria: Unwilling to participate in the study
Intervention groups
The educational package will be designed after the development of educational content based on the health promotion model structures for the intervention group in the form of multimedia, Which will be available to participants through flash memory. For participants in the intervention group, weekly 2 text message reminders will be sent by SMS from the interval between the completion of the training program to one month later. There is no intervention for women in the control group and their anxiety levels are measured as the intervention group. Before intervention and then two weeks and one month after the intervention, the questionnaires will be completed by the intervention and control groups
Main outcome variables
Awareness؛ perceived benefits؛ perceived barriers؛ perceived self-efficacy؛ perceived social support

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180529039898N1
Registration date: 2018-07-27, 1397/05/05
Registration timing: registered_while_recruiting

Last update: 2018-07-27, 1397/05/05
Update count: 0
Registration date
2018-07-27, 1397/05/05
Registrant information
Name
Zeinab Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3222 4511
Email address
mohammadi.z@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-11, 1397/04/20
Expected recruitment end date
2018-10-12, 1397/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of multimedia educational intervention based on health promotion model on doing relaxation and anxiety among primigravida women
Public title
The effect of multimedia educational intervention on doing relaxation and anxiety
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
First pregnancy experience Gestational age (28 to 32 weeks based on the exact date of the first day of the last menstruation) Having an anxiety score higher than the median score No history of mental illness (such as depression, schizophrenia, etc.) according to the electronic record Not taking anti-anxiety drugs based on electronic records Having reading and writing skills Having a computer or device that can play video from a flash drive The desire to participate in the study
Exclusion criteria:
Unwilling to participate in the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
we use simple random sampling for selecting comprehensive healthcare centers. Then, 5 centers will be randomly selected as the control groups and 5 as the interventions groups. In the next step, based on the records in the SIB (Integrated Health System) system, individuals with inclusion criteria will be selected according to the sample size of the study.
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 Busher University of Medical Sciences
Street address
Busher University of Medical Sciences, Salman farsi street, Risher
City
Busher
Province
Boushehr
Postal code
7518759577
Approval date
2018-03-12, 1396/12/21
Ethics committee reference number
IR.BPUMS.REC.1396.217

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder

Primary outcomes

1

Description
Anxiety Scale in Pregnancy Anxiety Questionnaire
Timepoint
Before the Intervention, Two Weeks and One Month After the Intervention
Method of measurement
Pregnancy Anxiety Questionnaire

Secondary outcomes

1

Description
Awareness
Timepoint
Before the Intervention, Two Weeks and One Month After the Intervention
Method of measurement
Awareness Questionnaire(Researcher made)

2

Description
Perceived Barriers
Timepoint
Before the Intervention, Two Weeks and One Month After the Intervention
Method of measurement
Perceived Barriers Questionnaire(Researcher made)

3

Description
Perceived Benefits
Timepoint
Before the Intervention, Two Weeks and One Month After the Intervention
Method of measurement
Perceived Benefits Questionnaire(Researcher made)

4

Description
Perceived Self-Efficacy
Timepoint
Before the Intervention, Two Weeks and One Month After the Intervention
Method of measurement
Perceived Self-Efficacy Questionnaire(Researcher made)

5

Description
Perceived Social Support
Timepoint
Before the Intervention, Two Weeks and One Month After the Intervention
Method of measurement
Perceived Social Support Questionnaire (Researcher made)

Intervention groups

1

Description
Intervention group: The educational package will be designed after the development of educational content based on the health promotion model structures in the form of multimedia, including text, graphics, audio and videos, which will be available to participants through flash memory. Participants in the intervention group have one week time to view the received educational content. In order to ensure that the educational content is viewed, they will be contacted after a week and questions about the educational content will be asked. Those who have not seen the content of the training at the specified time will be given three days added time. Finally, people who do not see educational content during this period will be excluded from the study. Also, a reminder text message (SMS) will be sent twice a week during one month (from the completion of the training program to one month later).
Category
Lifestyle

2

Description
Control group: Pregnant women in the control group will not receive any intervention. Before intervention and then two weeks and one month after the intervention, the questionnaires will be completed by the control group. After doing the final measurement, the educational content is given to the participants in the control group.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Kheybar Health Services Center
Full name of responsible person
Nasrin Shabankareh
Street address
Kheybar alley, Ashoori street
City
Busher
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3355 4687
Email
n.shababkareh@gmail.com

2

Recruitment center
Name of recruitment center
Hafte tir Health Services Center
Full name of responsible person
Zeinab Sarkhosh
Street address
Koosha special school alley, Imam Street
City
Busher
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3332 2286
Email
sarkhosh.z@gmail.com

3

Recruitment center
Name of recruitment center
Nabi akram Health Services Center
Full name of responsible person
Maryam Mohammadi
Street address
Bazargani Alley, Motahhari street
City
Busher
Province
Boushehr
Postal code
7718759577
Phone
+98 77 3355 4686
Email
mohammadi.m@gmail.com

4

Recruitment center
Name of recruitment center
Meraj Health Services Center
Full name of responsible person
Azarossadat Tabarestani
Street address
Shahid Hendizadeh alley ,Ashoori street
City
Busher
Province
Boushehr
Postal code
7516738846
Phone
+98 77 3355 4685
Email
azar.tabarestani@gmail.com

5

Recruitment center
Name of recruitment center
Ghods Health Services Center
Full name of responsible person
Leyla Savamery
Street address
32 Mehr Alley, Sabzabad street
City
Busher
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3352 5406
Email
leyla.savamery@gmail.com

6

Recruitment center
Name of recruitment center
Sahebzaman Health Services Center
Full name of responsible person
Rahimeh Jalilvand
Street address
In front of Shipping, Solh Abad Street
City
Busher
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3333 1420
Email
jalilvand.r@gmail.com

7

Recruitment center
Name of recruitment center
Shohada Health Services Center
Full name of responsible person
Zahra Hojabri
Street address
In front of cemetery, Behesht Sadegh Street
City
Busher
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3334 0547
Email
Hojabri.a@gmail.com

8

Recruitment center
Name of recruitment center
Shahid Beheshti Health Services Center
Full name of responsible person
Katayon Alibashi
Street address
Khajehha street
City
Busher
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3334 0547
Email
Alibashi.k@gmail.com

9

Recruitment center
Name of recruitment center
Hazrat Zeinab Health Services Center
Full name of responsible person
Farzane Agha
Street address
Eatemadiyeh street, Davas
City
Busher
Province
Boushehr
Postal code
7516875696
Phone
+98 77 3344 0805
Email
f.agha@gmail.com

10

Recruitment center
Name of recruitment center
Ali Ebne Abitaleb Health Services Center
Full name of responsible person
Soodabeh Zalpour
Street address
In front of the Sheikh Saadoun mosque, Kooti street
City
Busher
Province
Boushehr
Postal code
7513665958
Phone
+98 77 3332 5857
Email
soodabeh.zalpour@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Gholam Reza khamisipour
Street address
University of medical sciences, Salman farsi street, Risher
City
Busher
Province
Boushehr
Postal code
7518759577
Email
khamisipoor@Bpums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Mahnoosh Reisi
Position
Ph.D in Health Education and Health Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Busher University of Medical Sciences, Salman farsi street, Risher
City
Busher
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3332 2081
Email
reisi_mr@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Mahnoosh Reisi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Busher University of Medical Sciences, Salman farsi street, Risher
City
Busher
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3332 2081
Email
reisi_mr@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Zeinab Mohammadi
Position
Master Student Health education
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Busher University of Medical Sciences, Salman farsi street, Risher
City
Busher
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3332 2081
Email
z.moh7728@gmail.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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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