Comparative study of the effect of virtual and telephone self-care training methods based on health belief model on quality of life of primigravid women with preeclampsia in the postpartum period
Comparative study of the effect of virtual and telephone self-care training methods based on health belief model on quality of life of primigravid women with preeclampsia in the postpartum period
Design
This randomized clinical trial design is a parallel, non-blind design with a control group. This randomized study, phase 2-3 study will be performed on 75 nulliparous women. Random number table is used for randomization and participants are assigned to three groups (two intervention groups and one control group).
Settings and conduct
This study will be performed in Motazedi Hospital of Kermanshah. It is a non-blinded one. Before performing the interventions in the target groups, the needs assessment will be performed based on the health belief model, then the intervention design and the content of the educational program will be based on the health belief model.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women who have preeclampsia of different severity during pregnancy and childbirth (except eclampsia) based on preeclampsia criteria and clinical and paraclinical evidence approved by a gynecologist; Primiparous women with preeclampsia whose labor has resulted in the birth of a live baby.
Exclusion criteria: Different types of severe mental disorders that are under medical treatment or need hospitalization
Intervention groups
The first intervention group for 7 sessions of 30 to 60 minutes, one session per week using WhatsApp virtual messenger network will be under a training program based on the pattern of health belief. The second intervention group will undergo a training program based on the health belief model for 7 weeks (one phone call per week, the duration of phone calls is at least 30 and at most 60 minutes, and the time is between 9 am and 9 pm). The control group does not receive any intervention
Main outcome variables
Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N176
Registration date:2021-09-29, 1400/07/07
Registration timing:prospective
Last update:2021-09-29, 1400/07/07
Update count:0
Registration date
2021-09-29, 1400/07/07
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-07, 1400/07/15
Expected recruitment end date
2022-07-06, 1401/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of virtual and telephone self-care training methods based on health belief model on quality of life of primigravid women with preeclampsia in the postpartum period
Public title
A comparative study of the effect of virtual and telephone self-care training methods on the quality of life of nulliparous women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a mobile phone and internet access
Women who have preeclampsia of different severity during pregnancy and childbirth (except eclampsia) based on preeclampsia criteria and clinical and paraclinical evidence approved by a gynecologist
Primiparous women with preeclampsia whose labor has resulted in the birth of a live baby.
Exclusion criteria:
Different types of severe mental disorders (psychosis, schizophrenia, etc.) that are under medical treatment or need hospitalization
Age
From 15 years old to 49 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
The random assignment method is based on a table of random numbers and numbers between zero and 0.333 are in group one, from 0.334 to 0.666 in the second group and from 0.667 to 0.999 in the third group. Random assignment is done by someone who has no role in measuring the variables
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 Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2021-08-09, 1400/05/18
Ethics committee reference number
IR.KUMS.REC.1400.407
Health conditions studied
1
Description of health condition studied
preeclampsia
ICD-10 code
O14.9
ICD-10 code description
Unspecified pre-eclampsia
Primary outcomes
1
Description
Quality of Life
Timepoint
Before the intervention, 1 and 3 months after the intervention
Method of measurement
Based on Quality of Life Questionnaire (SF-36)
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group 1, for 7 sessions of 30 to 60 minutes, one session per week using WhatsApp virtual messenger network will be under a training program based on the pattern of health belief (text, video, poster, discussion, question and answer)
Category
Treatment - Other
2
Description
The intervention group 2, will undergo a training program based on the health belief model for 7 weeks (one phone call per week, the duration of phone calls is at least 30 and at most 60 minutes and the time is between 9 am and 9 pm).
Category
Treatment - Other
3
Description
The control group will receive routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Motazedi Hospital
Full name of responsible person
Zahra Hosseini Shoar
Street address
Motazedi Hospital, Ferdowsi Square
City
Kermanshah
Province
Kermanshah
Postal code
67188 14474
Phone
+98 83 3724 6351
Email
zahrahoseini7620@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Reza Khodarahmi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
rkhodarahmi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Zahra Hosseini Shoar
Position
Master student of counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
zahrahoseini7620@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mastaneh KamervaManesh
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
kamravamanesh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Zahra Hosseini Shoar
Position
Master student of counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
zahrahoseini7620@gmail.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