Evaluation of the effect of educational intervention with mobile health technology and based on the theory of planned behavior on sleep quality, anxiety and perceived stress caused by the Covid-19 pandemic in pregnant women referred to urban health centers.
- Determining the demographic characteristics of the people under study
Determining the mean sleep quality score of pregnant women in the intervention group before, immediately and 1 month after the TPB-based educational intervention.
Design
Clinical trial with control group, with parallel groups, without blinding, random allocation using blocking, on 80 samples
Settings and conduct
Educational intervention in the form of 5 30-minute sessions in the intervention group in Gonabad city. Meetings will be held virtually with mobile health technology for both control and intervention groups in WhatsApp. Educational materials will be provided as a PDF file to both intervention and control groups. TPB-based educational materials will be only offered to the intervention group in the form of video and recorded audio.
Participants/Inclusion and exclusion criteria
Gestational age more than 12 weeks; Suffer from proper sleep; Mother age 15-45 years; Minimum literacy; No complications and diseases during pregnancy, including preeclampsia, eclampsia, gestational diabetes, and hydramnios; lack of experience of a stressful event other than Covid-19 disease for at least the last 6 months; lack of employment of the pregnant mother in the hospital and lack of employment in the night shift (due to the effect on sleep disorders); Do not suffer from mental-physical illness; Do not use tobacco, drugs, and sleeping pills; no history of infertility; the pregnant mother does not have Covid-19 disease now and in the past; Having the consent to enter the study; having a WhatsApp messenger or the possibility of installing this software on a mobile phone.
Intervention groups
The intervention group receives TPB-based training. The control group of the trainings in PDF format
Main outcome variables
Sleep quality; stress; coronary anxiety.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210801052045N1
Registration date:2021-08-08, 1400/05/17
Registration timing:prospective
Last update:2021-08-08, 1400/05/17
Update count:0
Registration date
2021-08-08, 1400/05/17
Registrant information
Name
zohreh rostamikia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5224 1954
Email address
z.rostamikia72@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-02, 1400/06/11
Expected recruitment end date
2021-09-07, 1400/06/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of educational intervention with mobile health technology and based on the theory of planned behavior on sleep quality, anxiety and perceived stress caused by the Covid-19 pandemic in pregnant women referred to urban health centers.
Public title
Evaluation of the effect of educational intervention with mobile health technology and based on the theory of planned behavior on sleep quality, anxiety and perceived stress caused by the Covid-19 pandemic in pregnant women referred to urban health centers.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age is more than 12 weeks (at the same time as the beginning of the 12th week of pregnancy and up to 2 months after delivery, women suffer from sleep problems and poor sleep quality.)
Mothers aged 15-45 years
Ability to read and write
No complications and diseases during pregnancy, including preeclampsia, eclampsia, gestational diabetes, and hydramnios
No experience of a stressful event other than Covid-19 disease during the past 6 months
Unemployment of the pregnant mother in the hospital and unemployment in the night shift (due to the effect on sleep disorders)
No mental or physical illness
No smoking, drugs, and sleeping pills
No history of infertility
Pregnancy of a pregnant mother with Covid-19 disease now and in the past
Having the consent to enter the study
Having a WhatsApp messenger or the possibility of installing this software on a mobile phone
Exclusion criteria:
Incidence of acute mental and physical illness
Premature rupture of membranes and preterm delivery
Abnormal fetal presentation
Pregnant mother with Covid-19
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The research units will be randomly assigned to the intervention or control group using quadruple permutation blocks.
In this way, the first six possible modes of blocks (AABB, ABAB, BBAA, BABA, ABBA, BAAB) are listed and each block will be assigned a number from one to six. Then, a number between one and six will be randomly selected using a table of random numbers, and then people will be assigned to the test group (A) and control (B) based on the block corresponding to the selected number. This will continue until the sample size is complete.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Training in this study is mobile health method and based on the theory of planned behavior.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Gonabad University of Medical Sciences
Street address
57.beheshti5.5, beheshti
City
Torbateheydariyeh
Province
Razavi Khorasan
Postal code
9543119689
Approval date
2021-07-13, 1400/04/22
Ethics committee reference number
IR.GMU.REC.1400.055
Health conditions studied
1
Description of health condition studied
Sleep quality
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Corona stress
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Corona anxiety
ICD-10 code
ICD-10 code description
4
Description of health condition studied
Behavior-based education
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sleap quality
Timepoint
Before intervention, immediately after intervention, 1 month after intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire
2
Description
Corona stress
Timepoint
Before intervention, immediately after intervention, 1 month after intervention
Method of measurement
Corona-related stress scale questionnaire
3
Description
Corona Stress Scale: CSS
Timepoint
Before intervention, immediately after intervention, 1 month after intervention
Method of measurement
Corona Disease Anxiety Scale)CDAS)
4
Description
Training based on the theory of planned behavior
Timepoint
Before intervention, immediately after intervention, 1 month after intervention
Method of measurement
Researcher-made questionnaire on the theory of planned behavior
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: Tashkia is an intervention group in WhatsApp software. 5 sessions of educational intervention in 2 sessions per week, each session for half an hour in the form of video and audio with pdf sessions. Educational materials based on the latest instructions of the Department of Maternal and Newborn Health of the Ministry of Health
Category
Behavior
2
Description
Control group: Control group: Form a control group in WhatsApp software. Only PDF tutorials are included in this group and also three questionnaires to complete
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Gonabad Urban Community Health Centers
Full name of responsible person
Gonabad University of Medical Sciences
Street address
Asian Roadside - University Campus-Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
1256897451
Phone
+98 51 5722 4083
Email
z.rostamikia72@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Fariba Askari
Street address
Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9156137374
Phone
+98 51 5722 0575
Email
faribaaskari10@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Zohreh Rostamikia
Position
Graduate student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
57. beheshti5.5
City
Torbatehedariyeh
Province
Razavi Khorasan
Postal code
9543113689
Phone
+98 51 5224 1954
Email
z.rostamikia72@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Fariba Askari
Position
Faculty member of Gonabad University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Asian Roadside - University Campus-Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
000000000000000
Phone
+98 51 5722 0575
Email
faribaaskari10@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Zohreh Rostamikia
Position
Graduate student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
57.Beheshti5.5
City
Tovbat-Heydariyeh
Province
Razavi Khorasan
Postal code
9543113689
Phone
+98 552241654
Email
z.rostamikia72@gmai.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
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
Undecided - It is not yet known if there will be 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