Protocol summary

Study aim
Determining the effect of telemedicine-based massage training in spouses on the resilience of pregnant women during the Coronavirus pandemic
Design
A clinical trial with a control group, with parallel groups, without blinding, randomized, is performed on 120 pregnant women, and the center name lottery method was used for randomization.
Settings and conduct
Individuals with the research units' characteristics, which refer to Mashhad health centers for pregnancy care, are randomly selected from the health care providers' list to the researcher by easy sampling method. They are assigned in WhatsApp into two groups, intervention and control.
Participants/Inclusion and exclusion criteria
The informed consent form has been signed. Iranian and resident of Mashhad. One fetus in the present pregnancy. The mother's age is between 18 to 35. The least literacy of the mother and her husband is about fifth-grade at the elementary school. She has access to the internet and WhatsApp. She lives with her husband. She has a landline or cell phone number. The gestational age is between 28 and 34 weeks. In response to the DASS 21 questionnaire, she obtained less than 10, 14, 17, after depression, anxiety, and stress, respectively.
Intervention groups
After obtaining the informed consent and completing the research tools in the intervention group, a training session is held on cyberspace. Using a whiteboard, the researcher will teach the massage technique to the spouses and answer their questions. Re-contact is established two weeks after the start of the research. No training will be given in the control group, and contact will be re-established two weeks after the start of the research. Immediately after the intervention and four days after that, the research tool will be completed.
Main outcome variables
Determining the resilience

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170607034378N2
Registration date: 2020-11-19, 1399/08/29
Registration timing: registered_while_recruiting

Last update: 2020-11-19, 1399/08/29
Update count: 0
Registration date
2020-11-19, 1399/08/29
Registrant information
Name
Fatemeh Jalalmarvi
Name of organization / entity
Islamic Azad University of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 3751 5211
Email address
jalalmarvif941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-04, 1399/08/14
Expected recruitment end date
2021-03-04, 1399/12/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of telemedicine-based massage training in spouses on the resilience of pregnant women during the Coronavirus pandemic
Public title
The effect of massage training on the resilience of pregnant women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The informed consent form has been signed. Iranian and resident of Mashhad. One fetus in the present pregnancy. The mother's age is between 18 to 35. The least literacy of the mother and her husband is about fifth-grade at the elementary school. She has access to the Internet and WhatsApp. She lives with her husband. She has a landline or cell phone number. The gestational age is between 28 and 34 weeks. In response to the DASS21 questionnaire, she has obtained less than 10, 14, 17, after depression, anxiety, and stress, respectively.
Exclusion criteria:
An important and horrible event happened to her during the last 6 months. She has a medical history. She has a history of infertility or the current pregnancy is a result of infertility treatment. She or her husband has an addiction to tobacco (hookah, cigarettes, cheeks, drugs) or alcohol and psychosocial medications during the research. She has had the night shifts at work during the research. Skin problems such as scorch, skin wounds or bone problems such as fractures in the neck and back or legs. She has a speech, hearing or accent problems. She does not have the gynecological problems. She does the exercise regularly. She has a history of mental disorder.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Health Center No. 2 of Mashhad was selected from the five centers by cluster sampling method based on a lottery. Then, they were selected from the available health centers that were available and due to the possibility of information leakage, random assignment to two groups of intervention and control based on the names of the centers by lottery. Research units will also be randomly assigned so that mothers whose case number is even.
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 Islamic Azad university-mashhad Branch
Street address
Tehran - Ghods Town (West) - Between South Flamek and Zarafshan, Iran TV St. - Central Headquarters of the Ministry of Health, Treatment and Medical Education, Block A, 13th floor
City
Tehran
Province
Tehran
Postal code
9164697515
Approval date
2020-09-30, 1399/07/09
Ethics committee reference number
IR.IAU.MSHD.REC.1399.159

Health conditions studied

1

Description of health condition studied
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Resilience
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Resilience
Timepoint
Before the intervention, immediately after the intervention and 4 ِِdays after the intervention.
Method of measurement
Connor- Davidson Resilience Scale (CD-RISC)

Secondary outcomes

1

Description
Stress-Anxiety-Depression
Timepoint
Before the intervention, immediately after the intervention and 4 days after the intervention
Method of measurement
Stress-Anxiety-Depression scale

Intervention groups

1

Description
The intervention group: After obtaining the informed consent and completing the research tools in the intervention group, a training session is held on cyberspace. Using a whiteboard, the researcher will teach the "Aflorage" massage technique to the spouses and answer their questions. The participants will be asked to do a back massage by the spouse after establishing a calm environment and the mother's correct position for 10 minutes and each limb for 5 minutes (30 minutes in total). It is also asked to do the massage technique at nights before going to bed, three times a week every other day for 4 weeks (12 times in total). Re-contact is established two weeks after the start of the research. Immediately after the intervention and four days after that, the research tool will be completed.
Category
N/A

2

Description
The control group: No training will be given, and contact will be re-established 2 weeks after the start of the research. Before the intervention, immediately after the intervention, and 4 days after, the research tool will be completed.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Center No. 2
Full name of responsible person
Ali Asghar Mahmudi
Street address
Mashhad Health Center Street No. 2. Panjrah Paeen Khiaban.
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١۵٣٩١٣١۵٣
Phone
+98 51 3365 3000
Email
behdasht2@mums.ac.ir

2

Recruitment center
Name of recruitment center
14 Maesum Health Center
Full name of responsible person
Mahdi Sayad Kame Olya
Street address
North Tabarsi 35. 14 Maesum Health Center
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١۵٣٩١٣١۵٣
Phone
+98 51 3211 4110
Email
behdasht2@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Saeed Khayat Moghadam
Street address
Vice Chancellor for research and technology , Islamic Azad University,Imamamiye Aven,Ghasem Abad, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9234567124
Phone
+98 51 3620 4001
Email
research@mshdiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Fatemeh Jalal Marvi
Position
science Committee (coach)
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Islamic Azad University,Imamamiye Aven,Ghasem Abad, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9196685833
Phone
+98 51 3620 4001
Email
jalalmarvif9@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Jalal Marvi
Position
science Committee (Coach)
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Islamic Azad University,Imamamiye Aven,Ghasem Abad, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9196685833
Phone
+98 51 3620 4001
Email
jalalmarvif9@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Jalal Marvi
Position
science Committee (Coach)
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Islamic Azad University,Imamamiye Aven,Ghasem Abad, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9196685833
Phone
+98 51 3620 4001
Email
jalalmarvif9@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
No - There is not 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
Title and more details about the data/document
Only those parts of the data, such as the information about the main outcome or such things, can be shared.
When the data will become available and for how long
"Access period starts 6 months after the results are published"
To whom data/document is available
Only for researchers working in the academic and scientific institutions
Under which criteria data/document could be used
send mail Identify the person
From where data/document is obtainable
Send email to jalalmarvif9@gmail.com
What processes are involved for a request to access data/document
send mail Identify the person after one month
Comments
Loading...