Protocol summary

Study aim
Determining the Effectiveness of Progressive Muscle Relaxation Technique on Coronary Anxiety in Pregnant Women Covered by the Ayat Comprehensive Health Service Center of Tehran University of Medical Sciences
Design
Clinical trial with control group, with parallel group, double-blind, randomized, on 126 patients. A random sequence generated by computer software was used for randomization.
Settings and conduct
Eligible individuals are selected from Ayat Health Center. Intervention group: Receiving routine pregnancy care with training in progressive muscle relaxation technique in 6 sessions of 40 minutes. Control group: receiving routine pregnancy care. Pregnancy Anxiety Questionnaire and Covid-19 Anxiety Scale are completed by the participants before the intervention, at the end of the intervention and two weeks after the intervention.
Participants/Inclusion and exclusion criteria
Admission requirements: Satisfaction for research, gestational age less than 32 weeks, literacy, access to smartphone, computer or laptop on the web, mild to moderate covid-19 anxiety level Conditions of non-admission: history of confirmed psychiatric illness, history of receiving any psychotherapy in the last 6 months, high-risk pregnancy, mothers with severe covid-19 anxiety, visual and hearing impairment,, migration in the last 6 months, hospitalization in the last 6 months, Loss of family member in the last 6 months, suicidal thoughts, history of poor pregnancy outcomes such as preterm delivery, miscarriage, stillbirth and fetal abnormalities in the past year
Intervention groups
Intervention group: routine prenatal care with virtual training of progressive muscle relaxation technique in 6 sessions (each session 40 minutes at a rate of 3 times a week)/Control group: routine pregnancy care
Main outcome variables
Covid-19 anxiety pregnancy anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200630047962N1
Registration date: 2020-08-21, 1399/05/31
Registration timing: registered_while_recruiting

Last update: 2020-08-21, 1399/05/31
Update count: 0
Registration date
2020-08-21, 1399/05/31
Registrant information
Name
Mojgan Zendehdel
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4433 7260
Email address
mojgan.zendehdel@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-07, 1399/05/17
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of progressive muscle relaxation technique on the level of covid-19 anxiety of pregnant women covered by the Ayat Comprehensive Health Services Center of Tehran University of Medical Sciences
Public title
The effect of progressive muscle relaxation on covid-19 anxiety in pregnant women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in research Gestational age less than 32 weeks Literacy for reading and writing Access to a smartphone, computer or laptop on the web Mild to moderate covid-19 anxiety levels
Exclusion criteria:
History of a confirmed psychiatric illness History of receiving any psychotherapy in the last 6 months High risk pregnancy Severe covid-19 anxiety level Visual and auditory impairment Immigration in the last 6 months Hospitalized in the last 6 months Loss of a family member in the last 6 months Suicidal thoughts History of poor pregnancy outcomes such as preterm labor, miscarriage, stillbirth and fetal malformations in the past year
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 126
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling is done by simple random method.The samples are divided into two groups A and group B based on a random sequence produced by computer software. Each patient receives a code.The pairing or individuality of the intervention or control group is determined by drawing lots. One group receives progressive muscle relaxation intervention with routine pregnancy care and one group receives only routine pregnancy care.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants receive prenatal care without knowing if they are in the intervention or control group. The outcome assessor also has no knowledge of assigning individuals to intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
The intervention is done in the form of virtual training by Skyroom

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical sciences
Street address
No. 13, 7th floor east, block 18, opj town, Koohsar St., Shahran Square
City
Tehran
Province
Tehran
Postal code
1478894438
Approval date
2020-08-03, 1399/05/13
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.287

Health conditions studied

1

Description of health condition studied
Covid-19 anxiety
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified

Primary outcomes

1

Description
Covid-19 disease anxiety
Timepoint
Before the intervention - immediately after the intervention - two weeks after the intervention
Method of measurement
Filling the Corona Disease Anxiety Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Routine prenatal care with 6 sessions of virtual intervention including information and awareness about coronavirus and anxiety-causing factors for pregnant mothers during coronavirus pandemics and training and practice of progressive muscle relaxation technique (each session 40 minutes) 3 times a week for each group) via Skyroom software
Category
Other

2

Description
Control group: Routine pregnancy care
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayat Comprehensive Health Services Center of Tehran University of Medical Sciences
Full name of responsible person
Mojgan Zendehdel
Street address
Ayat comprehensive Health Service Center, Shahid Zolfi St., Shahid Kazemi St., Ayatollah Saeedi Highway
City
Tehran
Province
Tehran
Postal code
1478894438
Phone
+98 21 4433 7260
Email
Mojgan.zendehdel@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadali Sahrayian
Street address
Keshavarz Boulevard and Ghods St. intersection, central building of Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1416663361
Phone
+98 21 8163 3600
Email
research@tums.ac.ir
Grant name
99-2-152-48830
Grant code / Reference number
99-2-152-48830
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mojgan Zendehdel
Position
Jobholder
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No. 13, 7th floor east, block 18, opj town, Koohsar St., Shahran Square
City
Tehran
Province
Tehran
Postal code
1478894438
Phone
+98 21 4433 7260
Email
Mojgan.zendehdel@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mojgan Zendehdel
Position
Jobhoder
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No. 13, 7th floor east, block 18, opj town, Koohsar St., Shahran Square
City
Tehran
Province
Tehran
Postal code
1478894438
Phone
+98 21 4433 7260
Email
Mojgan.zendehdel@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mojgan Zendehdel
Position
Jobholder
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No. 13, 7th floor east, block 18, opj town, Koohsar St., Shahran Square
City
Tehran
Province
Tehran
Postal code
1478894438
Phone
+98 21 4433 7260
Email
Mojgan.zendehdel@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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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