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IRCT20200630047962N1 IRCT 2020-08-21 Tehran University of Medical Sciences The effect of progressive muscle relaxation on covid-19 anxiety in pregnant women 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 2020-08-07 anticipated 126 Complete https://irct.ir/trial/49309 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The intervention is done in the form of virtual training by Skyroom, 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 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. N/A Covid-19 anxiety. Intervention 1: 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. Intervention 2: Control group: Routine pregnancy care. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No decision has been made yet
public Mojgan Zendehdel
No. 13, 7th floor east, block 18, opj town, Koohsar St., Shahran Square
Tehran Iran (Islamic Republic of) 1478894438 +98 21 4433 7260 Mojgan.zendehdel@gmail.com Tehran University of Medical Sciences scientific Mojgan Zendehdel
No. 13, 7th floor east, block 18, opj town, Koohsar St., Shahran Square
Tehran Iran (Islamic Republic of) 1478894438 +98 21 4433 7260 Mojgan.zendehdel@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Female 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 B34.2 Coronavirus infection, unspecified Other Other 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 Control group: Routine pregnancy care 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. Tehran University of Medical Sciences Approved 2020-08-03 Ethics committee of Tehran University of Medical sciences No. 13, 7th floor east, block 18, opj town, Koohsar St., Shahran Square Tehran Tehran Iran (Islamic Republic of)