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IRCT20220531055038N1 IRCT 2022-06-13 Saveh University of Medical Sciences The effect of counseling on coronary anxiety in pregnant women The Effect of Telephone Counseling on Covid-19-related Health Anxiety in Pregnant Women: A randomized controlled trial 2022-02-20 anticipated 85 Complete https://irct.ir/trial/63870 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Other design features: The consultation session consisted of two 30-minute phone conversations consisting of three parts. In part one, explanations were provided about coronavirus epidemiology in the region, definition and symptoms of the disease, how to care for pregnant women and protect them during the pandemic, how to schedule telephone counseling sessions and visits with gynecologists (to avoid unnecessary visits), providing the necessary information about the maternal-fetal transmission of the virus, answering to ambiguities around the choose of the right person who would follow the instructions during delivery, how to choose the safest place for delivery, how to breastfeed during the pandemic time, and how to care for the baby in the hospital and at home during the coronavirus era. Part two was dedicated to teaching relaxation techniques, which was accompanied by sending a file containing training about these techniques for ensuring better knowledge and practice. Finally, the 5-minute part three was considered for answering questions, following up for needs, and obviating the problems of the participant, Randomization description: This study was performed on 85 pregnant women referred to Saveh health centers. After obtaining the necessary approvals and attracting the participants, the objectives of the research were explained to them and the mothers were asked to sign their written consent. Random sampling was performed by participants from all five health centers in Saveh that provided midwifery services. First, a list of pregnant mothers was prepared and then, using a random number table, participants from each center (proportional to the number of mothers covered by them) were selected from among the eligible inclusion criteria. Then they were divided into intervention (A) and control (B) by block randomization method. First, 17 blocks of 5 are listed as follows: AAAAB, AAABB, AABBB, ABBBB,… Then these blocks were arranged using a table of random numbers and individuals were assigned to two groups according to A and B, Blinding description: Due to the nature of the study (counseling and training), which was not possible for the researcher and participant to be blinded, the analyzer and evaluator were given codes A and B. The intervention group received code A and control code B and had no information about the type of study and groups. N/A -. Intervention group: The participants were initially requested to complete a demographic checklist and the health anxiety questionnaire. The consultation session consisted of two 30-minute phone conversations consisting of three parts. In part one, explanations were provided about coronavirus epidemiology in the region, definition and symptoms of the disease, how to care for pregnant women and protect them during the pandemic, how to schedule telephone counseling sessions and visits with gynecologists (to avoid unnecessary visits), providing the necessary information about the maternal-fetal transmission of the virus, answering to ambiguities around the choose of the right person who would follow the instructions during delivery, how to choose the safest place for delivery, how to breastfeed during the pandemic time, and how to care for the baby in the hospital and at home during the coronavirus era. Part two was dedicated to teaching relaxation techniques, which was accompanied by sending a file containing training about these techniques for ensuring better knowledge and practice. Finally, the 5-minute part three was considered for answering questions, following up for needs, and obviating the problems of the participant. ONE - Two week after intervention, the health anxiety questionnaire was completed again via making phone calls to the participants.. No - There is not a plan to make this available Justification or reason for not sharing IPD is Participant data is confidential.
public Sahar Yazdi
Beheshti Ave,Fahmideh Blvd
saveh Iran (Islamic Republic of) 3919953649 +98 86 4225 0203 saharyazdi.1379@gmail.com Saveh University of Medical Sciences scientific Sahara yazdi
Beheshti Blvd, Fahmideh Ave
saveh Iran (Islamic Republic of) 3919953649 +98 86 4225 0203 saharyazdi.1379@gmail.com Saveh University of Medical Sciences Iran (Islamic Republic of) Pregnant women who refer to selected health centers Willing to participate in the study no limit no limit Female Inclusion criteria were willingness to participate in the study, no family conflicts or mental and psychological problems no history of any psychological disease no history of using antidepressants and psychiatric medications, and access to the telephone - - Behavior Intervention group: The participants were initially requested to complete a demographic checklist and the health anxiety questionnaire. The consultation session consisted of two 30-minute phone conversations consisting of three parts. In part one, explanations were provided about coronavirus epidemiology in the region, definition and symptoms of the disease, how to care for pregnant women and protect them during the pandemic, how to schedule telephone counseling sessions and visits with gynecologists (to avoid unnecessary visits), providing the necessary information about the maternal-fetal transmission of the virus, answering to ambiguities around the choose of the right person who would follow the instructions during delivery, how to choose the safest place for delivery, how to breastfeed during the pandemic time, and how to care for the baby in the hospital and at home during the coronavirus era. Part two was dedicated to teaching relaxation techniques, which was accompanied by sending a file containing training about these techniques for ensuring better knowledge and practice. Finally, the 5-minute part three was considered for answering questions, following up for needs, and obviating the problems of the participant. ONE - Two week after intervention, the health anxiety questionnaire was completed again via making phone calls to the participants. Primary outcome: health anxiety rate; In this study, the effect of telephone counseling on COVID-19-related health anxiety in pregnant women was investigated. The level of health anxiety was assessed using the Salkovskis and Warwick's health anxiety questionnaire by telephone before and after the intervention. Timepoint: 1 Month. Method of measurement: demographic checklist and the health anxiety Salkowski & Warwick questionnaire. Saveh University of Medical Sciences Approved 2020-12-23 Ethics committee of Saveh University of Medical Sciences Saveh university ,Behest Ave,Fahmideh Blvd Saveh Markazi Iran (Islamic Republic of)