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IRCT20220423054626N1 IRCT 2023-03-02 Mashhad University of Medical Sciences The efficacy of husband’s support on maternal anxiety and stress of pregnant women undergoing the amniocentesis The effect of husband’s support on maternal anxiety and stress of pregnant women undergoing the amniocentesis 2023-03-12 anticipated 90 Complete https://irct.ir/trial/63181 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Method: Randomized blocking based on PASS_11 software with 4 blocks Random unit: All pregnant mothers who meet the study entry criteria. Tools: Blocked closed packets based on software Concealment: The sealed packets of the people that have been prepared using the PASS_11 software are selected at the same time as the mother enters the study. Based on the assigned number in each group, the people are assigned to two intervention and control groups, Blinding description: Those who evaluate the outcome. N/A Amniocentesis. Intervention group: For the wives of pregnant women in the intervention group, a face-to-face briefing session will be held for 45 to 60 minutes, two to seven days before the amniocentesis. Stress and anxiety of pregnant women and the effect of their presence and support on their husbands in reducing their stress and anxiety level from the time of knowing about the procedure, during the procedure, post-amniocentesis care, how to respond and They will be given time to go to the centers to receive the result. They are also asked to be present with and support their spouses during the amniocentesis. This support will include both physical and psychological parts. In the physical support section, the man takes the pregnant mother's hand with one hand and caresses her with the other hand, facing the mother's face so that she does not see the amniocentesis. In the psychological support section, the man establishes eye contact with the pregnant mother and reminds her of a pleasant memory in order to take his wife's mind away from the sampling area, and the researcher controls and records all these cases through a checklist. In both groups, the amniocentesis will be the same. To do the amniocentesis, the person lies on a test bed and to minimize the risk of infection, the abdomen is disinfected using alcohol. An ultrasound doctor uses a sonography to determine the exact location of the bladder to minimize the risk of harm to the fetus. This may take up to 20 minutes. The doctor then inserts a long, thin needle into the bladder through the abdominal wall and, under ultrasound guidance, closely monitors the process. The doctor removes the required amount of amniotic fluid with a syringe and then removes the needle. Getting fluid may take a few minutes, but it usually takes less than 30 seconds. It is worth mentioning that Spielberg Anxiety Questionnaire, Depression, Anxiety and Stress Questionnaire DASS-21 (Stress Section) by pregnant women in both groups were completed by self-report before and after amniocentesis. The spouse will be present with the pregnant mother while filling out the questionnaire.Also, all these things are done in the presence of the researcher.. 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 Sampling has not started yet.
public Fatemeh Salehi
Ebne_Sina Street
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 Salehif951@mums.ac.ir Mashhad University of Medical Sciences scientific MahinTafazoli
Ebne_Sina Street
Mashhad Iran (Islamic Republic of) 9 913791319 +98 51 3859 1511 tafazolim@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Gestational age: 15-18 weeks Ability of reading and writing couples Satisfaction for participation in the project candidate of amniocentesis Score 20-59 from the Spielberger Anxiety Questionnaire on the Manifest's Anxiety Scale (mild to moderate) Obtain a stress score greater than 14 and less than 26 from the DASS-21 questionnaire 18 years no limit Female History of infertility and Pregnancy with assisted reproductive techniques History of amniocentesis Taking psychiatric drugs History of mental illness and hospitalization due to mental health problems for at least the last 6 months Z36.0 Encounter for antenatal screening for chromosomal anomalies Behavior Intervention group: For the wives of pregnant women in the intervention group, a face-to-face briefing session will be held for 45 to 60 minutes, two to seven days before the amniocentesis. Stress and anxiety of pregnant women and the effect of their presence and support on their husbands in reducing their stress and anxiety level from the time of knowing about the procedure, during the procedure, post-amniocentesis care, how to respond and They will be given time to go to the centers to receive the result. They are also asked to be present with and support their spouses during the amniocentesis. This support will include both physical and psychological parts. In the physical support section, the man takes the pregnant mother's hand with one hand and caresses her with the other hand, facing the mother's face so that she does not see the amniocentesis. In the psychological support section, the man establishes eye contact with the pregnant mother and reminds her of a pleasant memory in order to take his wife's mind away from the sampling area, and the researcher controls and records all these cases through a checklist. In both groups, the amniocentesis will be the same. To do the amniocentesis, the person lies on a test bed and to minimize the risk of infection, the abdomen is disinfected using alcohol. An ultrasound doctor uses a sonography to determine the exact location of the bladder to minimize the risk of harm to the fetus. This may take up to 20 minutes. The doctor then inserts a long, thin needle into the bladder through the abdominal wall and, under ultrasound guidance, closely monitors the process. The doctor removes the required amount of amniotic fluid with a syringe and then removes the needle. Getting fluid may take a few minutes, but it usually takes less than 30 seconds. It is worth mentioning that Spielberg Anxiety Questionnaire, Depression, Anxiety and Stress Questionnaire DASS-21 (Stress Section) by pregnant women in both groups were completed by self-report before and after amniocentesis. The spouse will be present with the pregnant mother while filling out the questionnaire.Also, all these things are done in the presence of the researcher. Pregnant mother anxiety level. Timepoint: At the beginning of the study and before and after amniocentesis. Method of measurement: Spielberger Anxiety Questionnaire - DOS21 Questionnaire - Spouse Supportive Behavior Checklist. Pregnant mother stress level. Timepoint: At the beginning of the study and before and after amniocentesis. Method of measurement: Anxiety and Depression Stress Questionnaire DASS 21. Mashhad University of Medical Sciences Approved 2021-10-26 Ethics committee of Mashhad University of Medical Sciences Ebne sina Mashhad Razavi Khorasan Iran (Islamic Republic of)