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IRCT20200111046079N1 IRCT 2020-09-01 Khoram-Abad University of Medical Sciences The effect of hearing the sound on Non Stress Test(NST) results The effect of Maternal hearing the sound on Non Stress Test(NST) results 2020-08-21 anticipated 106 Complete https://irct.ir/trial/50500 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Randomization was simple with no substitution, so that two cards with numbers one and two, each of which represented the intervention and control group, were given to the first person,She, after selecting one of the cards. She entered the relevant group and the second person was automatically assigned to the opposite group of the previous person and again the cards were presented to the third person for selection and thus continued until the sampling was completed, Blinding description: In this study, which was performed in three-way blinds, a researcher colleague was used to randomly allocate samples to blind the researcher. After entering the special room for NST, the samples were performed by a fellow researcher to establish the sound of music, and for the control group, a headset device without playing music was placed on the ear of the control group, Therefore, the researcher was not able to distinguish the two groups of intervention and control. Finally, in order to evaluate and interpret the results of the study, which was performed by three people, including the researcher, a gynecologist and a reproductive health specialist, all individuals were unaware of the placement of the samples in the intervention and control groups. The data analyzer, who had the groups as the names of groups 1 and group 2, was unaware of the main nature of groups 1 and 2. N/A Fetal Heart Rate. Intervention 1: Intervention group: In the intervention group, pregnant women are routinely connected to an external fetal heart rate monitor to perform a Non Stress Test(NST) to assess the health of the fetus, and then a music player headset will be placed on the ear by the researcher assistance. And pregnant women will listen to non-verbal music throughout the 20-minute Non Stress Test(NST). It should be noted that the type of music and sound level will be the same in all members of the intervention group. Intervention 2: Control group: In this group, pregnant women are connected to the external fetal heart rate monitoring device to perform a Non Stress Test(NST) to assess the health of the fetus, and then the music player headset is turned off and only to blind the researcher and Observing the same conditions in both groups with the help of the researcher assistance be placed on people's ears during 20 minutes of Non Stress Test(NST). Yes - There is a plan to make this available What will be shared: All research results and data will be provided to Asali Educational Center and University When: In this plan, it is possible to access the results Six month after the final analysis of the data and the final report to the University of Medical Sciences To whom: Vice Chancellor for Research and Technology of the University, Asali Teaching Hospital, which is the place of research, and also those involved in the medical equipment industry to use the research results to upgrade the external fetal heart monitoring device. Conditions: To help invent and upgrade external fetal heart rate monitors Where to obtain: To use the data, applicants can contact Ms. Leila Fathi, faculty member of Lorestan University of Medical Sciences, at 09163677217, and email address MID_FATHI@YAHOO.COM, Khorramabad, 3 km from Khorramabad Road, Tehran, University campus complex to apply How to obtain: The applicant will be able to receive the results after obtaining the necessary permits from Lorestan University of Medical Sciences and after the approval of the Vice Chancellor for Research and Technology of the relevant university Comments:
public Leila Fathi
No. 53, Shahid Rahimifard Alley, Alavi St., Khorramabad
Khorramabad Iran (Islamic Republic of) 6813937798 +98 66 3332 2782 midwifer.fathi@gmail.com Khoram-Abad University of Medical Sciences scientific Leila Fathi
No. 53, Shahid Rahimifard Alley, Alavi St., Khorramabad
Khorramabad Iran (Islamic Republic of) 6813937798 +98 66 3332 2782 midwifer.fathi@gmail.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Auditory canal health gestational age 32-32 weeks single pregnancy with healthy fetus no symptoms of childbirth(Uterine contractions and pain, rupture of amniotic membrane, vaginal bleeding, etc.) no smoking, drugs or sedatives and drugs that cause maternal depression no limit no limit Female Maternal fasting Decreased amniotic fluid volume (oligohydramnios based on ultrasound evidence) Any unreliable pattern of fetal heart rate (including Decreased fetal heart rate, bradycardia, tachycardia, etc.) Other Other Intervention group: In the intervention group, pregnant women are routinely connected to an external fetal heart rate monitor to perform a Non Stress Test(NST) to assess the health of the fetus, and then a music player headset will be placed on the ear by the researcher assistance. And pregnant women will listen to non-verbal music throughout the 20-minute Non Stress Test(NST). It should be noted that the type of music and sound level will be the same in all members of the intervention group. Control group: In this group, pregnant women are connected to the external fetal heart rate monitoring device to perform a Non Stress Test(NST) to assess the health of the fetus, and then the music player headset is turned off and only to blind the researcher and Observing the same conditions in both groups with the help of the researcher assistance be placed on people's ears during 20 minutes of Non Stress Test(NST) Fetal heart rate Base Line. Timepoint: 20 minutes after the start of the study. Method of measurement: External electronic monitoring device for fetal heart. Beat to Beat Variability. Timepoint: 20 minutes after the start of the study. Method of measurement: External electronic monitoring device for fetal heart. Acceleration number. Timepoint: 20 minutes after the start of the study. Method of measurement: External electronic monitoring device for fetal heart. Test response time. Timepoint: 20 minutes after the start of the study. Method of measurement: External electronic monitoring device for fetal heart. Fetal Movement. Timepoint: 20 minutes after the start of the study. Method of measurement: External electronic monitoring device for fetal heart. Anxiety. Timepoint: 20 minutes after the start of the study. Method of measurement: Spielberger Questionnaire. Time required to respond to the Non Stress Test. Timepoint: Every minute until the end of twenty minutes. Method of measurement: External electronic monitoring device for fetal heart. Khoram-Abad University of Medical Sciences Approved 2019-02-17 Ethics Committee of Lorestan University of Medical Sciences Office of Research Ethics Committee, Vice Chancellor for Research and Technology Lorestan University of Medical Sciences., Pardis University Complex., 3 km of Khorramabad Tehran., Khorramabad Town Khoramabad Lorestan Iran (Islamic Republic of)