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IRCT20090810002324N17 IRCT 2020-12-22 Iran University of Medical Sciences Aromatherapy and music on the Non-Stress Test and anxiety. The Effect of aromatherapy and music on the Non-Stress Test and anxiety in primiparous women. 2021-02-08 anticipated 195 Complete https://irct.ir/trial/51378 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Each of the two intervention and the control groups will be assigned one of the codes A, B or C. Randomization will be done using six blocks and determination of blocks will be done using R statistical program. For concealment, each block will be placed in an opaque envelope. Each envelope will be randomly selected by one of the study participants. Participants will be placed in one of the two intervention or the control groups based on the codes in each of the specified blocks, Blinding description: Interpretation of non - stress tests in all groups will be done by two research assistants (Specialist in perinatology) who unaware of the group's allocation. All questionnaires will be gathered by the research assistant who unaware of the group's allocation. N/A State and trait anxiety. Intervention 1: Intervention group: The first Intervention group aromatherapy: At first, the mother will be placed in a quiet room. Twenty minutes before performing the non-stress test (NST), four drops of 10% Lavender essential oil (Made by the Barij Essence Pharmaceutical Company) will be dripped on a 10*10 Polyethylene napkin and attach to the mother’s collar of clothes. For the mothers of this group, to eliminate the ambient sounds, headphones will be placed without playing music. The mother will typically inhale the aroma for 20 minutes. After removing the Polyethylene napkin and headphones, the mother will be ready for the test. The NST will be performed for 20 minutes using a Fetal monitoring device. Intervention 2: Intervention group: aromatherapy and music: At first, the mother will be placed in a quiet room. Twenty minutes before performing the NST, four drops of 10% Lavender essential oil (Made by the Barij Essence Pharmaceutical Company) will be dripped on a 10*10 Polyethylene napkin and attach to the mother’s collar of clothes. Simultaneously with the aroma of lavender, the music (sounds of nature) will be played through headphones for 20 minutes by selecting the type of music and the volume of the tuning sound according to the mother's desire (with a maximum of 45 dB). After removing the Polyethylene napkin and headphones, the mother will be ready for the test. The NST will be performed for 20 minutes using a Fetal monitoring device. Intervention 3: Control group: At first, the mother will be placed in a quiet room. Twenty minutes before performing the NST, four drops of distilled water, as a placebo, will be dripped on a 10*10 Polyethylene napkin and attach to the mother’s collar of clothes. The mother will typically inhale it for 20 minutes. For the mothers of this group, to eliminate the ambient sounds, headphones will be placed without playing music. After removing the Polyethylene napkin and headphones, the mother will be ready for the test. The NST will be performed for 20 minutes using a Fetal monitoring device. 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 Decisions will be made in the future.
public Maryam Keshavarz
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St., Tehran, IRAN
Tehran Iran (Islamic Republic of) 1996713883 +98 43651813 keshavarz.m@iums.ac.ir Iran University of Medical Sciences scientific Maryam Keshavarz
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St., Tehran, IRAN
Tehran Iran (Islamic Republic of) 1996713883 1996713883 keshavarz.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Maternal age 18 - 40 years. Gestational age of 32 - 41 weeks of pregnancy (from accurate Last menstruation period or first - trimester ultrasound). Wanted pregnancy. Stable hemodynamic status in mother (blood pressure higher than 80/60 mm/Hg). passage of at least 1.5 - 2 hours from the last meal. 18 years 40 years Female History of infertility or the use of assisted reproductive techniques. Vaginal bleeding and uterine contraction. Any fetal abnormalities and amniotic fluid disorders. Using painkillers and sedatives in the last 24 hours. Hearing disorders. Addiction to drugs, psychotropic substances, and cigarettes. Neurological problems. Respiratory diseases and a history of allergies to plant essential oils. Prevention Prevention N/A Intervention group: The first Intervention group aromatherapy: At first, the mother will be placed in a quiet room. Twenty minutes before performing the non-stress test (NST), four drops of 10% Lavender essential oil (Made by the Barij Essence Pharmaceutical Company) will be dripped on a 10*10 Polyethylene napkin and attach to the mother’s collar of clothes. For the mothers of this group, to eliminate the ambient sounds, headphones will be placed without playing music. The mother will typically inhale the aroma for 20 minutes. After removing the Polyethylene napkin and headphones, the mother will be ready for the test. The NST will be performed for 20 minutes using a Fetal monitoring device. Intervention group: aromatherapy and music: At first, the mother will be placed in a quiet room. Twenty minutes before performing the NST, four drops of 10% Lavender essential oil (Made by the Barij Essence Pharmaceutical Company) will be dripped on a 10*10 Polyethylene napkin and attach to the mother’s collar of clothes. Simultaneously with the aroma of lavender, the music (sounds of nature) will be played through headphones for 20 minutes by selecting the type of music and the volume of the tuning sound according to the mother's desire (with a maximum of 45 dB). After removing the Polyethylene napkin and headphones, the mother will be ready for the test. The NST will be performed for 20 minutes using a Fetal monitoring device. Control group: At first, the mother will be placed in a quiet room. Twenty minutes before performing the NST, four drops of distilled water, as a placebo, will be dripped on a 10*10 Polyethylene napkin and attach to the mother’s collar of clothes. The mother will typically inhale it for 20 minutes. For the mothers of this group, to eliminate the ambient sounds, headphones will be placed without playing music. After removing the Polyethylene napkin and headphones, the mother will be ready for the test. The NST will be performed for 20 minutes using a Fetal monitoring device. The mean Score and severity of State anxiety of Spielberger questionnaire. Timepoint: Before the intervention, 15 minutes after the end of NST. Method of measurement: The State anxiety of Spielberger questionnaire. The mean score and severity of trait anxiety of Spielberger questionnaire. Timepoint: Before the intervention, after the end of NST. Method of measurement: The trait anxiety of Spielberger questionnaire. Reactive and non- reactive of NST. Timepoint: After the end of NST. Method of measurement: Checklist. The number of acceleration of fetal heart rate. Timepoint: During the NST Procedure. Method of measurement: Checklist. The number of fetal movement. Timepoint: During the NST Procedure. Method of measurement: Checklist. Minimum time for the test to be positive. Timepoint: During the NST Procedure. Method of measurement: Checklist. Blood pressure. Timepoint: Measuring the blood pressure will be done in a sitting position before performing the intervention. After completing the NST, on the left side of the supine position, the blood pressure will be re-measured. Method of measurement: Digital sphygmomanometer. Iran University of Medical Sciences Approved 2020-10-21 کمیته اخلاق دانشگاه علوم پزشکی ایران تهران، بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران Tehran Tehran Iran (Islamic Republic of)