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IRCT20200512047414N1 IRCT 2021-01-16 Mashhad University of Medical Sciences The effect of Citrus aurantium essential oil on sleep quality during pregnancy The effect of aromatherapy with Citrus aurantium essential Oil on sleep quality during pregnancy 2021-01-19 anticipated 70 Complete https://irct.ir/trial/53207 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: By www.randomization.com, a random sequence is determined for 70 people in groups A and B. This sequence is kept in a closed door envelope and each time one of the research units that met the inclusion criteria, the envelope door is opened and according to its code, it enters the intervention group or control group. The selection of codes A and B for the two groups will be done by lottery. 3 Sleep disorders in pregnant women. Intervention 1: Intervention group: For a month, twice a day (once before going to bed at night) and each time pour 5 drops of spring orange essential oil (prepared from university-approved health centers, soaked in 1: 3 volume ratio in sweet almond oil as a neutral base oil for two weeks) on the mask and inhale it for 20 minutes each time with normal breathing. The most chemical composition of prepared spring orange essential oil was linalool 45-47%. Intervention 2: Control group: For one month, twice a day (once before going to bed at night) and each time pour 5 drops of sweet almond oil (prepared from university-approved health centers) on the mask and inhale it for 20 minutes each time with normal breathing. Yes - There is a plan to make this available What will be shared: All collected deidentified IPD are to be shareable after the results of study get published on reasonable inquiry. When: Access period starts 6 months after the results are published To whom: Researchers and students from academic institutions Conditions: With citing to the current study and without altering in data. Where to obtain: Contact with author responsible for responsiveness with following email/phone mohammadipf971@mums.ac.ir Tel: 09162436044 How to obtain: Request to access data/document will be assessed with the research team. Comments:
public Fereshteh Mohammadi Pay Andar
Ibne Sina St. School of Nursing and Midwifery
Mashhad Iran (Islamic Republic of) 13944-91388 +98 51 3841 2081 mohammadipf971@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Maryam Maryam
Ibne Sina St. School of Nursing and Midwifery
Mashhad Iran (Islamic Republic of) 13944-91388 +98 51 3841 2081 mohammadipf971@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Have informed consent to participate in the study. Be at least literate. Have Iranian nationality. Be a resident of Jiroft. From the DASS-21 questionnaire, get a depression score of less than 21, an anxiety score of less than 15, and a stress score of less than 26. Having a gestational age of 34-28 weeks. Have a singleton pregnancy. Get a score of 5 or higher on the Pittsburgh Sleep Quality Questionnaire (PSQI). Not having a cold. Not having allergic to spring orange essential oil or sweet almond oil. Not having a disorder in sense of smell. Not being allergic to plant odors, herbal essential oils, perfumes and colognes. Not having a known sleep disorder before pregnancy. Do not experienced tragic events in the last six months. Not using tobacco, alcohol and drugs. Have a known history of mental illness. 18 years 35 years Female Do not want to continue the study. Use other techniques for sleep disorders during the study. Experience severe stress during the study. Getting feverish infectious diseases during the study. Being hospitalized during the study. Getting cold or a disorder in sense of smell. Showing allergic to spring orange essential oil or sweet almond oil. Not using spring orange essential oil or sweet almond oil for 2 days or using only once a day for three days. G47.9 Sleep disorder, unspecified Treatment - Drugs Placebo Intervention group: For a month, twice a day (once before going to bed at night) and each time pour 5 drops of spring orange essential oil (prepared from university-approved health centers, soaked in 1: 3 volume ratio in sweet almond oil as a neutral base oil for two weeks) on the mask and inhale it for 20 minutes each time with normal breathing. The most chemical composition of prepared spring orange essential oil was linalool 45-47%. Control group: For one month, twice a day (once before going to bed at night) and each time pour 5 drops of sweet almond oil (prepared from university-approved health centers) on the mask and inhale it for 20 minutes each time with normal breathing. The overall score of sleep disorder. Timepoint: Measurement of sleep quality score at the beginning of the study (before the intervention) and one month after the start of spring orange essential oil consumption ". Method of measurement: Petersburg Sleep Quality Questionnaire. Student Research Committee Approved 2020-11-17 "Ethics Committee of Mashhad University of Medical Sciences" Mashhad, Ibne Sina St., School of Nursing and Midwifery Mashhad Razavi Khorasan Iran (Islamic Republic of)