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IRCT20231213060353N1 IRCT 2024-02-27 Shiraz University of Medical Sciences Evaluation of the effectiveness of Melissa Officinalis L. nasal drop on the quality of sleep in pregnant women Evaluation of the effectiveness of Melissa Officinalis L. nasal drop on the quality of sleep in pregnant women 2024-01-21 anticipated 100 Complete https://irct.ir/trial/74642 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, all study groups will contain equal sample size, which can be used by limited randomization. The method that is used in this study, will be permuted block randomization . In this method, the size of all blocks will be equal and 10 blocks of 10 will be selected by the "Random software allocation" software, which is capable of generating a random sequence using the permutation block method. The randomization unit in this study will be an individual unit, Blinding description: The method of blinding is double-blind, and the researcher is not aware of the contents of the drops, and only the person's name is entered in the randomization table based on the code that the person has. The oils whose content is unknown and only have A and B labels, are given to patients by one of the pharmacy colleagues. 3 Sleep quality of pregnant women in the third trimester. Intervention 1: Intervention group: pregnant women suffering from sleep disorders referring to the pregnancy clinic of Mahdiyeh Hospital: a prepared and approved sample of Melissa Officinalis will be poured into a standard amount of neutral oil and then a standard amount of sterile water will be added to it. then It will be expousered to indirect heat so the water will completely be evaporated, and finally, the remaining plant will be filtered from the oil so the final product of lemongrass plant oil will be derived from it. The method of using neutral oil (placebo) and lemon balm oil (intervention) is to drip one drop of the respective oil in each nostril twice a day . The medication will be consumed for 8 weeks. The drops will be made by the Faculty of Traditional Medicine of Tehran University of Medical Sciences. Intervention 2: Control group: pregnant women suffering from sleep disorders referring to pregnancy clinic of Mahdiyeh Hospital who receive neutral oil. neutral oil is an oil that has no effect in the treatment of sleep disorder and its preparation is industrial and contains liquid Paraffin.The drops will be made by the Faculty of Traditional Medicine of Tehran University of Medical Sciences. 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 Privacy of participants
public Zahra Rastegari
Fatemeh (P.B.U.H) School of nursing and midwifery, Namazi hospital, Namazi square, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7193613119 +98 71 3647 4254 rategariz@sums.ac0ir Shiraz University of Medical Sciences scientific Zahra Rastegari
Fatemeh (P.B.U.H) School of nursing and midwifery, Namazi hospital, Namazi square, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7193613119 +98 71 3647 4254 rategariz@sums.ac0ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study Gestational age of 28-34 weeks after obtaining informed consent Mother's first pregnancy (mother's nulligravidity) Suffering from mild and moderate sleep disorder by self-report and according to the Pittsburgh Questionnaire Ability to answer questionnaire questions Not using complementary medicine during the previous three months No dependence or addiction to alcohol, drugs, tobacco and medicines Not having family problems No history of any respiratory allergy Not having a history of allergy to Lemon balm or cross-reaction with the mint family as self-reported 15 years 45 years Female Taking drugs that affect the sleep-wake cycle The presence of any problems in the pregnancy process Suffering from depression or anxiety (self-reported and the need to take medication) Suffering from any psychological factor interfering with sleep disorders Suffering from kidney diseases, heart failure, respiratory disorders and sleep-wake cycle diseases such as espiratory apnea and restless leg syndrome. Showing any allergic reaction to lemon balm oil continuous consumption (twice or more per week) of Lemongrass tea or extract during the last month having problems related to airway and nasal obstruction and Sinusitis Treatment - Drugs Treatment - Drugs Intervention group: pregnant women suffering from sleep disorders referring to the pregnancy clinic of Mahdiyeh Hospital: a prepared and approved sample of Melissa Officinalis will be poured into a standard amount of neutral oil and then a standard amount of sterile water will be added to it. then It will be expousered to indirect heat so the water will completely be evaporated, and finally, the remaining plant will be filtered from the oil so the final product of lemongrass plant oil will be derived from it. The method of using neutral oil (placebo) and lemon balm oil (intervention) is to drip one drop of the respective oil in each nostril twice a day . The medication will be consumed for 8 weeks. The drops will be made by the Faculty of Traditional Medicine of Tehran University of Medical Sciences. Control group: pregnant women suffering from sleep disorders referring to pregnancy clinic of Mahdiyeh Hospital who receive neutral oil. neutral oil is an oil that has no effect in the treatment of sleep disorder and its preparation is industrial and contains liquid Paraffin.The drops will be made by the Faculty of Traditional Medicine of Tehran University of Medical Sciences. Percentage of pregnant women who have sleep disorders. Timepoint: Registration of Pittsburgh sleep quality questionnaire at the beginning of the study (before the start of the intervention) and 4 and 8 weeks after starting the use of Lemon balm oil drops. Method of measurement: Pittsburgh sleep quality questionnaire. Sleep quality score. Timepoint: At the beginning of the study and 4 and 8 weeks after the beginning of Lemon balm oil drops. Method of measurement: Pittsburgh Sleep Quality Questionnaire. Shiraz University of Medical Sciences Approved 2023-09-09 Ethics committee of Shiraz University of Medical Sciences No. 39, Joahari Naad Ave., Shir Mohamadi St. , Nazi Abad, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)