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IRCT20170116031972N9 IRCT 2019-11-14 Kerman University of Medical Sciences Effect of lavender essential oils and orange spring on pain, anxiety and restlessness The effect of lavender essential oils and orange spring on pain, anxiety and restlessness of conscious patients admitted to intensive care units 2019-07-23 anticipated 105 Complete https://irct.ir/trial/40827 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples were randomly assigned to intervention and control groups. The method of random allocation is such that the first sample is placed in one of three groups using the lottery, then according to the variables of sex and age (2 ±) and addiction in the three groups are matched. Assignment of samples will be continued using the lottery and according to the matched variables. N/A Condition 1: Pain in vigilant patients in the intensive care unit. Condition 2: Restlessness in vigilant patients in the intensive care unit. Condition 3: Anxiety in vigilant patients in intensive care units. Intervention 1: Control group: Placebo (normal saline) is used for patients of this group in addition to the routine care (if the patient is suffering from pain, restlessness and anxiety, sedatives and haloperidol will be used according to the physician's order. Also, the doctor may request psychiatric counseling for the patient). First, the patient completes the pain, anxiety and restlessness questionnaire. Then, the gauze impregnated with 5 drops of normal saline is placed at a distance of 10 cm from the patient's nose (we will attach the gauze to the patient's collar). The patient is required to inhale it for 30 minutes. The pain, anxiety and restlessness questionnaire is recompleted by interviewing the patient immediately and one hour later. Intervention 2: First intervention group: The lavender essential oil is used in this group, in addition to the routine care. First, the questionnaires are completed by interviewing patients. Then, the gauze impregnated with 5 drops of the lavender oil is placed at a distance of 10 cm from the patient's nose (2%) (Made by Barij Essence of Kashan) (We will attach the gauze to the patient's collar). The patient is required to inhale it for 30 minutes. The questionnaires are recompleted immediately and one hour later. Intervention 3: Second intervention group: The orange blossom essential oil is used in this group, in addition to the routine care. First, the questionnaire is completed by interviewing the patient. Then, the gauze impregnated with 5 drops of the orange blossom essential oil (2%) (Made by Barij Essence of Kashan) is placed in a distance of 10 cm from the patient’s nose (we will attach the gauze to the patient's collar). The patient is required to inhale it for 30 minutes. The researcher will recomplete the questionnaires immediately and one hour later. It should be noted that sampling will be taken on the second day of the patient's admission to the intensive care unit. Also, sampling will be taken at 6-8 pm (due to reduced workload and patient's preparation for nighttime sleep). The questionnaires are completed by interviewing the patient. If the patient takes sedatives, the intervention will be done 3 hours later. Yes - There is a plan to make this available What will be shared: Results from this research are shared When: Start the access period 6 months after printing the results To whom: Researchers working in academic and scientific institutions and individuals in the industry Conditions: Data and results are presented after the request is reviewed Where to obtain: zahra karimzadeh Zahrakarimzadeh1391@gmail.com How to obtain: The request will be sent in writing to the Zahrakarimzadeh1391@gmail.com email address, after the review will be delivered to the requesting person. Comments:
public Zahra Karimzadeh
Campus of the University of Medical Sciences, Beginning of the Road of Seven Gardens
Kerman Iran (Islamic Republic of) 76169-13555 +98 34 3132 5600 Zahrakarimzadeh1391@gmail.com Kerman University of Medical Sciences scientific Zahra Karimzadeh
Campus of the University of Medical Sciences, Beginning of the Road of Seven Gardens
Kerman Iran (Islamic Republic of) 76169-13555 +98 34 3132 5600 Zahrakarimzadeh1391@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Able to read and write Normal sense of smell Stability of hemodynamic status Failure to receive accommodation 3 hours before or during intervention Absence of asthma and other chronic respiratory problems Do not miss the last 24 hours Absence of severe anxiety disorder with doctor's diagnosis Lack of eczema and allergies to plant and citrus substances 18 years 60 years Both The need for a sedative or sedative during the intervention R52 R45.1 F41.8 Pain, unspecified Restlessness and agitation Other specified anxiety disorders Placebo Other Other Control group: Placebo (normal saline) is used for patients of this group in addition to the routine care (if the patient is suffering from pain, restlessness and anxiety, sedatives and haloperidol will be used according to the physician's order. Also, the doctor may request psychiatric counseling for the patient). First, the patient completes the pain, anxiety and restlessness questionnaire. Then, the gauze impregnated with 5 drops of normal saline is placed at a distance of 10 cm from the patient's nose (we will attach the gauze to the patient's collar). The patient is required to inhale it for 30 minutes. The pain, anxiety and restlessness questionnaire is recompleted by interviewing the patient immediately and one hour later. First intervention group: The lavender essential oil is used in this group, in addition to the routine care. First, the questionnaires are completed by interviewing patients. Then, the gauze impregnated with 5 drops of the lavender oil is placed at a distance of 10 cm from the patient's nose (2%) (Made by Barij Essence of Kashan) (We will attach the gauze to the patient's collar). The patient is required to inhale it for 30 minutes. The questionnaires are recompleted immediately and one hour later. Second intervention group: The orange blossom essential oil is used in this group, in addition to the routine care. First, the questionnaire is completed by interviewing the patient. Then, the gauze impregnated with 5 drops of the orange blossom essential oil (2%) (Made by Barij Essence of Kashan) is placed in a distance of 10 cm from the patient’s nose (we will attach the gauze to the patient's collar). The patient is required to inhale it for 30 minutes. The researcher will recomplete the questionnaires immediately and one hour later. It should be noted that sampling will be taken on the second day of the patient's admission to the intensive care unit. Also, sampling will be taken at 6-8 pm (due to reduced workload and patient's preparation for nighttime sleep). The questionnaires are completed by interviewing the patient. If the patient takes sedatives, the intervention will be done 3 hours later. Effect of lavender essential oils and orange spring on pain. Timepoint: The pain rate was completed before and immediately before the study, 1 hour after the intervention (placebo, lavender essential oil and orange spring). Method of measurement: VSA pain scale. Effect of lavender essential oils and orange spring on anxiety. Timepoint: The anxiety level was completed before the study immediately and 1 hour after the intervention (placebo, lavender and orange spring). Method of measurement: Spielberger Anxiety Inventory. Effect of lavender essential oils and orange spring on restlessness. Timepoint: The amount of restlessness was completed by the patient before and immediately and 1 hour after the intervention (placebo, lavender and orange spring). Method of measurement: Richmond Rescue Inventory. Kerman University of Medical Sciences Approved 2019-07-06 Ethics Committee of Kerman University of Medical Sciences Campus of the University of Medical Sciences, Beginning of the Road of Seven Gardens kerman Kerman Iran (Islamic Republic of)