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IRCT20210927052608N1 IRCT 2022-05-14 Mazandaran University of Medical Sciences Comparison of the effect of lavender inhalation and nature sounds on anxiety, hemodynamic parameters and pain in patients undergoing cataract surgery with regional anesthesia Comparison of the effect of lavender inhalation and nature sounds on anxiety, hemodynamic parameters and pain in patients undergoing cataract surgery with regional anesthesia 2022-04-14 anticipated 120 Complete https://irct.ir/trial/59419 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: A total of 120 eligible patients were selected continuously and after obtaining written consent, they will be randomly divided into three intervention groups with lavender, Voice of Nature and Control. For random assignment of samples in three groups, online software (https://www.randomizer.org/) will be used, code O for lavender, code A for the sound group and code C. For the control group, 120 envelopes are placed inside the envelope. In this method, 120 envelopes are written, and a number from 1 to 120 is written on the outside of each envelope. At the time of the patient's visit, it will be opened and based on the code inside the envelope and the list of numbers obtained by the software, in which the order of patients' visits and the code is set, the patient will be divided into one of three groups. N/A patients undergoing cataract surgery with regional anesthesia. Intervention 1: Patients in the intervention group with lavender, two drops of Alice lavender essential oil are instilled on a cotton ball and placed with a pin on the collar of the patient's clothing or near the patient's pillow, and the patient is asked to stand normally for 15 minutes To breathe. Intervention 2: Another intervention group is the nature of sound , which includes a combination of beach sounds, birds and rain. Wireless headphones are used to play music. Headphones can mask the sounds of the environment, so it makes the effect of the intervention clearer. The duration of playing the snature of sound, according to previous studies, is 15 minutes. The volume of nature's voice is adjusted by asking patients questions so that all patients receive a clear voice. Intervention 3: Control group: do not receive any Lavender and nature of sounds. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Reza Pourmohammad
Shahrak-e Vali Asr- azadegan1
Masal Iran (Islamic Republic of) 4381757399 +98 13 4366 4045 r_pourmohammad@yahoo.com Mazandaran University of Medical Sciences scientific Dr Ebrahim Nasiri Formi
Payambar Azam University Complex, Sari Paramedical School
sari Iran (Islamic Republic of) 4381757399 +98 11 3354 3246 rezanf2002@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients with cataracts physical and mental ability to answer questions willingness to participate in research having conscious satisfaction full awareness of place, time and surroundings able to understand and speak Persian no limit no limit Both Having a history of allergies to plants Having olfactory disorders The patient's unwillingness to listen to music Lack of verbal communication Taking anti-anxiety medication History of eye surgery Prevention Prevention Prevention Patients in the intervention group with lavender, two drops of Alice lavender essential oil are instilled on a cotton ball and placed with a pin on the collar of the patient's clothing or near the patient's pillow, and the patient is asked to stand normally for 15 minutes To breathe. Another intervention group is the nature of sound , which includes a combination of beach sounds, birds and rain. Wireless headphones are used to play music. Headphones can mask the sounds of the environment, so it makes the effect of the intervention clearer. The duration of playing the snature of sound, according to previous studies, is 15 minutes. The volume of nature's voice is adjusted by asking patients questions so that all patients receive a clear voice. Control group: do not receive any Lavender and nature of sounds. The primary outcome in this study was anxiety and hemodynamic changes. Timepoint: Before surgery, during surgery and 90 minutes after anesthesia. Method of measurement: To collect data, demographic information and disease information questionnaire, Spielberger manifest anxiety level questionnaire, hemodynamic index registration form and VAS scale for pain are used. Secondary consequences include pain, SPO2, and various possible complications such as nausea and vomiting and abdominal pain, headache, and other satisfaction. Timepoint: Before surgery, during surgery and 90 minutes after anesthesia. Method of measurement: . To collect data, demographic information and disease information questionnaire, Spielberger manifest anxiety level questionnaire, hemodynamic index registration form and VAS scale for pain are used. Mazandaran University of Medical Sciences Approved 2022-04-13 Ethics Committee of Mazandaran University of Medical Sciences Sari, Moallem Square, Deputy of Research and Technology sari Mazandaran Iran (Islamic Republic of)