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IRCT20100913004736N23 IRCT 2020-11-07 Kermanshah University of Medical Sciences The effect of aromatherapy and music on the anxiety and vital signs of patients undergoing lithotripsy Comparison of the effect of inhalation aromatherapy and music on anxiety and vital signs of patients under extracorporeal shock wave lithotripsy 2020-11-05 anticipated 176 Complete https://irct.ir/trial/48804 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Factorial, Purpose: Prevention, Randomization description: First, a random block of 8 will be created using the website https://www.sealedenvelope.com. Regarding the implementation of the random allocation process, the following are considered: A) Blocks of 8 are considered. B) One letter is assigned to each group: A to the band, B to the aromatherapy, C to the combination of music and aromatherapy, and D to none of the interventions (control group) C) A sequence of letters will be created for a sample size of 200. D) For the random allocation concealment process, 25 opaque envelopes and 200 cards will be created. Inside each envelope, eight cards are placed in sequence. The number of blocks is written on each envelope. On each card, the name of the desired group will be written in sequence, Blinding description: The person collecting sample information and controlling their vital signs, as well as the data analyst, are unaware of assigning samples to study groups. N/A Anxiety. Intervention 1: First intervention group (music group): In this group, during the lithotripsy, traditional Iranian music is played through headphones. Intervention 2: The second intervention group (aromatherapy group): In this group, during the lithotripsy, aromatherapy is performed with three drops of 25% Rose Damascena essential oil. Intervention 3: Third intervention group (music and aromatherapy group): In this group, a combination of traditional Iranian music and aromatherapy with three drops of 25% Rose Damascena essential oil is used. Intervention 4: Control group: There is no intervention in this group. 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 At the end of the study, the research team decides on this issue
public Alireza Khatony
Nurse Blvd., Imam Reza Hospital
Kermanshah Iran (Islamic Republic of) 6714634698 +98 83 3827 9394 Akhatony@kums.ac.ir Kermanshah University of Medical Sciences scientific Alireza Khatony
Nurse Blvd., Imam Reza Hospital
Kermanshah Iran (Islamic Republic of) 6714634698 +98 83 3827 9394 Akhatony@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study Age 18 to 65 years Literate Stability of vital signs Healthy sense of smell Healthy sense of hearing 18 years 65 years Both Previous history of lithotripsy drug addiction consumption of psychoactive drugs Any kind of allergy F43.0 Acute stress reaction Prevention Prevention Prevention Placebo First intervention group (music group): In this group, during the lithotripsy, traditional Iranian music is played through headphones. The second intervention group (aromatherapy group): In this group, during the lithotripsy, aromatherapy is performed with three drops of 25% Rose Damascena essential oil. Third intervention group (music and aromatherapy group): In this group, a combination of traditional Iranian music and aromatherapy with three drops of 25% Rose Damascena essential oil is used. Control group: There is no intervention in this group Anxiety score in Spielberger questionnaire. Timepoint: At the beginning of the study (before the start of the intervention) and immediately after the end of the lithotripsy. Method of measurement: Spielberger Anxiety Questionnaire. Blood pressure. Timepoint: At the beginning of the study (before the start of the intervention) and immediately after the end of the lithotripsy. Method of measurement: Mercury sphygmomanometer. Temperature. Timepoint: At the beginning of the study (before the start of the intervention) and immediately after the end of the lithotripsy. Method of measurement: Tympanic thermometer. Heart Rate. Timepoint: At the beginning of the study (before the start of the intervention) and immediately after the end of the lithotripsy. Method of measurement: Counting the number of radial pulse in one minute. Respiratory rate. Timepoint: At the beginning of the study (before the start of the intervention) and immediately after the end of the lithotripsy. Method of measurement: Counting the number of breaths in one minute. Kermanshah University of Medical Sciences Approved 2020-08-18 Ethics committee of Kermanshah University of Medical Sciences Shahid Behesht BLVD., Kermanshah Kermanshah Iran (Islamic Republic of)