]>
IRCT20100913004736N27 IRCT 2022-06-02 Arak University of Medical Sciences The effect of music therapy and aromatherapy on anxiety and physiological parameters Comparison of the effect of music therapy and aromatherapy on anxiety and physiological parameters of patients undergoing surgery 2022-07-23 anticipated 92 Complete https://irct.ir/trial/63642 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients are admitted to the study by convenience methods and randomly assigned to one of the study groups based on random blocking. Random sequences will be generated online through sealed www.envelope.com. Study groups include music therapy (A), aromatherapy (B), combination of music therapy and aromatherapy (C), and control (D). For the allocation concealment, 12 opaque envelopes and 92 cards will be prepared. Inside each envelope, 8 cards are placed. The number of blocks is written on each envelope. Abbreviation code (A, B, C and D) of each group is written on each card. Patients are placed in one of the study groups based on the codes on each card. This process is performed by the researcher, Blinding description: The study is single-blind, and the statistician is unaware of the equivalence of each code for each group from the beginning, and this ignorance will continue until the end of the data analysis. N/A Condition 1: Anxiety. Condition 2: Physiological indicators. Intervention 1: First intervention group: In the music group, non-verbal music is played through headphones for 30 minutes. Intervention 2: Second intervention group: In the aromatherapy group, three drops of 25% rosemary essential oil are poured on a piece of cotton ball and attached to the patient's collar. The patient is asked to breathe normally for 30 minutes. Intervention 3: Third intervention group: In this group, a combination of aromatherapy and music therapy is used. For this purpose, similar to the aromatherapy group, 25% rosemary essential oil is used for 30 minutes. Simultaneously with aromatherapy, non-verbal music is played to patients through headphones for 30 minutes. Intervention 4: In this group, headphones without sound playback, and aromatherapy with aromatic distilled water are used simultaneously. For aromatherapy, a very small amount (in micrograms) of 25% rosemary essential oil is added to distilled water and acts similarly to the aromatherapy 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 There is no more information
public Alireza Khatony
Parastar Blvd, Imam Reza Hospital
Kermanshah Iran (Islamic Republic of) 6714634698 +98 83 3427 6301 Akhatony@kums.ac.ir Kermanshah University of Medical Sciences scientific Alireza Khatony
Parastar Blvd., Imam Reza Hospital
Kermanshah Iran (Islamic Republic of) 6714634698 +98 83 3427 6301 Akhatony@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Consent to participate in the study No history of allergies Age over 18 years and under 65 years level of consciousness 15 based on the Glasgow Coma Scale Healthy sense of hearing Not having thyroid disease No drug addiction No psychiatric illness 18 years 65 years Both Patient request to leave the study Changing the level of consciousness Transferring the patient to another ward F06.4 Anxiety disorder due to known physiological condition Prevention Prevention Prevention Placebo First intervention group: In the music group, non-verbal music is played through headphones for 30 minutes. Second intervention group: In the aromatherapy group, three drops of 25% rosemary essential oil are poured on a piece of cotton ball and attached to the patient's collar. The patient is asked to breathe normally for 30 minutes. Third intervention group: In this group, a combination of aromatherapy and music therapy is used. For this purpose, similar to the aromatherapy group, 25% rosemary essential oil is used for 30 minutes. Simultaneously with aromatherapy, non-verbal music is played to patients through headphones for 30 minutes. In this group, headphones without sound playback, and aromatherapy with aromatic distilled water are used simultaneously. For aromatherapy, a very small amount (in micrograms) of 25% rosemary essential oil is added to distilled water and acts similarly to the aromatherapy group. Anxiety Score in Spielberger Questionnaire. Timepoint: Before and after the intervention. Method of measurement: Spielberger Questionnaire. Heart rate per minute. Timepoint: Before and after the intervention. Method of measurement: The value on the monitor. Percentage of oxygen saturation. Timepoint: Before and after the intervention. Method of measurement: The value on the monitor. Temperature. Timepoint: Before and after the intervention. Method of measurement: The value on the monitor. Blood pressure. Timepoint: Before and after the intervention. Method of measurement: The value on the monitor. Arak University of Medical Sciences Approved 2022-04-24 Research Ethics Committees of Arak University of Medical Sciences Pasteur Street Arak Markazi Iran (Islamic Republic of)