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IRCT20100913004736N26 IRCT 2022-03-09 Kermanshah University of Medical Sciences Comparison of the effect of aromatherapy and music therapy on anxiety of surgical patients Comparison of the effect of aromatherapy and music therapy on the level of anxiety of patients undergoing general surgery 2022-04-09 anticipated 236 Complete https://irct.ir/trial/60559 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Eligible patients will be enrolled in the study using the convenience method and will be assigned to one of the groups of music therapy, aromatherapy, a combination of aromatherapy and music therapy, and control, using random blocking method. Each block contains numbers from one to eight. Each patient is assigned a number from one to eight. Each group is assigned a letter (M to the music group, A to the aromatherapy group, AM to the group combining aromatherapy and music therapy, and C to the control group). A sequence is created for a sample size of 236 patients. For the random allocation concealment process, 30 opaque envelopes and 236 cards will be prepared. Inside each envelope, eight cards are placed in order. The number of blocks is written on each envelope. Patients are assigned to one of the study groups based on these letters. Random blocks will be generated by the statistics consultant. The process of randomly assigning patients to study groups will be performed by the researcher. To create a random sequence, permuted block randomization is used by generating eight blocks for four groups. Random sequences will be generated online through sealed www.envelope.com, Blinding description: The statistical advisor will not be aware of the names of the groups. N/A Anxiety. Intervention 1: First intervention group: In this group, one hour before surgery and for 30 minutes, inhalation aromatherapy with three drops of 25% rosemary essential oil (produced by Zardband Company-Iran) is performed. For this purpose, three drops of this essential oil are instilled onto a piece of cotton ball and attached to the patient's collar. The patient is then asked to breathe normally for 30 minutes. Intervention 2: Second intervention group: In this group, one hour before the surgery, a traditional song without words (song of Bidad), composed by Parviz Meshkatian, will be played for 30 minutes through headphones. Intervention 3: Third intervention group: In this group, one hour before surgery and for 30 minutes, a combination of aromatherapy and music therapy is used. For this purpose, three drops of this essential oil are instilled onto a piece of cotton ball and attached to the patient's collar. The patient is then asked to breathe normally for 30 minutes. Simultaneously with inhaling the rosemary scent, traditional music without words (song of Bidad), composed by Parviz Meshkatian is played through headphones. Intervention 4: Control group: In this group, aromatic distilled water is used. For this purpose, a very small amount of rosemary essential oil (in micrograms) is added to the distilled water. Three drops of this solution are instilled onto a piece of cotton ball and attached to the patient's collar. Then the patient is asked to breathe normally for 30 minutes. 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
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) Candidate of General Surgery Willingness to participate in the study 18 years and older Having preoperative pain and anxiety No history of allergies Healthy sense of smell Healthy sense of hearing No drug addiction 18 years no limit Both Having a history of mental illness Taking psychoactive drugs (anti-anxiety and anti-depressant drugs) from one week before the study Having thyroid diseases F06.4 Anxiety disorder due to known physiological condition Prevention Prevention Prevention Placebo First intervention group: In this group, one hour before surgery and for 30 minutes, inhalation aromatherapy with three drops of 25% rosemary essential oil (produced by Zardband Company-Iran) is performed. For this purpose, three drops of this essential oil are instilled onto a piece of cotton ball and attached to the patient's collar. The patient is then asked to breathe normally for 30 minutes. Second intervention group: In this group, one hour before the surgery, a traditional song without words (song of Bidad), composed by Parviz Meshkatian, will be played for 30 minutes through headphones. Third intervention group: In this group, one hour before surgery and for 30 minutes, a combination of aromatherapy and music therapy is used. For this purpose, three drops of this essential oil are instilled onto a piece of cotton ball and attached to the patient's collar. The patient is then asked to breathe normally for 30 minutes. Simultaneously with inhaling the rosemary scent, traditional music without words (song of Bidad), composed by Parviz Meshkatian is played through headphones. Control group: In this group, aromatic distilled water is used. For this purpose, a very small amount of rosemary essential oil (in micrograms) is added to the distilled water. Three drops of this solution are instilled onto a piece of cotton ball and attached to the patient's collar. Then the patient is asked to breathe normally for 30 minutes. Anxiety score in the State-Trait Anxiety Inventory. Timepoint: At the beginning of the study (before the intervention) and immediately after the intervention. Method of measurement: The State-Trait Anxiety Inventory (STAI). Kermanshah University of Medical Sciences Approved 2022-02-08 Ethics Committee of Kermanshah University of Medical Sciences Shahid Beheshti Blvd., Kermanshah Kermanshah Iran (Islamic Republic of)