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IRCT20230221057482N1 IRCT 2023-02-28 Tehran University of Medical Sciences Comparing the effects of aromatherapy and music therapy on preoperative anxiety A comparative study of the effect of aromatherapy and music therapy on physiological indices and preoperative anxiety of mastectomy candidates 2023-04-03 anticipated 99 Complete https://irct.ir/trial/68751 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In the first stage, samples are selected by convenience sampling. In this way, the samples that met the conditions for entering the study are chosen. In the second stage, the random assignment of samples is done by the random sequence created on the statistical website www.randomizer.org with a ratio of 1:1:1 to three groups of aromatherapy, music therapy and control so that in each group, 33 people are included. N/A Breast Cancer. Intervention 1: First intervention group: Aromatherapy; The aims and methods of this study will be explained to all eligible patients at the beginning of the study. Next, the researcher will complete the demographic and clinical characteristics questionnaire by interviewing the patients and referring to their medical records. Before performing any intervention, the base levels of state anxiety and measurable physiological indicators of systolic and diastolic blood pressure, heart rate, respiration, and arterial blood oxygen saturation will be measured with the Numeric Visual Analogue Anxiety Scale (NVAAS) and monitoring device, respectively. The data will be recorded immediately. To measure the baseline level of salivary cortisol, patients are instructed to throw away the remaining saliva in their mouth and then empty their saliva into the laboratory tube by spitting, a non-invasive and non-stimulating method. They first sit calmly for two minutes in a sitting position. After that, while slightly bent forward, they spit their saliva in a covered laboratory tube for a maximum of five minutes, three to five cc. The test tube is immediately placed in an ice box. To prepare for the intervention, a sterile cotton ball containing three drops of 20% rose essential oil (Rosa damascena) of Barij company will be prepared and attached to the patient's collar with a pin to maintain a distance of 15-20 cm from the nasal airway. 15 minutes later, this procedure is repeated. For privacy, patients are advised to lie comfortably in their beds and usually breathe for 30 minutes. During this period, patients are placed in their rooms without the presence of a nurse or caregiver and without care or treatment intervention. The patient is assured that the researcher is present and available in case of any problems or questions. After 30 minutes, aromatherapy will end. In order to make the intervention effective, 10 minutes after the completion of aromatherapy, the researcher will collect the post-intervention data, which includes state anxiety, measurable physiological indicators and salivary cortisol parameters. Intervention 2: Second intervention group: Music therapy; The aims and methods of this study will be explained to all eligible patients at the beginning of the study. Next, the researcher will complete the demographic and clinical characteristics questionnaire by interviewing the patients and referring to their medical records. Before performing any intervention, the base levels of state anxiety and measurable physiological indicators of systolic and diastolic blood pressure, heart rate, respiration, and arterial blood oxygen saturation will be measured with the Numeric Visual Analogue Anxiety Scale (NVAAS) and monitoring device, respectively. The data will be recorded immediately. To measure the baseline level of salivary cortisol, patients are instructed to throw away the remaining saliva in their mouth and then empty their saliva into the laboratory tube by spitting, a non-invasive and non-stimulating method. They first sit calmly for two minutes in a sitting position. After that, while slightly bent forward, they spit their saliva in a covered laboratory tube for a maximum of five minutes, three to five cc. The test tube is immediately placed in an ice box. To prepare for the intervention, the room conditions are the same as those of the aromatherapy group. The patients listen to the selected music for 30 minutes using headphones and MP3 players. Headphones are used to block out the sounds of the environment and allow the patient to concentrate better. At first, patients are provided with four pieces of music (traditional, classical, elemental, ambient genres) selected in the field of music therapy with 60-80 beats per minute. For each music, the patient is exposed to a maximum of 15 seconds. The patient chooses a piece that is closely related and feels more relaxing. Then he listens to the music for 30 minutes through headphones. Patients have the option to listen to the next piece of music or just select the same piece during music therapy. The patient adjusts the sound according to their comfort. Intervention 3: Control group: In the control group, routine nursing care is used. In this group, data collection and room and patient conditions are maintained as in the two intervention groups. However, no intervention is performed and only routine nursing care is used. Yes - There is a plan to make this available What will be shared: All non-identifiable data can be provided if required. When: The access period starts 1 month after the results are published To whom: All researchers working in scientific institutions and universities who send requests Conditions: When the copyright law is followed and data serves a relevant research purpose, the data can be used Where to obtain: Email Ms. Faezeh Samadi at f-samadi@razi.tums.ir How to obtain: Within one month of reviewing the application and the applicant's conditions, the data will be sent Comments:
public Faezeh Samadi
Imam Khomeini Hospital Complex, Dr Qarib St, Keshavarz Blvd
Tehran Iran (Islamic Republic of) 1419733141 +98 21 8474 2616 f-samadi@razi.tums.ir Tehran University of Medical Sciences scientific Esmaeil Mohammadnejad
School of Nursing and Midwifery of Tehran University of Medical Sciences, Dr. Mirkhani St., Tohid Square
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6105 4000 asreno1358@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Consent to participate in the study Female sex 18 to 65 years old age Stage 3 or 4 of breast cancer Performing surgery for the first time Having surgery on the same day Anxiety score of 5 or higher according to the NVAAS tool Not using sedatives and painkillers (at least in the last 24 hours) Not using drugs or corticosteroid products and other central nervous and endocrine system affecting drugs (according to medical records) Having a mental health condition Literacy in Persian reading and writing 18 years 65 years Female Olfactory dysfunction (for the aromatherapy group) Auditory impairment (for the music therapy group) Visual impairment (to measure anxiety using the NVAAS scale) History of allergies, eczema and respiratory diseases Reluctance and disinterest in listening to music Reluctance and disinterest in aromatherapy and rose essential oil C50-C50 Malignant neoplasm of breast Other Other Other First intervention group: Aromatherapy; The aims and methods of this study will be explained to all eligible patients at the beginning of the study. Next, the researcher will complete the demographic and clinical characteristics questionnaire by interviewing the patients and referring to their medical records. Before performing any intervention, the base levels of state anxiety and measurable physiological indicators of systolic and diastolic blood pressure, heart rate, respiration, and arterial blood oxygen saturation will be measured with the Numeric Visual Analogue Anxiety Scale (NVAAS) and monitoring device, respectively. The data will be recorded immediately. To measure the baseline level of salivary cortisol, patients are instructed to throw away the remaining saliva in their mouth and then empty their saliva into the laboratory tube by spitting, a non-invasive and non-stimulating method. They first sit calmly for two minutes in a sitting position. After that, while slightly bent forward, they spit their saliva in a covered laboratory tube for a maximum of five minutes, three to five cc. The test tube is immediately placed in an ice box. To prepare for the intervention, a sterile cotton ball containing three drops of 20% rose essential oil (Rosa damascena) of Barij company will be prepared and attached to the patient's collar with a pin to maintain a distance of 15-20 cm from the nasal airway. 15 minutes later, this procedure is repeated. For privacy, patients are advised to lie comfortably in their beds and usually breathe for 30 minutes. During this period, patients are placed in their rooms without the presence of a nurse or caregiver and without care or treatment intervention. The patient is assured that the researcher is present and available in case of any problems or questions. After 30 minutes, aromatherapy will end. In order to make the intervention effective, 10 minutes after the completion of aromatherapy, the researcher will collect the post-intervention data, which includes state anxiety, measurable physiological indicators and salivary cortisol parameters. Second intervention group: Music therapy; The aims and methods of this study will be explained to all eligible patients at the beginning of the study. Next, the researcher will complete the demographic and clinical characteristics questionnaire by interviewing the patients and referring to their medical records. Before performing any intervention, the base levels of state anxiety and measurable physiological indicators of systolic and diastolic blood pressure, heart rate, respiration, and arterial blood oxygen saturation will be measured with the Numeric Visual Analogue Anxiety Scale (NVAAS) and monitoring device, respectively. The data will be recorded immediately. To measure the baseline level of salivary cortisol, patients are instructed to throw away the remaining saliva in their mouth and then empty their saliva into the laboratory tube by spitting, a non-invasive and non-stimulating method. They first sit calmly for two minutes in a sitting position. After that, while slightly bent forward, they spit their saliva in a covered laboratory tube for a maximum of five minutes, three to five cc. The test tube is immediately placed in an ice box. To prepare for the intervention, the room conditions are the same as those of the aromatherapy group. The patients listen to the selected music for 30 minutes using headphones and MP3 players. Headphones are used to block out the sounds of the environment and allow the patient to concentrate better. At first, patients are provided with four pieces of music (traditional, classical, elemental, ambient genres) selected in the field of music therapy with 60-80 beats per minute. For each music, the patient is exposed to a maximum of 15 seconds. The patient chooses a piece that is closely related and feels more relaxing. Then he listens to the music for 30 minutes through headphones. Patients have the option to listen to the next piece of music or just select the same piece during music therapy. The patient adjusts the sound according to their comfort. Control group: In the control group, routine nursing care is used. In this group, data collection and room and patient conditions are maintained as in the two intervention groups. However, no intervention is performed and only routine nursing care is used. Anxiety score on the numerical visual analogue anxiety scale. Timepoint: At the beginning of the study and 10 minutes after the intervention has ended. Method of measurement: Numerical Visual Analogue Anxiety Scale. Physiological indices (systolic and diastolic blood pressure, heart rate, respiratory rate, arterial blood oxygen saturation and salivary cortisol level). Timepoint: At the beginning of the study and 10 minutes after the intervention has ended. Method of measurement: Monitor device, pulse oximetry, laboratory kit (by ELISA method). Tehran University of Medical Sciences Approved 2023-02-14 Ethics committee of Imam Khomeini Hospital Complex Research - Tehran University of Medical Sciences Room 604, 6th Floor, Central Building of Tehran University of Medical Sciences, Qods St, Keshavarz Blvd., Secretariat of Ethics Committee in Biomedical Research University of Tehran Tehran Tehran Iran (Islamic Republic of)