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IRCT20230612058466N1 IRCT 2023-07-01 Ahvaz University of Medical Sciences The effect of nature-based sounds on nausea, vomiting, and stress The effect of nature-based sounds on nausea, vomiting, and stress in Acute myeloid leukemia patients undergoing chemotherapy 2023-06-22 anticipated 114 Complete https://irct.ir/trial/70678 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The method of assigning the intervention to people is randomly and by the method of randomized permutation blocks with random block sizes of 4, 6 and 8 (using the table related to random permutations). The randomization list is prepared by a statistician. The intervention used in this research is allocated according to the randomized list by a person outside the study who is not aware of the research objectives and according to the corresponding codes in the sealed envelopes, Blinding description: After selecting the samples, none of the sampled people will know about the randomization and the process of allocation to the groups. The researcher is given a pre-prepared list and enters the patients into the study in the order of the list numbers. Similar headphones are given to the patients of both groups. N/A Acute myeloid leukemia. Intervention 1: Intervention group: An MP3 device containing different sounds based on nature will be provided to the patients of the intervention group. These sounds include: the sound of birds, the sound of rain, the sound of a stream, the sound of a waterfall, walking in the forest. This will be done for 7 days. During the chemotherapy period, patients will be placed on their bed in whatever position they feel more comfortable (semi-sitting or supine position) and will listen to the set of sounds using headphones for 30 minutes in their rooms. The sound of headphones (25-50 dB) is adjusted so that it is satisfactory for the person and does not cause discomfort and ear irritation. Intervention 2: Control group: Control group: An MP3 device without any sound will be provided to patients in the control group. This will be done for 7 days. During the chemotherapy period, patients will be placed on their bed in whatever position they feel more comfortable (semi-sitting or supine position) and will put headphones in their ears without music for 30 minutes in their rooms. All control group participants will receive usual care. Yes - There is a plan to make this available What will be shared: The study report will be provided to the University of Medical Sciences. Also, the study will be published as an article. When: After the approval of the thesis To whom: The results of the study will be accessible to the researchers and the target group. Conditions: If necessary, the unidentifiable file in SPSS software format will be provided to Jundishapur University of Medical Sciences. Where to obtain: Central Library of Jundishapur University of Medical Sciences, Ahvaz; Library of the Faculty of Nursing and Midwifery; Responsible author and supervisor (Parisa Sheini-Jaberi: psheinijaberi@yahoo.com) How to obtain: send messages by e-mail; Refer to libraries Comments:
public Shahram Molavynejad
Golestan St.
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3373 8070 shahrambaraz@ajums.ac.ir Ahvaz University of Medical Sciences scientific Shahram Molavynejad
Golestan St.
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3373 8070 shahrambaraz@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Consent to enter the study Patients with recently diagnosed acute myeloid leukemia. (New cases) Patients who will undergo chemotherapy for the first time. Patients who have the same chemotherapy protocol. Patients who are fully conscious and not under airway intubation. Patients who are not in a critical health condition and listening to music is safe for them. No current smoking No drug addiction Patients who do not have respiratory and psychological diseases diagnosed by a physician. Ability to read and write Patients who are at least 18 years old. 18 years no limit Both Patients undergoing outpatient chemotherapy. Patients with hearing impairment. C92.0 Acute myeloid leukemia Prevention Prevention Intervention group: An MP3 device containing different sounds based on nature will be provided to the patients of the intervention group. These sounds include: the sound of birds, the sound of rain, the sound of a stream, the sound of a waterfall, walking in the forest. This will be done for 7 days. During the chemotherapy period, patients will be placed on their bed in whatever position they feel more comfortable (semi-sitting or supine position) and will listen to the set of sounds using headphones for 30 minutes in their rooms. The sound of headphones (25-50 dB) is adjusted so that it is satisfactory for the person and does not cause discomfort and ear irritation. Control group: Control group: An MP3 device without any sound will be provided to patients in the control group. This will be done for 7 days. During the chemotherapy period, patients will be placed on their bed in whatever position they feel more comfortable (semi-sitting or supine position) and will put headphones in their ears without music for 30 minutes in their rooms. All control group participants will receive usual care. The score of the Rhodes Nausea and Vomiting Severity Questionnaire is less than 9. The DASS-21 score for stress is less than 19. Timepoint: Before starting the intervention and then every day for 7 days. Method of measurement: Rhodes questionnaire to measure the severity and frequency of nausea and vomiting; DASS-21 questionnaire to measure stress. The quality of life score of the patients is at a good level. Timepoint: Before starting the intervention; 7 days and 30 days after the start of the intervention. Method of measurement: Quality of Life Questionnaire-Core 30 (QLQ-C30). Ahvaz University of Medical Sciences Approved 2023-05-27 Research ethics committee of Ahvaz Jundi Shapur University of Medical Sciences Golestan St. Ahvaz Khouzestan Iran (Islamic Republic of)