Protocol summary
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Study aim
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Determining the effect of nature-based sounds on nausea, vomiting and stress in acute myeloid leukemia patients undergoing chemotherapy
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Design
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The current study is a clinical trial with an intervention and control group, employing a double-blind, randomized design on 52 patients. SPSS software will be used for data analysis.
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Settings and conduct
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Patients in the intervention group will listen to the sounds of nature in their rooms for 30 minutes each time using headphones. The study tools will be completed by the participants before the intervention and every day during the chemotherapy period. Patients in the control group will receive usual care and wear headphones without music.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
People who have recently been diagnosed with acute myeloid leukemia (new cases)
Patients who will undergo chemotherapy for the first time.
The uniformity of the chemotherapy protocol of the patients.
People who are fully conscious.
The patient should not be in a critical state of health that would interfere with listening to music.
Not smoking at the present time.
No drug addiction.
Not suffering from respiratory and mental diseases diagnosed by a doctor.
Be able to read and write.
Exclusion criteria:
The patient's unwillingness to continue to cooperate in the research
Creating a critical situation that threatens the patient's life
death of the patient
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Intervention groups
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Intervention group: playing nature-based sounds through headphones and determining its effect on nausea, vomiting and stress
Control group: receiving routine interventions and receiving headphones without playing sound and determining its effect on nausea, vomiting and stress
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Main outcome variables
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Independent variable: Nature-based sounds
Dependent variables: nausea, vomiting, stress
General information
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Reason for update
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Changes have been made in the proposal after obtaining the code of ethics from Ahvaz Jundishapur University of Medical Sciences, which should be applied in the registered trial as well.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230612058466N1
Registration date:
2023-07-01, 1402/04/10
Registration timing:
prospective
Last update:
2026-04-15, 1405/01/26
Update count:
1
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Registration date
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2023-07-01, 1402/04/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-06-22, 1402/04/01
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Expected recruitment end date
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2023-12-22, 1402/10/01
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Actual recruitment start date
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2024-06-21, 1403/04/01
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Actual recruitment end date
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2025-03-15, 1403/12/25
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Trial completion date
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2025-03-15, 1403/12/25
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Scientific title
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The effect of nature-based sounds on nausea, vomiting, and stress in Acute myeloid leukemia patients undergoing chemotherapy
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Public title
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The effect of nature-based sounds on nausea, vomiting, and stress
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
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.
Exclusion criteria:
Patients undergoing outpatient chemotherapy.
Patients with hearing impairment.
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Investigator
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Sample size
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Target sample size:
114
Actual sample size reached:
52
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-05-27, 1402/03/06
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Ethics committee reference number
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IR.AJUMS.REC.1402.125
Health conditions studied
1
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Description of health condition studied
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Acute myeloid leukemia
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ICD-10 code
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C92.0
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ICD-10 code description
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Acute myeloid leukemia
Primary outcomes
1
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Description
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The score of the Rhodes Nausea and Vomiting Severity Questionnaire is less than 9. The DASS-21 score for stress is less than 19.
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Timepoint
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Before starting the intervention and then every day for 7 days
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Method of measurement
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Rhodes questionnaire to measure the severity and frequency of nausea and vomiting; DASS-21 questionnaire to measure stress
Secondary outcomes
1
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Description
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The quality of life score of the patients is at a good level.
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Timepoint
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Before starting the intervention; 7 days and 30 days after the start of the intervention
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Method of measurement
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Quality of Life Questionnaire-Core 30 (QLQ-C30)
Intervention groups
1
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Description
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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.
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Category
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Prevention
2
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Description
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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.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ahvaz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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The study report will be provided to the University of Medical Sciences. Also, the study will be published as an article.
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When the data will become available and for how long
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After the approval of the thesis
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To whom data/document is available
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The results of the study will be accessible to the researchers and the target group.
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Under which criteria data/document could be used
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If necessary, the unidentifiable file in SPSS software format will be provided to Jundishapur University of Medical Sciences.
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From where data/document is obtainable
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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)
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What processes are involved for a request to access data/document
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send messages by e-mail; Refer to libraries
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Comments
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