Determining the effect of nature-based sounds on nausea, vomiting and stress in acute myeloid leukemia patients undergoing chemotherapy
Design
The current study is a clinical trial with intervention and control groups, double-blind, randomized on 114 patients, and SPSS software will be used for data analysis.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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
The effect of nature-based sounds on nausea, vomiting, and stress in Acute myeloid leukemia patients undergoing chemotherapy
Public title
The effect of nature-based sounds on nausea, vomiting, and stress
Purpose
Supportive
Inclusion/Exclusion criteria
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 20 years old and at most 60 years old.
Exclusion criteria:
Patients undergoing outpatient chemotherapy.
Patients with hearing impairment.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
114
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committee of Ahvaz Jundi Shapur University of Medical Sciences
Street address
Golestan St.
City
Ahvaz
Province
Khouzestan
Postal code
6135733331
Approval date
2023-05-27, 1402/03/06
Ethics committee reference number
IR.AJUMS.REC.1402.125
Health conditions studied
1
Description of health condition studied
Acute myeloid leukemia
ICD-10 code
C92.0
ICD-10 code description
Acute myeloid leukemia
Primary outcomes
1
Description
The numerical rating scale (NRS) for the number of times nausea and vomiting is less than 4 times. The score of 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
Numerical measurement scale (NRS) for measuring the number of times nausea and vomiting; Rhodes questionnaire to measure the severity of nausea and vomiting; DASS-21 questionnaire to measure stress
Secondary outcomes
1
Description
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)
Intervention groups
1
Description
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.
Category
Prevention
2
Description
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.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Baghaei-2 Hospital
Full name of responsible person
Bijan Keikhaei
Street address
Golestan highway, Bagai square
City
Ahvaz
Province
Khouzestan
Postal code
6138933333
Phone
+98 61 3375 0410
Email
keikhaei-b@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
Golestan St.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 1544
Email
zakerkish-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahram Molavynejad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Golestan St.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8070
Email
shahrambaraz@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahram Molavynejad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Golestan St.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8070
Email
shahrambaraz@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Parisa Sheini-Jaberi
Position
lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Golestan St.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8070
Email
psheinijaberi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The study report will be provided to the University of Medical Sciences. Also, the study will be published as an article.
When the data will become available and for how long
After the approval of the thesis
To whom data/document is available
The results of the study will be accessible to the researchers and the target group.
Under which criteria data/document could be used
If necessary, the unidentifiable file in SPSS software format will be provided to Jundishapur University of Medical Sciences.
From where data/document is obtainable
Central Library of Jundishapur University of Medical Sciences, Ahvaz; Library of the Faculty of Nursing and Midwifery; Responsible author and supervisor (Shahram Molvinejad: shahrambaraz@ajums.ac.ir)
What processes are involved for a request to access data/document