This study was designed with the aim of determining the effect of nature sounds on sleep quality and fatigue in hemodialysis patients.
Design
This research is a randomized interventional study with a control group and Single blind. It will be conducted on 82 patients. For randomization, minimization method and sealed envelope will be used..
Settings and conduct
This research is a Single blind study (The outcome assessor will not know about the allocation of samples in the studied groups). which will be performed on patients referred to the dialysis department of Ali Ibn Abi Talib Hospital and Rafsanjan Special Medical Center. After obtaining the code of ethics, one of the researchers will refer to the research environment and explain the objectives of the research and how to do the work to the qualified patients. And the patients will complete a written informed consent form if they wish to participate in the research.
Participants/Inclusion and exclusion criteria
Being over 18 years old
Not having a medication regimen that affects the quality of sleep
Absence of hearing impairment
Obtaining a score above 5 on the PSQI scale
Intervention groups
In the intervention group, the sounds of nature will be played for 4 weeks, every night for 30 minutes, before going to bed. These people will be taught to lie down in a comfortable position while listening to music in a quiet environment with low light and a suitable and balanced temperature. Close your eyes and breathe regularly. For the control group, they should be placed in a quiet environment, with low light and suitable and balanced temperature, lie down in bed and in a comfortable position. Close your eyes and breathe regularly
Main outcome variables
sleep quality, fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230619058529N1
Registration date:2024-03-02, 1402/12/12
Registration timing:registered_while_recruiting
Last update:2024-03-02, 1402/12/12
Update count:0
Registration date
2024-03-02, 1402/12/12
Registrant information
Name
Amin Saharkhiz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5331 4234
Email address
amn.saharkhiz@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2025-04-04, 1404/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of natural sounds on fatigue and sleep quality of hemodialysis patients.
Public title
Investigating the effects of natural sounds on fatigue and sleep quality of hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being over 18 years old
No alcohol addiction or smoking
Having enough mental and cognitive power to answer questions and use hands-free or the presence of family members to help the patient to play music and use hands-free
Not experiencing a crisis during the past 6 months
Obtaining a score above 5 on the PSQI scale
Awareness of place, time and person
Not having a medication regimen that affects the quality of sleep
Exclusion criteria:
having hearing impairment
unwillingness to cooperate
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible samples will be placed in two intervention and control groups in a random minimization method (based on the classes of the sleep quality score of the basic measurement). The randomization units will be entered into the study individually, the first sample will be randomly drawn through a sealed envelope, and the next sample will be assigned to the next group with the same sleep quality class as the baseline measurement. This process will continue until reaching the desired sample size of the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
This research is a randomized intervention study with a control group and a Single blind, (The outcome assessor will not know about the allocation of samples in the studied groups).
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Rafsanjan University of Medical Sciences
Street address
NO 7717758764, School of Nursing and Midwifery, Nursing Boulevard, Rafsanjan, Kerman
City
rafsanjan
Province
Kerman
Postal code
7717758764
Approval date
2023-03-12, 1401/12/21
Ethics committee reference number
IR.RUMS.REC.1401.252
Health conditions studied
1
Description of health condition studied
The subject of study is not a disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sleep quality: the number of people who scored more than 6 from the Petersburg sleep quality questionnaire.
Timepoint
On the first day of the intervention, the pre-test will be performed. And within two days after the end of the intervention, sleep quality questionnaire will be filled again for both groups.
Method of measurement
Petersburg Sleep Quality Questionnaire
2
Description
Fatigue: Fatigue is described as a lack of mental and physical energy, and in this research, fatigue is the score obtained by patients from the multidimensional fatigue evaluation scale.
Timepoint
On the first day of the intervention, the pre-test will be performed. And within two days after the end of the intervention, a fatigue questionnaire will be filled again for both groups.
Method of measurement
Multidimensional fatigue questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group, the sounds of nature will be played for 4 weeks, every night for 30 minutes, half an hour before sleep. The sounds of nature used in this study will be the artwork "Sounds of Nature" by Dr. Arendstein, recorded in 2011.These sounds include birds chirping, sea waves, river and forest sounds and the sound of rain. The audio will be played in MP3 format. Before listening to the sounds of nature, these people will be taught to lie down in bed in a comfortable position, in a quiet room without anyone's traffic, with a suitable and balanced temperature and low light, while listening to the sounds of nature, adjust the volume to a level that they feel comfortable, not to worry about turning off the music, not to talk to anyone while listening, close their eyes while listening to the sounds of nature, and focus on them and breathe regularly.
Category
Treatment - Other
2
Description
Control group: It is also recommended for the control group to be placed in a quiet environment, with low light and a suitable and balanced temperature, to lie down in bed and in a comfortable position, similar to the intervention group. Close your eyes and breathe regularly.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rafsanjan University of Medical Sciences, Ali Ibn Abi Talib Hospital, Dialysis Department
Full name of responsible person
Tayyaba Naghban Banabi
Street address
NO 7717758764, School of Nursing and Midwifery, Nursing Boulevard
City
rafsanjan
Province
Kerman
Postal code
7717758764
Phone
+98 34 3425 5900
Email
negahbant@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Reza Vazirinejad
Street address
NO 7717758764, School of Nursing and Midwifery, Nursing Boulevard,
City
rafsanjan
Province
Kerman
Postal code
7717758764
Phone
+98 34 3425 5900
Email
negahbant@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Tayyaba Naghban Banabi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Nursing Boulevard
City
Rafsanjan
Province
Kerman
Postal code
7717758764
Phone
+98 34 3425 5900
Email
negahbant@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tayyaba Naghban Banabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Nursing Boulevard
City
Rafsanjan
Province
Kerman
Postal code
7717758764
Phone
+98 34 3425 5900
Email
negahbant@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Amin Saharkhiz
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Nursing Boulevard
City
Rafsanjan
Province
Kerman
Postal code
7717758764
Phone
+98 34 3425 5900
Email
Amn.saharkhiz@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available