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The Effect of music on sleep quality of hemodialysis patients

Protocol summary

Summary
Main aim: To determine the effect of music on sleep quality in patients undergoing hemodialysis. Inclusion criteria: The age of the patients between 60-18 years,At least 6 months treated with hemodialysis, At least 2 times a week and a maximum of 3 times a week hemodialysis, The patient's history according to the sleep disorder is not a major handicap, hearing, cognitive or neurological disorders, sensory experience or not, have advanced heart disease and pulmonary edema, The patient is not suffering from mental disorders, The patient is not addicted to drugs, willingness to participate in the study and use of music have . Exclusion criteria: Cooperation in study discontinuation for any reason, during the study of major physical or mental patient for the accident happens, The patient is unwilling to continue the collaboration. Study design: Block randomization method using two intervention group and a control group of population are divided. Case study: All hemodialysis patients referred to the Hospital of hemodialysis Shiraz University of medical sciences. The sample size n = 105. Studied interventions: Before the start of the intervention of the questionnaire to all patients completed the Pittsburgh sleep quality. for a month for the two groups (Group during dialysis and group home before bedtime) music Play through headphones. One week after the end of the fourth week the Pittsburgh sleep quality questionnaire again for patients complete. During this period the control group received routine care

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016050217546N5
Registration date: 2016-05-15, 1395/02/26
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-05-15, 1395/02/26
Registrant information
Name
Marzieh Momennasab
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4254
Email address
momennasab@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellery for research affairs
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of music on sleep quality of hemodialysis patients
Public title
The Effect of music on sleep quality of hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The age of the patients between 60-18 years, At least 6 months treated with hemodialysis, At least 2 times a week and a maximum of 3 times a week hemodialysis, The patient's history according to the sleep disorder is not a major handicap, hearing, cognitive or neurological disorders, sensory experience or not, have advanced heart disease and pulmonary edema, The patient is not suffering from mental disorders, The patient is not addicted to drugs, willingness to participate in the study and use of music have . Exclusion criteria: Cooperation in study discontinuation for any reason, During the study of major physical or mental patient for the accident happens, The patient is unwilling to continue the collaboration.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz, 7th floor, Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran
City
Shiraz
Postal code
1978-71345
Approval date
2016-04-24, 1395/02/05
Ethics committee reference number
IR.SUMS.REC.1395.19

Health conditions studied

1

Description of health condition studied
chronic renal failure
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5

Primary outcomes

1

Description
sleep quality
Timepoint
before intervention, one week afterfinishing the intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The control group receives routine care
Category
N/A

2

Description
For a month for the two groups (Group during dialysis and group home before bedtime) music playback through headphones.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz Namazi Hospital, Mamasani Vali-e-Asr Hospital
Full name of responsible person
Mohsen ranjbar
Street address
Fars, Mamasani Vali-e-Asr Hospital
City
Mamasani

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellery for research affairs
Full name of responsible person
Dr Sayed Baser Hashemi
Street address
Shiraz, 7th floor, Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellery for research affairs
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marzieh momennasab
Position
Assisstant professor
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Namazi Square,Shiraz, Iran, Shiraz
City
Shiraz
Postal code
1978-71345
Phone
+98 71 3626 7101
Fax
Email
momennasab@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marzieh Momennasab
Position
Assisstant professor
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Namazi Square,Shiraz, Iran Shiraz
City
Shiraz
Postal code
1978-71345
Phone
+98 71 3626 7101
Fax
Email
momennasab@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohsen Ranjbar
Position
B.A
Other areas of specialty/work
Street address
Fars, Nourabad Mamasani, Nourabad Mamasani Vali-e-Asr Hospital
City
Nourabad Mamasani
Postal code
Phone
+98 71 4253 1080
Fax
Email
mohsenranjbar1393@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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