Protocol summary

Summary
This study is a clinical trial. The aim of this study was to compare the effect of music on sleep quality and pain in burn patients is preferred. The number of samples are 50 burned patients that will hospitalize in burn ward in Shahid Motahari Burn Hospital in Tehran. The process of sampling will do during five month using the method of purposive sampling and the samples will place in two groups (25 patients) using the software of random allocation. Inclusion criteria: Willingness to participate in the study; Ability to read and write; the patients that have sleep disorders; Age between 18 to 60 years old; Not drug and alcohol addicted; Not taking sleeping pills or anti-anxiety drugs; Having no mental disorders ؛depth of burn:2,3 grade; total burn surface area: %10 - %45; Having no burn the scalp, face and ears; Having no hearing impairment; Spend at least 3 nights of hospitalization; Understanding Persian language; Having no history of burns. Exclusion criteria: Discharge; Willingness to quit from the study. after knowing that the patients have inclusion criteria, the researcher will give them clear and understandable information about the method of study and then catch them a testimonial. In two groups, in the first three nights hospitalized in burn ward, researcher will not do no intervention on patients and only, patients fill the Pittsburgh sleep quality questionnaire and horizontal measurement tool for pain (VAS) on the next day, before sleeping. then in forth night for 3 nights (45 minutes), the patients in the intervention group will listen to their favorite and light music by choosing it from a list by a MP3player that has a headphone and then fill the questionnaires on the next day, before sleeping. In addition, patients in both groups, use sedative and sleeping drugs if they needed if they needed. Finally, the mean score of sleep quality and pain in two groups analyze before and after the intervention .

General information

Acronym
Not
IRCT registration information
IRCT registration number: IRCT2015111525054N1
Registration date: 2016-02-20, 1394/12/01
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-02-20, 1394/12/01
Registrant information
Name
Samira Abdi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3355 4145
Email address
abdi.s@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2015-10-02, 1394/07/10
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Favorite music effect on sleep quality and the underlying pain of burn patients
Public title
The effects of music on sleep quality and pain in burn patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Willingness to participate in the study; Ability to read and write; the patients that have sleep disorders; Age between 18 to 60 years old; Not drug and alcohol addicted; Not taking sleeping pills or anti-anxiety drugs; Having no mental disorders ؛depth of burn:2,3 grade; total burn surface area: %10 - %45; Having no burn the scalp, face and ears; Having no hearing impairment; Spend at least 3 nights of hospitalization; Understanding Persian language; Having no history of burns. Exclusion criteria: Discharge; Willingness to quit from the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Not

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Highway Hemmat, Tehran
City
Tehran
Postal code
Approval date
2015-08-05, 1394/05/14
Ethics committee reference number
IR.IUMS.REC.1394.9211196226

Health conditions studied

1

Description of health condition studied
Burn
ICD-10 code
T30.0
ICD-10 code description
Burn of unspecified body region, unspecified degree burn

Primary outcomes

1

Description
Pain
Timepoint
6 nights in a row
Method of measurement
Horizontal analogue scale VAS

2

Description
Quality of Sleep
Timepoint
6 nights in a row
Method of measurement
Pittsburgh Sleep Quality Index

Secondary outcomes

empty

Intervention groups

1

Description
In the experimental group, the second night of hospitalization, For 3 nights patients received no intervention and The day after the night before, Pittsburgh Sleep Quality Index and horizontal tool will complete pain assessment The average score of 3 nights will be achieved؛ Then the night quarter of the patients for 3 nights in music for 45 minutes using a player with headphones fall and The morning after patients have completed the questionnaires And the average score will be 3 nights before the intervention(Patients gentle instrumental music and your favorite music list has been prepared by the researcher selected).
Category
Treatment - Drugs

2

Description
The control group as well as groups, Pittsburgh Sleep Quality Index and Horizontal tool to measure pain will be completed in 6 consecutive nights, The difference is that the control group receiving only routine care And any intervention will be done for them and The only assess the quality of sleep and pain in proportion to the period, similar tests shall take place.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Martyr Motahari Burn Center in Tehran
Full name of responsible person
Samira Abdi Nursing Graduate Student
Street address
Motahari Burn Center in Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Iran University of Medical Sciences
Street address
Hemmat, Iran University of Medical Sciences, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Iran University of Medical Sciences
Street address
Hemmat, Iran University of Medical Sciences, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
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
Iran University of Medical Sciences
Full name of responsible person
Samira Abdi Nursing Graduate Student
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Hemmat, Iran University of Medical Sciences, Tehran, Iran
City
Tehran
Postal code
Phone
+243 35 54145
Fax
Email
abdi.s@tak.iums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Mohaddes
Position
Master of Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, St. martyr Rashid Yassami, Tehran
City
Tehran
Postal code
Phone
+243 35 54145
Fax
Email
abdi.s@tak.iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samira abdi
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Postal code
Phone
+243 35 54145
Fax
Email
Abdi.s@tak.iums.ac.ir
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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