Protocol summary

Summary
The aim of study was to compare the effect of music and relaxation on dressing pain intensity of burn patients. Inclusion criteria: Patients age 20 to 55 years; Burn surface 36-9%; Partial thickness burns; unintentional burn; able to speak and understand Persian language; Dressing dumped into a routine method; In the 48 hours after the burn and wound closure time before being detained; Do not have ears burn; without mental disorders; without Neurological disorders and numbness in the target burned organs; No extreme difficulty hearing; Interested in instrumental music. Exclusion criteria: unwillingness to cooperate; inability to obtain necessary skills in relaxation; have ears burn; mental disorders; Neurological disorders and numbness in the target burned organs; extreme difficulty hearing; not interested in instrumental music. The population consisted of patients admitted to the burn unit of Tohid Hospital in Sanandaj city and Besat Hospital in Hamadan city. Sample size was estimated45 patients for each group. The music and relaxation were interventions. It takes 4 months. The primary outcome was pain intensity observed for each patient by means Visual Analogue Scale.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016020826453N1
Registration date: 2016-07-09, 1395/04/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-07-09, 1395/04/19
Registrant information
Name
Hiwa Azami
Name of organization / entity
hamedan university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 87 3362 6310
Email address
oshvandi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of music with relaxation on burn patients' dressing pain intensity.
Public title
The comparison of music with relaxation on burn patients' dressing pain intensity.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Patients age 20 to 55 years; Burn surface 36-9%; Partial thickness burns; unintentional burn; able to speak and understand Persian language; Dressing dumped into a routine method; In the 48 hours after the burn and wound closure time before being detained; Do not have ears burn; without mental disorders; without Neurological disorders and numbness in the target burned organs; No extreme difficulty hearing; Interested in instrumental music. Exclusion criteria: unwillingness to cooperate; inability to obtain necessary skills in relaxation; have ears burn; mental disorders; Neurological disorders and numbness in the target burned organs; extreme difficulty hearing; not interested in instrumental music.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Hamadan University of Medical Sciences
Street address
Hamadan
City
Hamadan
Postal code
6617619651
Approval date
2015-06-20, 1394/03/30
Ethics committee reference number
IR.UMSHA.REC.1394.167

Health conditions studied

1

Description of health condition studied
burn
ICD-10 code
T30
ICD-10 code description
Burn and corrosion, body region unspecified

Primary outcomes

1

Description
pain intensity
Timepoint
After dressing
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Music therapy group: instrumental music to be played for 20 minutes before dressing for patients.
Category
Treatment - Other

2

Description
The relaxation group: Relaxation was done by patient according to instruction for 20 minutes before dressing.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Toohid and Besat Hospitals
Full name of responsible person
Hiwa Azami
Street address
Besat Hospital, Shihid Beheshti Ave.
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vic-Chncellor of Research and Thecnology, Hamadan University of Medical Sciences
Full name of responsible person
Saeid Bashirian
Street address
Hamadan
City
Hamadan
Grant name
از محل یک درصد بودجه طرح های تحقیقاتی دانشگاه
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vic-Chncellor of Research and Thecnology, Hamadan University of Medical Sciences
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
Hamadan University of Medical Sciences
Full name of responsible person
Hiwa Azami
Position
Ms.c Critical Care Nursing
Other areas of specialty/work
Street address
Hamadan
City
Hamadan
Postal code
6517619651
Phone
+98 81 3525 0182
Fax
Email
hiva_aso_2006@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Departmen of Nursing & Midwifery, School of Surgical Nursing
Full name of responsible person
Khodayar Oshvandi
Position
PhD/Assistant Professor
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences
City
Hamadan
Postal code
6517619651
Phone
+98 81 3525 0182
Fax
Email
hiva_aso_2006@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Hiwa Azami
Position
Ms.c Ciritical Care Nursing
Other areas of specialty/work
Street address
Hamadan
City
Hamadan
Postal code
6517619651
Phone
+98 81 3525 0182
Fax
Email
hiva_aso_2006@yahoo.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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