1.Objectives: To assess the effects of music on anxiety, pain and hemodynamic parameters in patients with burns during dressing changes. 2. Design and how to do: This randomized clinical trial on 86 patients 2 and 3 bed burns in the burn Taleghani Hospital Ahwaz done in 1395. The samples were randomly assigned to two groups will be music and control so that each group contains 43 patients. 3.Participants including major eligibility criteria: desire to participate in the Study ability to read and write-ages of 18-60 years of addiction to drugs and alcohol Lack of mental illness-burn 10 to 45 percent with grade 2 and 3 - lack of burns to the head and face and ears .What having trouble hearing traverse at least 3 nights and exclusion criteria were discharged from the hospital during the study and wanting to continue to participate in the study. 4.Intervention: Patients for three consecutive days during a dressing change by entering the dressing room to run and to control their favorite music, usually performed dressing change. 5. main outcome: music reduced pain and anxiety as well as blood pressure and heart rate adjusted band in comparison with the control group of burn patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016100429733N2
Registration date:2017-01-29, 1395/11/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-29, 1395/11/10
Registrant information
Name
Aliakbar Ataeikachouei
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 9995
Email address
ataeik-aa@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the Effect of Music on Anxiety, Pain and Hemodynamic Parameters in Burn Patients During Dressing
Public title
The effect of music on burn pain
Purpose
Treatment
Inclusion/Exclusion criteria
Terms of Inclusion: Consent to Participate in Study; Ability to read and write; Age 18-60 years; Lack of addiction to drugs and alcohol; Lack of psychosexual disorders; Burn 10 to 45 percent with grade 2 & 3; No burns the head and face and ears; Lack of hearing problem; stay minimum 3 night
Terms of Exclusion: discharge during Study; The desire to withdraw from the study
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
86
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
Ethics Committee Ahvaz Jundishapur University of Medical sciences
Street address
Ahvaz Jundishapur University of Medical sciences, Ahvaz, Golestan Blvd
City
Ahvaz
Postal code
Approval date
2016-08-13, 1395/05/23
Ethics committee reference number
IR.AJUMS.REC.1395.344
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
T21-T22-T2
ICD-10 code description
Burn and corrosion of trunk,Burn and corrosion of shoulder and upper limb, except wrist and hand,Burn and corrosion of wrist and hand,Burn and corrosion of hip and lower limb, except ankle and foot,Burn and corrosion of ankle and foot
Primary outcomes
1
Description
Blood Presure
Timepoint
3 times in 3 days
Method of measurement
Mercury manometers
2
Description
Heart Rate
Timepoint
3 times in 3 days
Method of measurement
Manual
3
Description
pain
Timepoint
3 times in 3 days
Method of measurement
pain Chart
4
Description
Anxiety
Timepoint
3 times in 3 days
Method of measurement
Spielberger questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: The intervention group will run for three consecutive days during a dressing change by entering the dressing room their favorite music
Category
Treatment - Other
2
Description
Control: control group performed for dressing as usual, no music and for three days
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Burn Taleghani Hospital Ahvaz
Full name of responsible person
Fatemeh Jahangiri Mehr
Street address
Ayatollah Taleghani Hospital of Ahvaz, Khuzestan, Ahvaz, Amanollah Region, Mostaan Street
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Behzad Sharif Makhmal Zadeh
Street address
Ahvaz Jundishapur University of Medical sciences, Ahvaz, Golestan Blvd
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Fatemeh Jahangiri Mehr
Position
MSc in Biostatistics
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical sciences, Ahvaz, Golestan Blvd
City
Ahvaz
Postal code
Phone
+98 61 3372 1522
Fax
Email
afsjm.90@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Ali Akbar Ataei
Position
SubSpecialist of Plastic and Reconstructive Surgeon
Other areas of specialty/work
Street address
Ayatollah Taleghani Hospital of Ahvaz, Khuzestan, Ahvaz, Amanollah Region, Mostaan Street
City
Ahvaz
Postal code
6135715794
Phone
+98 61 3333 2368
Fax
+98 61 3336 1544
Email
ataeik-aa@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Fatemeh Jahangiri Mehr
Position
MSc in Biostatistics
Other areas of specialty/work
Street address
Ayatollah Taleghani Hospital of Ahvaz, Khuzestan, Ahvaz, Amanollah Region, Mostaan Street
City
Ahvaz
Postal code
6135715794
Phone
00
Fax
Email
afsjm.90@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)