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Determining effects of massage and music with relaxation on pain intensity, anxiety and relaxation responses in burned patients

Protocol summary

Summary
The purpose of this study is to investigate the effect of massage and music with relaxation on pain intensity, anxiety and relaxation responses in burned patients. This is a randomized clinical trial with control group. Participants will be assigned randomly through random block sampling technique (quaternary units) without permutation to four groups: music therapy with relaxation, music with massage, massage and control group. During 3 days, these groups will be compared according to the effects of interventions on pain intensity, anxiety, pain anxiety and relaxation. Sample size in each group will be 57 and in total it will be 228 patients with burn who have eligibility criteria (including, every day dressing change, able to speak and oriented to time, person and place,and not in acute phase of burning) and signed consent form to take apart in the study. Before and after the intervention and after changing dressing, co-researcher will collect data related to pain intensity, anxiety, pain anxiety and relaxation by questionnaire and visual scale. Validity and reliability of questionnaires will be evaluated prior to gathering data. Finally data will be analyzed by statistical tests.

General information

Acronym
complementary therapy in burn patients
IRCT registration information
IRCT registration number: IRCT201202269143N1
Registration date: 2012-07-04, 1391/04/14
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-07-04, 1391/04/14
Registrant information
Name
Tahereh Najafi Ghezeljeh
Name of organization / entity
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4323
Email address
najafi_t@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining effects of massage and music with relaxation on pain intensity, anxiety and relaxation responses in burned patients
Public title
Determining effects of massage and music with relaxation on pain intensity, anxiety and relaxation responses in burned patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Iranian burn patients with every day dressing change; without respiratory damage; TBSA 10-45%, burn degree 2 or 3; able to speak (oriented to time, person and place); not in acute phase of burning; with background pain; without visual and hearing deficiency; without nerve damage in burn places; not taking cardiovascular drugs. Exclusion criteria: patients with psychological and cognitive disorders; infection in burn wound; critical situation for patient during study
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 228
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavars Blvd.,Ghods St., Central Office of Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2012-06-13, 1391/03/24
Ethics committee reference number
56689

Health conditions studied

1

Description of health condition studied
Burn patients
ICD-10 code
T29
ICD-10 code description
Burns and corrosions of multiple body regions

2

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

Primary outcomes

1

Description
relaxation
Timepoint
before, after intervention and after dressing change
Method of measurement
VAS

2

Description
Pain Anxiety
Timepoint
before dressing change
Method of measurement
BSPAR

3

Description
Anxiety
Timepoint
before, after intervention and before dressing change
Method of measurement
VAS

4

Description
pain intensity
Timepoint
before, after intervention and dressing change
Method of measurement
VAS

Secondary outcomes

empty

Intervention groups

1

Description
control group: without intervention
Category
Other

2

Description
music therapy: Patient preferred music, listening for 10 minutes by headphone with patient preferred music volume, once a day and prior to changing dressing
Category
Other

3

Description
music with massage: Patient preferred music, listening for 10 minutes by headphone with patient preferred music volume, simultaneous with Swedish massage for 10 minutes with patient privacy protection on patient’s healthy (not burned) parts of body, once a day and prior to changing dressing
Category
Other

4

Description
massage: Swedish massage for 10 minutes with patient privacy protection on patient’s healthy (not burned) parts of body, once a day and prior to changing dressing
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Motahari Clinical Educational Center
Full name of responsible person
fatemeh mohaddes ardabili
Street address
Motahari Hospital, Rashid Yasemi street, Valiasr street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Tahereh Najafi Ghezeljeh
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq. ,1419733171, 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
Tehran 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
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Tahereh Najafi Ghezeljeh
Position
PhD in Nursing/Faculty member
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq. ,1419733171, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6105 4323
Fax
Email
najafi_t@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Tahereh Najafi Ghezeljeh
Position
PhD in Nursing/Faculty member
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq. ,1419733171, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6105 4323
Fax
Email
najafi_t@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Tahereh Najafi Ghezeljeh
Position
PhD in nursing/faculty member
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq. ,1419733171, Tehran, Iran
City
Tehran
Postal code
Phone
00
Fax
Email
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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