1. Home
  2. Approved trials
  3. » فارسی

Comparison of the effects of aroma therapy and music therapy on pain of burned patients

Protocol summary

Summary
The type of this study is clinical trial. The purpose of this study is comparison of the effects of aroma therapy and music therapy on pain level of burned patients. The number of samples are 48 burned patients that will hospitalize in burn ward in Shahid Sadoughi Burn Hospital in Yazd. The process of sampling will do during five month using the method of purposive sampling and the samples will place in two test groups (24 patients) using the software of random allocation. Inclusion criteria in this study is the patients that are in the range of 20 – 65 years old that can speak Persian and also clearly. The patients also should have a burn in the range of 25 % – 60 % and the depth of it are 2 and 3 grade. Exclusion criteria is the patients that have psychological disorders, allergic rhinitis, respiratory disorders, sinusitis, sleep disorders and a disorder that affect sense of smell and hearing and also; the patients that use Psychotic drugs and have have Inhalation burns or burn in head, neck and face exclude 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 questionnaire that check out their pain level in last night, on the next morning. then in forth night for 3 nights (20 minutes), the patients 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 questionnaire on the next morning. In aroma therapy group, in forth night for 3 nights (20 minutes), (the reasercher pure seven drops of lavand essence on the kleenex and then place the Kleenex on the plastic label and ask the patients to Inhalate it normally) and then fill the questionnaire on the next morning. The patients in both two test groups also use sedative and sleeping drugs if they needed. Finally, the average of pain level grade of patients in two test groups analyze both before and after music therapy and aroma therapy.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015042918395N2
Registration date: 2016-01-02, 1394/10/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-01-02, 1394/10/12
Registrant information
Name
Akram Amrollahi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1824 1751
Email address
amrollahi.akram@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2013-11-04, 1392/08/13
Expected recruitment end date
2014-04-02, 1393/01/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of aroma therapy and music therapy on pain of burned patients
Public title
Comparison of the effects of aroma therapy and music therapy on pain of burned patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: age of patients:20-65; language: persian; the ability to speak clearly; depth of burn:2,3 grade; total burn surface area: %25 - %60 Exclusion Criteria: the patients that have psychological disorders; the patients that have allergic rhinitis, respiratory disorders,sinositis; the patients that have a disorder that affect sense of smell and hearing; the patients that have sleep disorders; the patients that use Psychotic drugs; the patients that have Inhalation burns or burn in head, neck and face
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 48
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
Shahid Sadoughi University of Medical Sciences
Street address
Shahid Sadoughi University of Medical Sciences, Building Number 2, Shahid Sadoughi Street, Bahonar Square, Yazd, Iran
City
Yazd
Postal code
8916877441
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
119551

Health conditions studied

1

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

Primary outcomes

1

Description
pain level
Timepoint
before and after intervention
Method of measurement
Wong-Baker scale

Secondary outcomes

empty

Intervention groups

1

Description
In music therapy group, the reasercher will not do no intervention on patients in first three nights that patients are hospitalized in burn ward and only, on the next morning, patients fill a questionnaire that check out their pain level in last night, then in forth night for 3 nights (20 minutes), the patients 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 questionnaire on the next morning.
Category
Treatment - Other

2

Description
In aroma therapy group, the reasercher will not do no intervention on patients in first three nights that patients are hospitalized in burn ward and only, on the next morning, patients fill a questionnaire that check out their pain level in last night, then in forth night for 3 nights (20 minutes),(the reasercher pure seven drops of lavand essence on the kleenex and then place the Kleenex on the plastic lable and ask the patients to Inhalate it normally) and then fill the questionnaire on the next morning
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi Burn Hospital
Full name of responsible person
Akram Amrollhi
Street address
Shahid Sadoughi Burn Hospital, Paknejad Street, Moalem Street, Yazd, Iran
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Fatemeh Ezoddini
Street address
Shahid Sadoughi University of Medical Sciences, Building No 2, Shahid Sadoughi Street, BahonarSquare, Yazd, Iran
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi 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
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Akram Amrollhi
Position
Critical Care Nursing Master
Other areas of specialty/work
Street address
Shahid Sadoughi University of Medical Sciences, Building No 2, Shahid Sadoughi Street, Bahonar Square, Yazd, Iran
City
Yazd
Postal code
8916978477
Phone
+98 35 3824 1751
Fax
Email
amrollahi.akram@ssu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Akram Amrollhi
Position
Critical Care Nursing Master
Other areas of specialty/work
Street address
Shahid Sadoughi University of Medical Sciences, Building No 2, Shahid Sadoughi Street, Bahonar Square, Yazd, Iran
City
yazd
Postal code
8916978477
Phone
+98 35 3824 1751
Fax
Email
amrollahi.akram@ssu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Akram Amrollhi
Position
Critical Care Nursing Master
Other areas of specialty/work
Street address
Shahid Sadoughi University of Medical Sciences, Building No 2, Shahid Sadoughi Street, Bahonar Square, Yazd, Iran
City
Yazd
Postal code
8916978477
Phone
+98 35 3824 1751
Fax
Email
amrollahi.akram@ssu.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
Loading...