(1)The purpose of this Experimental clinical trail with the control group is to investigate the effect of rhythmic breathing on pain and anxiety of burn dressing change in hospitalized patients admitted to Ayatollah Mousavi Educational Hospital Zanjan Province. (2) Sample: Available sample of 60 patients,(3) Anxiety and Pain will be assessed before going to dressing room and after dressing in experimental group and control group. This work will continue for three consecutive day (4) Aged 18 to 60, TBSA %9-35, burn degree 2 or 2 and 3, able to speak and understand Persian, wound dressing by wards’ routines, no self-inflicted burn. For prevent bias, initially, the control group and then the intervention group entered the study.(5) The procedure will be explained to each patient. A written instruction about the procedure will be given to the experimental group. (6) Pain and anxiety will be measured with Visual Analogue Scale (VAS) scoring procedure: The scores of each tool range from 0-10.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016052928153N1
Registration date:2016-07-02, 1395/04/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-02, 1395/04/12
Registrant information
Name
Hamed Azizkhani
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3527 0472
Email address
hamedazizi25@gmail.com
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-11-05, 1395/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of rhythmic breathing on the anxiety and pain of dressing in burned
Public title
The Effect of rhythmic breathing on the anxiety and pain of dressing in burned
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:The patient is in hospital four days؛ Older than 18؛Do not have a burn-relief؛ Lack of electricity and chemical burns and burning؛ The level of between 10% to 45% with some degree burns include 1, 2, 3؛The ability to communicate verbally and understand the language of Persian؛ Ability to read and write؛ The ability to carry out co-respiratory؛ Lack of drug addiction؛ Lack of mental illness؛ severe hearing and vision problems have.
The exclusion criteria: reluctance of patients to participate in research ؛ Patients who for any reason can not reach the necessary skills؛ Discharged during the study.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
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 of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Between The Highway Martyr Chamran and Martyr Sheikh Fazlullah Nuri, Martyr Hemmat Highway ,Tehran, Iran.
City
Tehran
Postal code
4798-19395
Approval date
2016-05-07, 1395/02/18
Ethics committee reference number
IR.IUMS.REC 1395.9211196251
Health conditions studied
1
Description of health condition studied
Burns and corrosions
ICD-10 code
T29, T31
ICD-10 code description
Burns and corrosions of multiple body regions, Burns classified according to extent of body surface involved
Primary outcomes
1
Description
The pain during burn dressing
Timepoint
Before and after dressing in the intervention group and control during three consecutive days
Method of measurement
Visual Analogue Scale (VAS)
2
Description
The anxiety during burn dressing
Timepoint
Before and after dressing in the intervention group and control during three consecutive days
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
NO
Timepoint
NO
Method of measurement
NO
Intervention groups
1
Description
Intervention group: This group will receive rhythmic breathing. subjects will be asked to sit in a comfortable semi -fowlers position in their beds and perform the following procedure for 20 minutes: (a) close your eyes (b) relax their muscles (c)breath slowly with a three-rhythm pattern of inhale, exhale, and rest, so that air from the nose and then slowly breathe out through your mouth (d) In all the time of breathing to increase the size of the chest, to move abdomen and his shoulders note Subjects' ability to use the technique will be verified by observing.
Category
Other
2
Description
Control group: No intervention will be performed
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi Educational Hospital Zanjan Province