Protocol summary

Summary
The Purpose Of This Study Is To Examine The Effect Of Deep – Slow And Regular Breathing On Pain Intensity Of Burn Dressing. The Indus ion Criteria Are 10-25% Of The Whole Body Burn , Second Degree Burn , Ability To Speak , Being In The Acute Phase Of Burn Injury (48-72 Hours After Burning ): And The Exclusion Criteria Are Lack Of Face And Neck Burn , Lack Of Numbness In The Burnt Argons , Lack Of Severe Hearing Or Vision Problems . This Is A Clinical Trial Study Conducted On Adult Male Patients Hospitalized In The Burn Ward Of Educational Ayatollah Kashani Hospital Of Shahrekord. In Each Group, 34 Patients Are Enrolled (Based On Type I Error and 0.05 And 0.9 Square). Thus 68 Patients Are Selected By Convenience Sampling And Randomly Assigned To Intervention And Control Groups. The Two Groups Are Matched By Age, Educational Level, And Addiction To Drugs Or Psychotropic Medications. The Intervention Group Recieves Deep Slow And Regular Breathing And Training On How To Perform It, And The Control Group Receives No Training. The Exected Outcome Is A Reduction In Pain During Doing Dressing, Assessed By Visual Analogue Scale 15-45 Minutes After Dressing. The Data Are Gathered By Visial Analogue Scale And Analyzed By Spss Software Using Independent Test.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201307016973N4
Registration date: 2013-10-03, 1392/07/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-10-03, 1392/07/11
Registrant information
Name
Hedayat Allah Lalegani
Name of organization / entity
Shahrekord University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 38 1338 7386
Email address
lalegani@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Science
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of the effect of deep- slow and regular breathing on pain intensity of burn dressing
Public title
The study of the effect of deep- slow and regular breathing on pain intensity of burn dressing
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients will be selected from ones whose bodies are burnt only 25 to 10 percent, their burn is the second degree, able to speak, be in the acute phase of burn injury (72-48 hours after burn). Exclusion criteria: Participants have face and neck burns, have the known mental disorders in the past or present, have neurological disorders and numbness in the burnt organs, and Participants have the severe hearing or vision problems.
Age
From 18 years old to 70 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 68
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
Shahrekord University of Medical Science
Street address
Shahrekord University of Medical Science
City
Shahrekord
Postal code
Approval date
2012-08-19, 1391/05/29
Ethics committee reference number
1391-05-71-1640

Health conditions studied

1

Description of health condition studied
borning
ICD-10 code
S00-T98
ICD-10 code description
Diseases of the skin and subcutaneous tissue

Primary outcomes

1

Description
pain intensity
Timepoint
15 until 45 minutes after born dressing
Method of measurement
Visual analogue scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Education of deep- slow and discipline breathing before than born dressing.
Category
Other

2

Description
Control group: did not receive any education or intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahrekord University of Medical Science Ayatallah Kashani Hospita
Full name of responsible person
Hedayat allah Lalehgani
Street address
Shahrekord University of Medical Science
City
shahrekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahrekord University of Mrdical Science Shahrekord
Full name of responsible person
Hedayat allah Lalehgani
Street address
Shahrekord University of Medical Science Ayatallah Kashani Hospital
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord University of Mrdical Science Shahrekord
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
Shahrekord University of Medical Science
Full name of responsible person
Hedayatallah Lalehgani
Position
Ms in Nursing
Other areas of specialty/work
Street address
Shahrekord University of Medical Science
City
Shahrekord
Postal code
Phone
+98 38 1222 8600
Fax
Email
lalegani@skums.ac.irlalehganihedayat@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrekord University of Medical Science
Full name of responsible person
Hedayatallah Lalehgani
Position
Ms in Nursing
Other areas of specialty/work
Street address
Shahrekord University of Medical Science
City
Shahrekord
Postal code
Phone
+98 38 1222 8600
Fax
Email
lalegani@skums.ac.irlalehganihedayat@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahrekord University of Medical Science
Full name of responsible person
Hedayatallah Lalehgani
Position
Ms in Nursing
Other areas of specialty/work
Street address
Shahrekord University of Medical Science
City
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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