Children with chronic diseases such as leukemia are subjected to pain during various procedures. Distraction is one of the easiest and least costly methods of non-pharmacological pain relief that has not been paid attention to by nurses. In the present study, the effectiveness of regular breathing method (hey-hu) in reduction of pain of intrathecal injection in leukemic children is evaluated. This study is conducted as a single blind randomized clinical trial among 100 patients coming to Shahid sadoughi Hospital, Yazd, Iran. The patients are 6-15 years old children coming to oncology ward suffering from leukemia. They are selected and randomly allocated to either regular breathing group or control group in equal numbers. The pain of children is assessed by Wong pain face scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012102311230N1
Registration date:2012-12-23, 1391/10/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-12-23, 1391/10/03
Registrant information
Name
Zahra Pourmovahed
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 1751
Email address
z_pourmovahed@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Expected recruitment start date
2010-10-12, 1389/07/20
Expected recruitment end date
2012-03-10, 1390/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Regular Breathing Technique (He-Hu) on Reduction of Intrathecal Injection Pain in Leukemic Children: A Randomized Clinical Trial
Public title
Effectiveness of Regular Breathing Technique (He-Hu) on Reduction of Intrathecal Injection Pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: alertness, verbal, subjective, visual and hearing ability; absence of pain and physiological needs (thirst, need for excretion….) before injection. The patients were 6-15 years old children coming to oncology ward suffering from leukemia. Exclusion criteria: Those patients who had a second injection were excluded from the study. We also excluded patients who had any respiratory difficulties.
Age
From 6 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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, Bahonar square
City
Yazd
Postal code
Approval date
2010-03-15, 1388/12/24
Ethics committee reference number
118120
Health conditions studied
1
Description of health condition studied
Blood cancer
ICD-10 code
C40-C41
ICD-10 code description
Malignant neoplasms of bone and articular cartilage
2
Description of health condition studied
Diseases of the blood
ICD-10 code
D50-D89
ICD-10 code description
Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism
Primary outcomes
1
Description
Pain
Timepoint
Imediately after intervention
Method of measurement
Wong pain face scale
Secondary outcomes
empty
Intervention groups
1
Description
The He-Hu technique was demonstrated to the subjects before injection in the study group which was as follows: The child was asked to initially inhale deeply and utter 'He; while exhaling. Then the child was asked to inhale deeply again and utter 'Hu' while exhaling. This method was practiced with the child in order to implement it accurately and was performed one minute before procedure till the end of the procedure. A respiratory rate of 20-30 per minute was considered for the children.
Category
Other
2
Description
There is not any intervention
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Zahra Pourmovahed
Street address
Shahid Sadoughi University of Medical Sciences, Bahonar square
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Fateme Ezadini Ardekani
Street address
Shahid Sadoughi University of Medical Sciences,Bahonar square
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
Zahra Pourmovahed
Position
master of sciences
Other areas of specialty/work
Street address
Nursing college, Shahid Sadoughi University of Medical Sciences
City
Yazd
Postal code
Phone
+98 35 1824 1751
Fax
Email
z_pourmovahed@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
Zahra Pourmovahed
Position
master of sciences
Other areas of specialty/work
Street address
Nursing college, Shahid Sadoughi University of Medical Sciences
City
Yazd
Postal code
Phone
+98 35 1824 1751
Fax
Email
z_pourmovahed@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
Zahra Pourmovahed
Position
master of sciences
Other areas of specialty/work
Street address
Nnursing college, Shahid Sadoughi University of Medical Sciences
City
Yazd
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)