Objective: we conducted this study to investigate the efficacy of holding and pressing the tip of the nose on the venipuncture pain reduction in the pediatric patients who were undergoing tonsillectomy under general anesthesia.
The study design was prospective randomized control while, Population was calculated 60 patients between 6-12 yr.
Inclusion criteria: 6-12 years old children who were undergoing tonsillectomy under general anesthesia.
Exclusion criteria: cardiac or neurological impairment; history of difficulty in communication ; difficulty in venous-puncture (more than one attempt); patients with skin diseases at or around the VP site, such as scars; infection; psoriasis; eczema; active dermatitis, etc.
Intervention: Patients were divided in to two groups of 30 each before cannulation: the control and the study group. Nasal tip was held and pressed during veni-puncture by the parents in the study group. No intervention was done in the control group. Visual Analogue Scale (VAS) was used for assessment of cannulation pain and the Yale Preoperative Anxiety Scale (YPAS) was used for the assessment of anxiety before cannulation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016031019470N31
Registration date:2016-04-05, 1395/01/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-05, 1395/01/17
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shiraz University of Medical Science
Expected recruitment start date
2016-01-20, 1394/10/30
Expected recruitment end date
2016-08-21, 1395/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of Nasal Tip Hold_ press on Venous Cannulation Pain in Children
Public title
The efficacy of Nasal Tip Hold_ press on Venous Cannulation Pain in Children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 6-12 years old children who were undergoing tonsillectomy under general anesthesia.
Exclusion criteria: cardiac or neurological impairment; history of difficulty in communication ; difficulty in venous-puncture (more than one attempt); patients with skin diseases at or around the VP site, such as scars; infection; psoriasis; eczema; active dermatitis, etc.
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiaz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
Ir.sums.rec.1394.213
Health conditions studied
1
Description of health condition studied
Tonsillitis
ICD-10 code
J03
ICD-10 code description
Acute Tonsillitis
Primary outcomes
1
Description
pain
Timepoint
before cannulation
Method of measurement
Visual analogue scale (VAS)
2
Description
anxiety
Timepoint
before cannulation
Method of measurement
Yale preoperative anxiety scale (YPAS)
Secondary outcomes
empty
Intervention groups
1
Description
Nasal tip was held and pressed during veni-puncture by the parents in the study group
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalili Hospital
Full name of responsible person
Dr Behzad Maghsodi
Street address
Khalili Street, Khalili Hospital
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiaz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences ,Zand streetl
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Shiaz 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
Shiraz University of Medical Sciences
Full name of responsible person
Behzad Maghsodi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Anesthesiology Department- Faghihi Hospital- Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
maghsodb@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Behzad Maghsodi
Position
Anesthesilogist
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
00
Fax
Email
maghsodb@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz anesthesiology and critical care research center
Full name of responsible person
Farzaneh Masihi
Position
English Consultant
Other areas of specialty/work
Street address
Shiraz Anesthesiology and Critical Care Research Center, Research Tower, 5 th floor, Khalili street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
masihifarzaneh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)