- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06230601
Effect of Cough Trick Method and Pinwheel Blowing in Blood Collection
Effect of Cough Trick Method and Pinwheel Blowing in Blood Collection in School-Age Children on the Level of Pain: Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Purpose of the study: This study aimed to examine the effect of the cough trick method and pinwheel blowing on the severity of pain during blood collection in school-age children.
Type of Study: It is a randomized controlled study.
Location and Characteristics of the Study: It will be conducted in the pediatric blood collection unit of Fırat University Hospital, with children aged 6-12 who are subjected to blood tests by a pediatrician.
Population-Sample: The population of the study will consist of children who applied for blood collection in the pediatric blood collection unit of Fırat University Hospital. A pilot study will be conducted to determine the number of samples. For the pilot study, 20 participants will be taken from each group and a total of 60 samples will be taken. As a result of the pilot study, power analysis will be performed and the number of samples will be determined. Randomization will be done to assign the participants to the groups. Grouping will be done using simple random sampling. Randomization will be provided using the Random Sequence Generator on the www.random.org website. Each participant who volunteers to participate in the study and meets the criteria will be given a number. Accordingly, which number will take place in which group will be determined in advance.
Data collection tools: Questionnaire", "Visual Analogue Scale (VAS)", "FLACC Pain Rating Scale" and "Wong-Baker Faces Pain Rating Scale (WBFPRS)" will be used to collect data.
Data Collection: The research will be carried out in three stages. Stage 1: Groups of parent-child pairs who come to the blood collection unit, voluntarily participate in the research, and meet the inclusion criteria will be determined in line with the randomization method within the scope of the research. Study data will be collected in 3 groups. Two groups will be the intervention group and the third group will be the control group.
Group 1: cough trick group 2nd group is the pinwheel blower group. Group 3 will constitute the control group. Stage 2: Information about the children assigned to the groups will be obtained using the "Introductory Question Form".
Stage 3: Blood collection will be performed by the same nurse (a volunteer nurse with 5 years of experience in pediatric blood collection) to eliminate differences that may occur due to nurse differences. Blood samples from children will be taken with a 21 gauge x 1.5 inch vacuum blood collection needle. It will be ensured that the parent accompanies the child throughout all procedures.
Pain intensity will be measured through observation and physiological responses of the child, parent, and nurse. The child's pain intensity will be rated by the parent, the nurse (a pediatric nurse with 5 years of experience, independent of the blood draw) and the child himself before and after the blood draw. To determine pain severity, parents will use VAS, the nurse will use FLACC, and the child will use FACES scale.
Heart rate is the physiological measure used to report pain intensity, and the heart rate of the children in the study will be recorded before and after the procedure using a pulse oximeter device at 2-minute intervals. The demographic questionnaire will be filled out by the children's parents 10 minutes before the procedure.
The statistical significance level of the study was determined as p< 0.05. In addition, at the end of the research, the status of working with sufficient sample size will be tested with post-hoc power analysis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Elazığ, Turkey
- Fırat Univesity
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- School age children ages 6-12.
- Peripheral intravenous catheter (PIC) application was performed by the same nurse (with at least 5 years of experience).
- Able to express himself/herself verbally
- No visual or auditory problems
Exclusion Criteria:
- Children who received tropical anesthetic before the procedure
- Children whose first attempt to draw blood was unsuccessful
- Children who have taken analgesic medication within 24 hours before blood sampling
- Children with a body temperature of 37.5 ºC and above, mental or neurological disorders, a medical history of fainting or chronic diseases requiring frequent blood sampling, and those who have previously undergone surgery will be excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental group
cough trick method will be used in the blood collection process from the children in the experimental group.
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During the Blood Collection Procedure in School-Age Children, one group will use the Cough Trick Method
Other Names:
|
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Active Comparator: Active comprator
Pinwheel Blowing method will be used in the blood collection process from the children in the experimental group.
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Pinwheel Blowing method
|
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No Intervention: control group
Routine application of the unit will be made
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numerical Pain Scale
Time Frame: 1 day
|
This method, which is aimed at determining the severity of pain, aims to explain the patient's pain in numbers.
Absence of pain (0) is evaluated as unbearable pain (10) on numerical scales.
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1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Zeynep KİSECİK ŞENGÜL, Kirikkale Universty
- Study Chair: Rüveyda OĞUZ, Firat University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2024/ 01-50
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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