Child DevelopmentNCT06230601
Effect of Cough Trick Method and Pinwheel Blowing in Blood Collection
A study testing Cough Trick Method and Pinwheel Blowing method in people with Child Development and Nursing Care, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
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.The study will be conducted with children aged 6-12 years who are subjected to blood tests by a pediatrician."Descriptive Questionnaire", "Visual Analogue Scale… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Development, Nursing Care, Pain
- What is being tested?
- Cough Trick Method and Pinwheel Blowing method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2024to 15 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Cough Trick Method and Pinwheel Blowing in Blood Collection in School-Age Children on the Level of Pain: Randomized Controlled 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.The study will be conducted with children aged 6-12 years who are subjected to blood tests by a pediatrician."Descriptive Questionnaire", "Visual Analogue Scale (VAS)", "FLACC Pain Rating Scale" and "Wong-Baker Faces Pain Rating Scale (WBFPRS)" will be used to collect data.The data will be uploaded to the computer and coded by the researchers, and the data will be evaluated in the SPSS package program.The sociodemographic data of the children participating in the study will be given as numbers and percentage distributions. Appropriate tests will be used by analyzing the data for normal distribution. 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.
Read the 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.
- Conditions
- Child Development, Nursing Care, Pain
- Being tested
- Cough Trick Method, Pinwheel Blowing method
- Keywords
- children, nurse, blood collection, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cough Trick MethodOther
Also called Pinwheel Blowing Method
During the Blood Collection Procedure in School-Age Children, one group will use the Cough Trick Method
Pinwheel Blowing methodOther
Pinwheel Blowing method
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | cough trick method will be used in the blood collection process from the children in the experimental group. Receives: Other: Cough Trick Method |
| Active comprator | Active comparator | Pinwheel Blowing method will be used in the blood collection process from the children in the experimental group. Receives: Other: Pinwheel Blowing method |
| control group | No intervention | Routine application of the unit will be made |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Scale
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start10 Feb 2024
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Selime MERTER, Firat University
- Investigators
- Zeynep KİSECİK ŞENGÜL, Study chair, Kirikkale UniverstyRüveyda OĞUZ, Study chair, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230601
- Sponsor's protocol ID
- 2024/ 01-50
- Status last verified
- Jul 2024
- First submitted
- 21 Jan 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Merter OS, Sengul ZK, Oguz R. Effects of blowing pinwheel and cough trick on pain in 6- to 12-year-old children during venipuncture: A randomized controlled trial. J Pediatr Nurs. 2025 Jul-Aug;83:30-37. doi: 10.1016/j.pedn.2025.04.023. Epub 2025 Apr 24.
PubMed 40279824
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cough Trick Method and Pinwheel Blowing in Blood Collection in School-Age Children on the Level of Pain: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06230601
- Acronym / sponsor ID
- 2024/ 01-50
- Conditions
- Child Development, Nursing Care, Pain
- Keywords
- children, nurse, blood collection, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 10 Feb 2024 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.The study will be conducted with children aged 6-12 years who are subjected to blood tests by a pediatrician."Descriptive Questionnaire", "Visual Analogue Scale (VAS)", "FLACC Pain Rating Scale" and "Wong-Baker Faces Pain Rating Scale (WBFPRS)" will be used to collect data.The data will be uploaded to the computer and coded by the researchers, and the data will be evaluated in the SPSS package program.The sociodemographic data of the children participating in the study will be given as numbers and percentage distributions. Appropriate tests will be used by analyzing the data for normal distribution. 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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: Cough Trick Methodcough trick method will be used in the blood collection process from the children in the experimental group. |
| Active comprator | Active comparator | Other: Pinwheel Blowing methodPinwheel Blowing method will be used in the blood collection process from the children in the experimental group. |
| control group | No intervention | –Routine application of the unit will be made |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cough Trick MethodAlso: Pinwheel Blowing MethodDuring the Blood Collection Procedure in School-Age Children, one group will use the Cough Trick Method | Other | experimental group |
| Pinwheel Blowing methodPinwheel Blowing method | Other | Active comprator |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Derived from this study: PubMed 40279824Merter OS, Sengul ZK, Oguz R. Effects of blowing pinwheel and cough trick on pain in 6- to 12-year-old children during venipuncture: A randomized controlled trial. J Pediatr Nurs. 2025 Jul-Aug;83:30-37. doi: 10.1016/j.pedn.2025.04.023. Epub 2025 Apr 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeynep KİSECİK ŞENGÜL study chair
Kirikkale Universty
Rüveyda OĞUZ study chair
Firat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cough Trick Method and Pinwheel Blowing method in people with Child Development and Nursing Care, run by Firat University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Pain Scale (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06230601, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.