Procedural PainNCT06541964
Two Different Distraction Methods for Reducing Procedural Pain in Children
A study testing Parent-Provide Distraction and Windmill Toy Blowing in people with Procedural Pain, run by Maltepe University at 1 site in Turkey (Türkiye).
Trial summary
This research will be carried out in a randomized controlled experimental design in order to study the effect of parent-provide distraction and windmill toy blowing methods in reducing the pain caused by blood collection in children aged 6-12 who have applied to the children's blood collection unit. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Procedural Pain
- What is being tested?
- Parent-Provide Distraction and Windmill Toy Blowing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2024to 13 Nov 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
- The children whose between 6 and 12 years old,
- The children does not have a visual, hearing or mental problem,
- The children and the parent's knowledge of Turkish at the level of the mother tongue,
- The voluntary consent of the children and his/her parent to participate in the research.
Who cannot join
- The children whose younger than 6 years and older than 12 years,
- The children have a visual, hearing or mental problem,
- The children and the parent's inability to speak Turkish at the level of their native language,
- The children and the parent do not agree to participate in the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Parent-Provide Distraction and Windmill Toy Blowing Methods on Pain During Venous Blood Collection in Children Aged 6-12 Years
This research will be carried out in a randomized controlled experimental design in order to study the effect of parent-provide distraction and windmill toy blowing methods in reducing the pain caused by blood collection in children aged 6-12 who have applied to the children's blood collection unit. It will be taken by randomization so that there is no bias in the people who will be included in the study. Randomization table "https://www.calculatorsoup.com " it was created using.
After randomization, the children in the parent-provide distraction group with parental participation will be asked riddles by the parent during the venous blood collection procedure. The children in the windmill toy blowing group will blow a windmill toy during the venous blood collection process. For the children in the control group, no distraction will be made during venous blood collection. As soon as the procedure is completed, the pain score during the procedure and the pain score will be evaluated one minute after the procedure. The evaluation will be made by the child, parent and nurse who draws blood.
Read the detailed description
Many different non-pharmacological methods are used to cope with adverse conditions such as pain caused by invasive procedures in children. One of these non-pharmacological methods is distraction. The American Pain Association recommends the use of distractions for pain control in children. By focusing the child's attention in another direction, the child's pain is controlled and reduced. As distraction methods, video games, virtual reality glasses, listening to music, watching cartoons, blowing balloons, reading books, blowing windmill toys, parent-provide distraction are used.
The aim of this study is to determine the effects of parent-provide distraction and windmill toy blowing in reducing pain during blood collection in children aged 6-12 years. Power analysis was performed to determine the number of people to be included in the research. The strength of the test was calculated using the G*Power 3.1 program. As a similar research in the relevant literature, the effect size of the difference in pain was calculated as 1.557 in the research conducted by Orhan (2020). In order to exceed the 95% value in determining the strength of the study, 51 people, including 17 people in groups with a significance level of 5% and an effect size of 1,557, must be reached (df=32; t=2,036). In the research, it was aimed to reach a total of 66 people, including 22 people in groups, taking into account the high strength of the test and the losses.
The Information Form, Wong Baker Faces Scale, VAS will be used for data collection. First of all, those who meet the criteria for inclusion in the research and research the purpose of the research will explain to the parents who volunteered to participate and their children by explaining the purpose of the research information about the research will be provided by the executor. Then about their participation in the study written and oral consent will be obtained from parents, and oral consent will be obtained from children. By obtaining information from the parent the information form will be filled out by the researcher before the blood collection procedure. Blood collection procedure it will be performed by a single experienced nurse Parental participation in the group of diverting attention information about the riddles will be provided by the researcher. By the research manager parents and children will be given information about the Wong Baker Faces Scale. Research manager children in the windmill toy blowing group will be supervised by blowing the windmill. No intervention will perform to reduce pain in the control group. In all groups, as soon as the procedure is completed and 1 minute after the procedure, the child's pain will be evaluated with the Wong Baker Faces Scale. The nurse and the parent will evaluate the child's pain with VAS. During the evaluation, pain assessments will be made in such a way that the child, parent and nurse will not see each other in order not to be affected by each other. It is estimated that the data collection process will take about 10-15 minutes.
- Conditions
- Procedural Pain
- Being tested
- Parent-Provide Distraction, Windmill Toy Blowing, Control
- Keywords
- Pain, Venous Blood Collection, Distraction
- Medical subject headings
- Pain, Procedural, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-Provide DistractionOther
The children will be asked riddles by their parents for 5 seconds before and during the blood collection procedure.
Windmill Toy BlowingOther
The children will blow on the windmill toy for 5 seconds before and during the blood collection procedure.
ControlOther
No intervention will make on the children.
| Study group | Role | What they receive |
|---|---|---|
| Parent-Provide Distraction Group | Experimental | Parent-Provide Distraction Group Receives: Other: Parent-Provide Distraction |
| Windmill Toy Blowing Group | Experimental | Windmill Toy Blowing Group Receives: Other: Windmill Toy Blowing |
| Control Group | Other | Control Group Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Evaluated by Children (Wong-Baker Faces Scale)
Pain will be assessed by children with Wong-Baker Faces Scale. It is a valid and safe individual notification-based scale used to describe pain in children aged 3-18 (Wong-Baker Faces Foundation-http://wongbakerfaces.org/). It consists of 6 facial expressions ranging from smiling face to crying facial expression, which are scored Dec Decently from 0 to 10 to describe the severity of pain. As the score obtained from the scale increases, the severity of pain increases, and the severity decreases as the score decreases. "Face 0" means that there is no pain. He has a smiley face expression. "Face 2" has a little pain. "Face 4 " has a little more pain. There are more than "face 6" pain. The "face 8" pain is quite a lot. The pain of "face 10" is unbearable. The severity of the pain can be defined by enabling children to choose the shape of the face from the expression of their pain.
Measured: During venipuncture procedure (when needle insertion and the first blood was seen in injector, until needle removed), and one minute after venipuncture procedure (one minute after the injector was removed)
Secondary outcomes (1)
Pain Evaluated by Parents and Nurse (Visual Analog Scale)
Pain will be assessed by parents and nurse with Visual Analog Scale. The scale developed by Freyd was used to determine the severity of pain. VAS is the scaled version of a 10-centimeter line from 1 to 10. a value of 10 indicates maximum pain, while a value of 0 means that there is no pain at all. He is asked to mark the appropriate place on the scale according to the level of pain. The pain score is determined by measuring with a ruler. This scale is a safe and widely used measurement tool accepted in the literature.
Measured: During venipuncture procedure (when needle insertion and the first blood was seen in injector, until needle removed), and one minute after venipuncture procedure (one minute after the injector was removed)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start30 Aug 2024
- Primary completion13 Nov 2024
- Study completion13 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Erkut, Maltepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541964
- Sponsor's protocol ID
- 2024/12-05
- Status last verified
- Nov 2024
- First submitted
- 3 Aug 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Parent-Provide Distraction and Windmill Toy Blowing Methods on Pain During Venous Blood Collection in Children Aged 6-12 Years
- ClinicalTrials.gov ID
- NCT06541964
- Acronym / sponsor ID
- 2024/12-05
- Conditions
- Procedural Pain
- Keywords
- Pain, Venous Blood Collection, Distraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- 13 Nov 2024 (actual)
- First posted
- 7 Aug 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 research will be carried out in a randomized controlled experimental design in order to study the effect of parent-provide distraction and windmill toy blowing methods in reducing the pain caused by blood collection in children aged 6-12 who have applied to the children's blood collection unit. It will be taken by randomization so that there is no bias in the people who will be included in the study. Randomization table "https://www.calculatorsoup.com " it was created using.
After randomization, the children in the parent-provide distraction group with parental participation will be asked riddles by the parent during the venous blood collection procedure. The children in the windmill toy blowing group will blow a windmill toy during the venous blood collection process. For the children in the control group, no distraction will be made during venous blood collection. As soon as the procedure is completed, the pain score during the procedure and the pain score will be evaluated one minute after the procedure. The evaluation will be made by the child, parent and nurse who draws blood.
Detailed description
Many different non-pharmacological methods are used to cope with adverse conditions such as pain caused by invasive procedures in children. One of these non-pharmacological methods is distraction. The American Pain Association recommends the use of distractions for pain control in children. By focusing the child's attention in another direction, the child's pain is controlled and reduced. As distraction methods, video games, virtual reality glasses, listening to music, watching cartoons, blowing balloons, reading books, blowing windmill toys, parent-provide distraction are used.
The aim of this study is to determine the effects of parent-provide distraction and windmill toy blowing in reducing pain during blood collection in children aged 6-12 years. Power analysis was performed to determine the number of people to be included in the research. The strength of the test was calculated using the G*Power 3.1 program. As a similar research in the relevant literature, the effect size of the difference in pain was calculated as 1.557 in the research conducted by Orhan (2020). In order to exceed the 95% value in determining the strength of the study, 51 people, including 17 people in groups with a significance level of 5% and an effect size of 1,557, must be reached (df=32; t=2,036). In the research, it was aimed to reach a total of 66 people, including 22 people in groups, taking into account the high strength of the test and the losses.
The Information Form, Wong Baker Faces Scale, VAS will be used for data collection. First of all, those who meet the criteria for inclusion in the research and research the purpose of the research will explain to the parents who volunteered to participate and their children by explaining the purpose of the research information about the research will be provided by the executor. Then about their participation in the study written and oral consent will be obtained from parents, and oral consent will be obtained from children. By obtaining information from the parent the information form will be filled out by the researcher before the blood collection procedure. Blood collection procedure it will be performed by a single experienced nurse Parental participation in the group of diverting attention information about the riddles will be provided by the researcher. By the research manager parents and children will be given information about the Wong Baker Faces Scale. Research manager children in the windmill toy blowing group will be supervised by blowing the windmill. No intervention will perform to reduce pain in the control group. In all groups, as soon as the procedure is completed and 1 minute after the procedure, the child's pain will be evaluated with the Wong Baker Faces Scale. The nurse and the parent will evaluate the child's pain with VAS. During the evaluation, pain assessments will be made in such a way that the child, parent and nurse will not see each other in order not to be affected by each other. It is estimated that the data collection process will take about 10-15 minutes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parent-Provide Distraction Group | Experimental | Other: Parent-Provide DistractionParent-Provide Distraction Group |
| Windmill Toy Blowing Group | Experimental | Other: Windmill Toy BlowingWindmill Toy Blowing Group |
| Control Group | Other | Other: ControlControl Group |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The children whose between 6 and 12 years old,
- The children does not have a visual, hearing or mental problem,
- The children and the parent's knowledge of Turkish at the level of the mother tongue,
- The voluntary consent of the children and his/her parent to participate in the research.
Key exclusion criteria (4 listed)
- The children whose younger than 6 years and older than 12 years,
- The children have a visual, hearing or mental problem,
- The children and the parent's inability to speak Turkish at the level of their native language,
- The children and the parent do not agree to participate in the research.
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 |
|---|---|---|
| Parent-Provide DistractionThe children will be asked riddles by their parents for 5 seconds before and during the blood collection procedure. | Other | Parent-Provide Distraction Group |
| Windmill Toy BlowingThe children will blow on the windmill toy for 5 seconds before and during the blood collection procedure. | Other | Windmill Toy Blowing Group |
| ControlNo intervention will make on the children. | Other | Control Group |
Primary outcome
Pain Evaluated by Children (Wong-Baker Faces Scale)
Time frame: During venipuncture procedure (when needle insertion and the first blood was seen in injector, until needle removed), and one minute after venipuncture procedure (one minute after the injector was removed)
Pain will be assessed by children with Wong-Baker Faces Scale. It is a valid and safe individual notification-based scale used to describe pain in children aged 3-18 (Wong-Baker Faces Foundation-http://wongbakerfaces.org/). It consists of 6 facial expressions ranging from smiling face to crying facial expression, which are scored Dec Decently from 0 to 10 to describe the severity of pain. As the score obtained from the scale increases, the severity of pain increases, and the severity decreases as the score decreases. "Face 0" means that there is no pain. He has a smiley face expression. "Face 2" has a little pain. "Face 4 " has a little more pain. There are more than "face 6" pain. The "face 8" pain is quite a lot. The pain of "face 10" is unbearable. The severity of the pain can be defined by enabling children to choose the shape of the face from the expression of their pain.
1 secondary outcome
Pain Evaluated by Parents and Nurse (Visual Analog Scale)
Time frame: During venipuncture procedure (when needle insertion and the first blood was seen in injector, until needle removed), and one minute after venipuncture procedure (one minute after the injector was removed)
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 15 Nov 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-Provide Distraction and Windmill Toy Blowing in people with Procedural Pain, run by Maltepe 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 15 Nov 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?
Pain Evaluated by Children (Wong-Baker Faces Scale) (time frame: During venipuncture procedure (when needle insertion and the first blood was seen in injector, until needle removed), and one minute after venipuncture procedure (one minute after the injector was removed)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2024.