- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07654192
The Effect of ShotBlocker and Finger Puppet on Pain and Fear During Blood Drawing in Children
The Effect of ShotBlocker and Finger Puppet on Pain and Fear During Blood Drawing in Children: A Randomized Controlled Trial
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Bolu, Turcja (Türkiye)
- Abant Izzet Baysal University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Being between 5 and 10 years old
- Not having chronic pain
- Not using sedative/anticonvulsant/analgesic medication
- Not having a mental or neurological disability
- Blood collection should be performed by the same nurse
Exclusion Criteria:
- Having chronic pain
- Using sedative/anticonvulsant/analgesic medication
- Having a mental or neurological disability
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: Shotblocker Group
Shotblocker is administered to children during the blood sampling collection process.
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Distraction techniques such as Shotblocker, which are among non-pharmacological methods, are used to reduce pain, fear, and anxiety by diverting attention away from pain and directing it toward another interesting stimulus. Once the children in the Shotblocker group sit down in the blood draw chair, the specified procedure will be applied before the blood drawing begins.
Distraction techniques such as Finger Puppet, which are among non-pharmacological methods, are used to reduce pain, fear, and anxiety by diverting attention away from pain and directing it toward another interesting stimulus.
Once the children in the Finger Puppet group sit down in the blood draw chair, the specified procedure will be applied before the blood drawing begins.
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Aktywny komparator: Finger Puppet Group
Finger Puppet is administered to children during the blood sampling collection process.
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Distraction techniques such as Shotblocker, which are among non-pharmacological methods, are used to reduce pain, fear, and anxiety by diverting attention away from pain and directing it toward another interesting stimulus. Once the children in the Shotblocker group sit down in the blood draw chair, the specified procedure will be applied before the blood drawing begins.
Distraction techniques such as Finger Puppet, which are among non-pharmacological methods, are used to reduce pain, fear, and anxiety by diverting attention away from pain and directing it toward another interesting stimulus.
Once the children in the Finger Puppet group sit down in the blood draw chair, the specified procedure will be applied before the blood drawing begins.
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Brak interwencji: Control Group
No intervention is performed on the control group during the blood sampling collection process.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Primary Outcome Measure
Ramy czasowe: Time frame is up to 12 moths. From October 01 2025 to October 01 2026.
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The aim of this study is to evaluate the effectiveness of ShotBlocker and finger puppets in reducing pain and fear in children aged 5-10 years during blood sapmling in the pediatric blood collection unit. On the child fear scale, "0" indicates no fear; "4" indicates the highest level of fear. It consists of facial expressions ranging from 0, indicating no pain, to 10, representing severe pain. Data collection takes no more than 10 minutes. |
Time frame is up to 12 moths. From October 01 2025 to October 01 2026.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Randomization
Ramy czasowe: Time frame is up to 15 minutes.
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Randomization in the study has been done with using a computer program (https://www.randomizer.org). To determine which children would be in the intervention and control groups, children with numbers from 1 to 90 were entered into the computer program without repetition. To avoid bias in randomisation and to increase reliability, the assignment to the intervention and control groups was made by an independent statistician. All blood collection procedures will be performed by the same nurse. A nurse with a four-year nursing diploma working in the same blood collection unit will serve as an independent observer. The observer will evaluate the children in the experimental and control groups. |
Time frame is up to 15 minutes.
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Data Collection Tools
Ramy czasowe: Time frame is up to 15 minutes.
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In data collection, interview and observation form created by researchers (child's age, gender, previous blood sampling experience, etc.), the Children's Fear Scale, and the Wong-Baker FACES Pain Rating Scale will be used for all groups.
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Time frame is up to 15 minutes.
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Children's Fear Scale (CFS)
Ramy czasowe: Time frame is up to 10 minutes.
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This scale is rating from 0 to 4 with five drawn facial expressions representing a range from a neutral expression (0 = no fear) to a frightened face (4 = extreme fear).
It may be used by parents and researchers before and during the procedure for children.
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Time frame is up to 10 minutes.
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Wong-Baker FACES (WB-FACES) Pain Rating Scale
Ramy czasowe: Time frame is up to 10 minutes.
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This scale is used to rate pain in children aged 3 years and older.
The scale consists of facial expressions ranging from 0, indicating no pain, to 10, representing severe pain.
Children are asked to select the facial expression that most accurately reflects the intensity of their pain, and then a score is assigned.
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Time frame is up to 10 minutes.
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ShotBlocker
Ramy czasowe: Time frame is up to 5 minutes.
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ShotBlocker was used on children in the ShotBlocker group during blood sampling.
ShotBlocker device (Bionix LLC, Maumee, Ohio, USA) is a drug-free, flexible, and U-shaped, non-invasive plastic apparatus with small protrusions.
It is placed directly on the skin and has a slit in the middle for inserting the needle.
It is pressed firmly onto the skin, and the blunt contact points provide painless physical stimulation.
This blocks the perception of pain caused by needle insertion, which is consistent with the "gate control" theory of pain.
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Time frame is up to 5 minutes.
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Finger Puppet
Ramy czasowe: Time frame is up to 5 minutes.
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Finger puppets were used on children in the finger puppet group during blood sampling.
Finger puppets consist of plush toys featuring various animal figures that can be worn on adults' fingers.
The researcher put on the finger puppet chosen by the child and spoke to the child by imitating animal sounds.
After the intervention, finger puppets were given as gifts to the children who wanted them.
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Time frame is up to 5 minutes.
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Data Collection
Ramy czasowe: Time frame is up to 15 minutes.
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The same nurse will perform the blood collection procedure on the children.
A nurse with a four-year nursing degree working in the same blood collection unit will become an independent observer.
The observer will assess the pain and fears of the children in the experimental and control groups using scales.
The researcher will give the interview and observation form to the parent to fill out before the blood drawing.
The child's level of fear regarding the procedure will be recorded using the CFS by asking separate questions to the child, parent, and observer before the procedure.
The child's fear of the procedure and pain will be separately assessed and recorded by the child, parent, and observer after the procedure.
The child, parent, and observer independently and simultaneously evaluated the scales will be used.
The ShotBlocker and finger puppet will be administered to the children in the experimental groups by the same researcher.
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Time frame is up to 15 minutes.
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Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- AIBU-SBF-CC-01
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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Badania kliniczne na Distraction techniques
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