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Two Different Therapeutic Interventions Applied During Blood Sampling in Children

3 września 2026 zaktualizowane przez: Eda Gulbetekin, Igdir University

The Effect of Two Different Therapeutic Interventions on Pain, Anxiety and Fear During Venipuncture in Children

This research is a three-group, randomized controlled experimental study designed to determine the effect of two different therapeutic interventions applied during blood sampling on pain, anxiety, and fear levels in children aged 5-7 years.

Children participating in the study will be randomly divided into three groups:

  1. Group (Experiment 1): Distraction method using betta fish observation
  2. Group (Experiment 2): Distraction method using hand puppets
  3. Group (Control): Routine clinical practice (without any therapeutic intervention) Before, during, and after blood sampling, children's pain level (FLACC scale), fear level (child fear scale), and anxiety level (child anxiety scale) will be evaluated.

Przegląd badań

Szczegółowy opis

This research is a three-group, randomized controlled experimental study designed to determine the effect of two different therapeutic interventions applied during blood sampling on pain, anxiety, and fear levels in children aged 5-7 years.

Children participating in the study will be randomly divided into three groups:

  1. Group (Experiment 1): Distraction method using betta fish observation
  2. Group (Experiment 2): Distraction method using hand puppets
  3. Group (Control): Routine clinical practice (without any therapeutic intervention) Before, during, and after blood sampling, children's pain level (FLACC scale), fear level (child fear scale), and anxiety level (child anxiety scale) will be evaluated.

The obtained data will be compared using statistical analysis methods. The population of the study will consist of children aged 5-7 years who apply to the Pediatric Emergency Unit of Iğdır Dr. Nevruz Erez State Hospital and undergo venous blood sampling. The sample of the study will consist of children and their parents who meet the inclusion criteria and voluntarily agree to participate in the study. Children selected using an appropriate sampling method will be randomly assigned to three groups.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

105

Faza

  • Faza 1

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko

Akceptuje zdrowych ochotników

Tak

Opis

Inclusion Criteria:

  • Being between 5 and 7 years old,
  • Having a scheduled venous blood sampling procedure in the Pediatric Emergency Unit,
  • Having a level of consciousness suitable for communication,
  • The child and their parents agreeing to participate in the study,
  • Being able to communicate in Turkish.

Exclusion Criteria:

Inability to participate in the application due to visual or hearing problems,

  • Inability to administer the scales due to a developmental or neurological disease,
  • Being under the influence of sedative or analgesic medication,
  • Inability to complete the application during the research process,
  • Lack of parental consent.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Experimental: experimental group

Distraction method using betta fish observation Participation in the study is entirely voluntary. After the purpose of the study is explained to the experimental group by the researcher and written and verbal permission is obtained from those who voluntarily agree to participate in the study, the pre-test data will be collected by the researcher.

355 This research is a carefully planned, three-group, randomized controlled study designed to determine the levels of pain, anxiety, and fear experienced by children aged 5-7 years during blood sampling using two different therapeutic interventions. The working children will be randomly assigned to three groups: Group 1 (Experiment 1): Distraction method using betta fish observation

Before, during, and after blood sampling, the children's pain level (FLACC scale), fear level (child fear scale), and anxiety level (child anxiety scale) will be assessed.

The obtained data will be compared using statistical analysis methods. Group 1 (Experiment 1): Distraction method using betta fish observation

Eksperymentalny: Experimental: experimental 2 group
Hand puppet distraction method This research is a carefully planned, three-group, randomized controlled study designed to determine the levels of pain, anxiety, and fear experienced by children aged 5-7 years during blood sampling with two different therapeutic interventions. The working children will be randomly assigned to three groups: Group 2 (Experiment 2): Hand puppet distraction method

Before, during, and after blood sampling, the children's pain level (FLACC scale), fear level (child fear scale), and anxiety level (child anxiety scale) will be assessed.

The obtained data will be compared using statistical analysis methods. Group 2 (Experiment 2): Distraction method using hand puppets

Eksperymentalny: Experimental: Experimental: Control Group

Standart of care This research is a carefully planned, three-group, randomized controlled trial to determine the levels of pain, anxiety, and fear experienced by children aged 5-7 years during blood sampling with two different therapeutic interventions.

The working children will be randomly assigned to three groups:

Group 3 (Control): Routine clinical practice (without any therapeutic intervention)

Before, during, and after blood sampling, the children's pain level (FLACC scale), fear level (child fear scale), and anxiety level (child anxiety scale) will be assessed.

The obtained data will be compared using statistical analysis methods. Group 3 (Control): Routine clinical practice (without any therapeutic intervention)

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
FLACC Pain Assessment Scale
Ramy czasowe: through study completion, an average of 1 year
This scale is a pain scale assess pain in children aged 2 months to 7 years.It evaluates leg movements, facial expression, crying, and soothing ability and activity behaviors in relation to the pain experienced by the child. These behaviors are scored using a scale of 0, 1, and 2 points. A score of '0' indicates the absence of pain, '1-3' indicates mild pain, '4-6' indicates moderate pain, and '7-10' indicates the presence of severe pain.
through study completion, an average of 1 year
Children's Fear Scale
Ramy czasowe: through study completion, an average of 1 year

The scale is designed for children aged 5 to 10 years. A talented graphic artist developed visual depictions showing changes in facial muscles associated with fear, using photographs of individuals with anxious facial expressions.

The scale can be used by parents, children, or researchers to assess children's fear levels. The child is presented with a scale consisting of five facial expressions, each scored between "0" and "4". A score of "0" indicates a fearless, neutral expression, while "4" represents the highest level of fear. The scores progress as follows: "0" (neutral statement/no fear), "1" (very little fear), "2" (some fear), "3" (more fear) and "4" (highest possible fear). This scale can be used to measure fear both before and during the procedure.

through study completion, an average of 1 year
Child Anxiety Scale
Ramy czasowe: through study completion, an average of 1 year
The "Child Anxiety Scale-State (CAS-S)," which resembles a thermometer with horizontal lines, is scored from 0 to 10. It is a scale developed for children aged 4-10 years. When the scale is introduced to the child, it is stated that there is no anxiety, that anxiety increases as the scale moves upwards, and that the anxiety level is very high at the top. Then, the child is asked to indicate the level of anxiety or tension they feel with a line. The scale, developed by Ersig et al. (Ersig et al., 2013) in 2013, had its Turkish validity and reliability study conducted by Gerçeker et al. in 2018 (Gerçeker et al., 2018). The "Child Anxiety Scale-State (CAS-S)," which resembles a thermometer with horizontal lines, is scored from 0 to 10. It is a scale developed for children aged 4-10 years.
through study completion, an average of 1 year

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 sierpnia 2026

Zakończenie podstawowe (Szacowany)

1 września 2026

Ukończenie studiów (Szacowany)

1 grudnia 2026

Daty rejestracji na studia

Pierwszy przesłany

23 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

23 lipca 2026

Pierwszy wysłany (Rzeczywisty)

28 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

9 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

3 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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