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The Effect of ShotBlocker and Finger Puppet on Pain and Fear During Blood Drawing in Children

2026년 6월 12일 업데이트: Çiğdem Ceylan, Abant Izzet Baysal University

The Effect of ShotBlocker and Finger Puppet on Pain and Fear During Blood Drawing in Children: A Randomized Controlled Trial

Blood sampling can cause pain, anxiety, and fear in children. Such negative experiences may cause the child to develop negative attitudes toward treatment and care procedures. Distraction techniques, 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. ShotBlocker and finger puppets are one of these techniques. 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 sampling in the pediatric blood sampling unit.

연구 개요

연구 유형

중재적

등록 (추정된)

90

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이

건강한 자원 봉사자를 받아들입니다

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 건강 서비스 연구
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Shotblocker Group
Shotblocker is administered to children during the blood sampling collection process.

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.
활성 비교기: Finger Puppet Group
Finger Puppet is administered to children during the blood sampling collection process.

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.
간섭 없음: Control Group
No intervention is performed on the control group during the blood sampling collection process.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Primary Outcome Measure
기간: Time frame is up to 12 moths. From October 01 2025 to October 01 2026.

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.

2차 결과 측정

결과 측정
측정값 설명
기간
Randomization
기간: Time frame is up to 15 minutes.

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.
Data Collection Tools
기간: Time frame is up to 15 minutes.
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.
Time frame is up to 15 minutes.
Children's Fear Scale (CFS)
기간: Time frame is up to 10 minutes.
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.
Time frame is up to 10 minutes.
Wong-Baker FACES (WB-FACES) Pain Rating Scale
기간: Time frame is up to 10 minutes.
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.
Time frame is up to 10 minutes.
ShotBlocker
기간: Time frame is up to 5 minutes.
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.
Time frame is up to 5 minutes.
Finger Puppet
기간: Time frame is up to 5 minutes.
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.
Time frame is up to 5 minutes.
Data Collection
기간: Time frame is up to 15 minutes.
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.
Time frame is up to 15 minutes.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 10월 1일

기본 완료 (추정된)

2026년 7월 10일

연구 완료 (추정된)

2026년 7월 10일

연구 등록 날짜

최초 제출

2026년 3월 11일

QC 기준을 충족하는 최초 제출

2026년 6월 12일

처음 게시됨 (실제)

2026년 6월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 12일

마지막으로 확인됨

2026년 3월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • AIBU-SBF-CC-01

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

The investigators will not share individual participant data for data privacy reasons.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

통증에 대한 임상 시험

Distraction techniques에 대한 임상 시험

구독하다