The Effect of Watching Video and Blowing Paper Pinwheels in Children
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Video-watching, Blowing Pinwheels.
- Кому может быть актуально
- Состояния в реестре: Pain, Fear. Базовые параметры: 3 лет — 6 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Тайвань
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Effect of Watching Video and Blowing Paper Pinwheels on Pain and Fear in Children Undergoing Venipuncture.
Обзор
The goal of this clinical trial is to evaluate if watching videos and blowing paper pinwheels can reduce pain and fear in children undergoing venipuncture. The participant population includes hospitalized children aged 3-6 years old undergoing venipuncture for the first time. The main questions it aims to answer are: 1. Does watching videos reduce pain and fear during venipuncture in children? 2. Does blowing paper pinwheels reduce pain and fear during venipuncture in children? Researchers will compare a group watching videos and a group blowing paper pinwheels to a control group receiving standard care to see if these interventions reduce pain and fear. Participants will: * Watch their preferred cartoons on an iPad during the venipuncture process. * Blow paper pinwheels to distract themselves during the venipuncture process. * Be accompanied by a family member who will help in holding the child and providing comfort.
Подробное описание
The goal of this clinical trial is to explore the effectiveness of watching videos and blowing paper pinwheels in reducing pain and fear in children undergoing venipuncture in children aged 3-6 years hospitalized for the first time and undergoing intravenous infusion or blood draw. The main questions it aims to answer are:
* Does watching videos reduce the pain experienced by children during venipuncture? * Does blowing paper pinwheels reduce the fear experienced by children during venipuncture?
If there is a comparison group: Researchers will compare the group of children watching videos and the group of children blowing paper pinwheels to the control group receiving standard care to see if these interventions are effective in reducing pain and fear during venipuncture.
Participants will:
* Be children aged 3-6 years hospitalized for the first time and undergoing intravenous infusion or blood draw. * Have no chronic diseases, developmental delays, or epilepsy. * Have no difficulty speaking, auditory or visual impairments, and have not used sedatives within 6 hours prior to the procedure.
Interventions:
Participants will be randomly assigned to one of three groups:
1. Video Watching Group:
* Children will choose their preferred cartoon videos. * They will watch the video on an iPad for 1 minute before and during venipuncture. * Parents will assist in stabilizing the child and providing comfort during the procedure. 2. Paper Pinwheel Blowing Group:
* Children will select a paper pinwheel of their choice. * They will practice blowing the pinwheel for 1 minute before the procedure. * During venipuncture, they will blow the pinwheel with parental assistance for stabilization and comfort. 3. Control Group:
* Children will receive standard care with parental presence but no additional interventions during venipuncture. * After the procedure, children will be allowed to play a "pinprick" game and choose a small toy as a reward.
Outcome Measures
The effectiveness of the interventions will be measured using the following tools
1. The Wong-Baker Faces Pain Scale (WBFPS):
* Used to assess children's self-reported pain levels before and after venipuncture. * Scores range from 0 to 10, with higher scores indicating greater pain. 2. Parental State Anxiety Scale:
* A Chinese version of the state anxiety scale will be used to measure parents' anxiety levels. * Scores range from 1 to 4 for each item, with higher scores indicating greater anxiety. 3. Parental Satisfaction Scale:
* A 0-10 scale will be used to measure parents' satisfaction with the venipuncture process. 4. The Children's Fear Scale:
* Used to assess children's fear levels before and after venipuncture. * Scores range from 0 to 4, with higher scores indicating greater fear. 5. FLACC (Face, Legs, Activity, Cry, Consolability) Pain Assessment Scale:
* Used to assess pain in non-verbal children based on facial expressions, leg movements, activity, cry, and consolability. * Scores range from 0 to 10, with higher scores indicating greater pain.
Study Design
This study will be conducted at the 66th Ward of Taichung Veterans General Hospital. After obtaining informed consent from parents and assent from children, participants will be randomly assigned to one of the three groups using a random number generator. The nurse performing the venipuncture will be blinded to the group assignment. Data will be collected by research personnel not involved in the data collection process.
Statistical Analysis
Descriptive statistics will include frequencies, means, and standard deviations. Inferential statistics will be conducted using ANOVA to determine the significance of the differences between groups.
Expected Outcomes
The study expects that children in the intervention groups (video watching and paper pinwheel blowing) will have lower pain and fear scores, and their parents will have lower anxiety scores and higher satisfaction compared to the control group. This research aims to improve the quality of care for hospitalized children undergoing venipuncture.
Handling of Adverse Reactions
If participants experience dizziness or discomfort during the intervention, the procedure will be stopped immediately, and necessary assistance will be provided.
Funding and Compensation
The study is funded by the Taichung Veterans General Hospital internal research project (project number: TCVGH-1137404B). Any adverse reactions caused by the study will be covered by the hospital, excluding anticipated side effects listed in the informed consent form.
Conflict of Interest There are no potential conflicts of interest associated with this study.
Вмешательства
- Поведенческое Video-watching
Participants will watch age-appropriate and engaging videos. - Поведенческое Blowing Pinwheels
Participants will blow pinwheels during the venipuncture procedure
Первичные конечные точки
- Wong-Baker Faces Pain Scale (WBFPS) for Children's Self-Reported Pain [Срок оценки: Assessed immediately before and after the venipuncture.]
- FLACC (Face, Legs, Activity, Cry, Consolability) Behavioral Pain Assessment Scale [Срок оценки: Assessed immediately before and after the venipuncture procedure.]
- Children's Fear Scale (CFS) [Срок оценки: Assessed immediately before and after the venipuncture procedure.]
Вторичные конечные точки (2)
- Parental State Anxiety Scale (PSAS) [Срок оценки: Assessed immediately after the child's venipuncture procedure.]
- Satisfaction of parents [Срок оценки: Assessed immediately after the child's venipuncture procedure.]
Критерии участия
Критерии включения
- aged 3-6 years.
- undergoing intravenous infusion or blood draw during the hospital stay.
Критерии исключения
- chronic diseases.
- developmental delays or epilepsy.
- difficulty speaking.
- hearing or visual impairments.
- use sedatives within the past 6 hours.
- history of fainting during intravenous infusion or blood draw.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Тройное слепое
- Основная цель
- Лечение
Центры проведения
Тайвань · 1 центр
- Taichung Veterans' General Hospital — Taichung
Публикации
- Shen T, Wang X, Xue Q, Chen D. Active versus passive distraction for reducing procedural pain and anxiety in children: a meta-analysis and systematic review. Ital J Pediatr. 2023 Aug 31;49(1):109. doi: 10.1186/s13052-023-01518-4. PMID 37653423
- Aydin D, Sahiner NC, Ciftci EK. Comparison of the effectiveness of three different methods in decreasing pain during venipuncture in children: ball squeezing, balloon inflating and distraction cards. J Clin Nurs. 2016 Aug;25(15-16):2328-35. doi: 10.1111/jocn.13321. Epub 2016 Apr 26. PMID 27112434
- Baxter AL, Cohen LL, McElvery HL, Lawson ML, von Baeyer CL. An integration of vibration and cold relieves venipuncture pain in a pediatric emergency department. Pediatr Emerg Care. 2011 Dec;27(12):1151-6. doi: 10.1097/PEC.0b013e318237ace4. PMID 22134226
- Hartling L, Newton AS, Liang Y, Jou H, Hewson K, Klassen TP, Curtis S. Music to reduce pain and distress in the pediatric emergency department: a randomized clinical trial. JAMA Pediatr. 2013 Sep;167(9):826-35. doi: 10.1001/jamapediatrics.2013.200. PMID 23857075
- Vetri Buratti C, Angelino F, Sansoni J, Fabriani L, Mauro L, Latina R. Distraction as a technique to control pain in pediatric patients during venipuncture. A narrative review of literature. Prof Inferm. 2015 Jan-Mar;68(1):52-62. doi: 10.7429/pi.2015.681052. PMID 25837616
- da Silva JR, Pizzoli LM, Amorim AR, Pinheiros FT, Romanini GC, da Silva JG, Joanete S, Alves SS. Using Therapeutic Toys to Facilitate Venipuncture Procedure in Preschool Children. Pediatr Nurs. 2016 Mar-Apr;42(2):61-8. PMID 27254974
- Rimon A, Shalom S, Wolyniez I, Gruber A, Schachter-Davidov A, Glatstein M. Medical Clowns and Cortisol levels in Children Undergoing Venipuncture in the Emergency Department: A Pilot Study. Isr Med Assoc J. 2016 Nov;18(11):680-683. PMID 28466619
- Piskorz J, Czub M. Effectiveness of a virtual reality intervention to minimize pediatric stress and pain intensity during venipuncture. J Spec Pediatr Nurs. 2018 Jan;23(1). doi: 10.1111/jspn.12201. Epub 2017 Nov 20. PMID 29155488
Идентификаторы
NCT: NCT06489353 · CF24157B