Comparison of the Effects of Ball Squeezing and Adhesive Remover Use on Pain and Fear in Children Aged 6-9 Years During the Removal of Peripheral Intravenous Cannula: A Randomised Experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Pain assesed by Wong-Baker FACES
研究概览
简要总结
Pediatric nurses have a key role in reducing pain related to interventions during the hospitalisation process. In this context, according to the type of invasive intervention, the nurse determines the appropriate non-pharmacological methods for the effective management of pain, taking into account the child's individuality, developmental stage and clinical presentation. For children during the hospitalisation process, the removal of a peripheral venous line is a painful and stressful experience, as is the insertion of a peripheral venous line. Children experience acute pain during the removal of hypoallergenic adhesives used for fixation of the peripheral venous line. The practice guideline recommends the use of alcohol-free silicone-based aerosol sprays for the removal of medical adhesive/ fixation materials (NICU Brain Sensitive Care Committee, 2015).
In this study, it was aimed to examine the effect of ball squeezing (active distraction) as a distraction method and the use of alcohol-free silicone-based aerosol adhesive remover spray on pain and fear in children aged 6-9 years during peripheral intravenous cannula removal.
详细描述
Research Hypotheses:
H1= There is a difference in the mean WB-FACES score during the procedure between the groups.
H2= There is a difference in the mean CFS score during the procedure between the groups.
Design and Settings: This parallel-group randomized trial will be conducted at the invasive procedure room of the pediatrics department of a university hospital. For this experimental research, 90 children aged 6-9 years will be assigned to three groups (Standard Care Group= SCG; n = 30, Adhesive Remover Spray Group = ARSG; n=30, and Ball Squeezing + Adhesive Remover Spray Group=BSG; n = 30) using block randomization.
Sample Size: The trial sample was calculated based on the study findings of "Ugucu, G., Uysal, D. A., Polat, O. G., Artuvan, Z., Kulcu, D. P., Aksu, D., ... & Temel, G. O. (2022). Effects of cartoon watching and bubble-blowing during venipuncture on pain, fear, and anxiety in children aged 6-8 years: a randomized experimental study. Journal of Pediatric Nursing, 65, e107-e114.". A priori power analysis was performed based on the effect size (d = 0.885, large effect) of the difference in pain scores between the groups (during the procedure). Using G*Power 3.1.9.7, the minimum sample size was calculated as 74 children, with 28 children per group, for a two-tailed hypothesis, an effect size of d = 0.885, an allocation ratio of n1/n2=1, type I error of 0.05, and a power of 90%. Considering that there may be drop-outs during the process, the number of groups was increased by 10%. The sample size of this study was determined as 90 children (30 children in each intervention group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The children and their parents will be blinded to the groups. The principal researchers (R1, R2) will be blinded to the research hypotheses. The opaque envelopes are stored in a locked cabinet by the researcher who performed the randomization. Data entries will be performed using the codes A, B and C. Codes will be shared with the researchers after statistical analyses are conducted and the research report is written.
入排标准
- 年龄范围
- 6 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child aged 6-9 years
- •Child with need or plan for the removal of the peripheral intravenous cannula (antecubital fossa of arm, superficial dorsal venous of hand)
排除标准
- •Child with a neurodegenerative disease, mental retardation, vision and hearing problems, chronic, life-threatening (sepsis, shock, respiratory / cardiac arrest) or genetic disease
- •Child with use of opioids, narcotics, analgesics or sedatives in the last 24 hours before the procedure
研究组 & 干预措施
Standard Care
First, the physical comfort of the children will be ensured in the invasive procedure room. In standard care practice, the parental presence is supported during all invasive procedures performed on children. Two minutes before the removal of the peripheral intravenous cannula, cotton balls soaked in antiseptic solution and squeezed will be gently applied to the fixation area.
干预措施: Standard Care (Other)
Adhesive Remover Spray
First, the physical comfort of the children will be ensured in the invasive procedure room. Two minutes prior to the removal of the peripheral intravenous cannula, an alcohol-free silicone-based aresol spray for medical use will be gently applied to the fixation site. The children will be supported by their parents.
干预措施: Adhesive Remover Spray (Other)
Ball Squeezing + Adhesive Remover Spray
: First, the physical comfort of the children will be ensured in the invasive procedure room. Two minutes prior to the removal of the peripheral intravenous cannula, an alcohol-free silicone-based aresol spray for medical use will be gently applied to the fixation site. At the same time, children will start squeezing the stress ball. The ball squeezing intervention will be terminated when the removal of the peripheral intravenous cannula is completed. The children will be supported by their parents.
干预措施: Ball Squeezing + Adhesive Remover Spray (Behavioral)
结局指标
主要结局
Pain assesed by Wong-Baker FACES
时间窗: during the removal of the peripheral intravenous cannula
The Wong-Baker FACES (WB-FACES) Pain Rating Scale used. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10. Faces show emotions from smiling (0 = very happy/ no pain) to crying (10 = hurts worst).
Fear by Children's Fear Scale
时间窗: during the removal of the peripheral intravenous cannula
The Child Fear Scale was used.This one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to 4 (extreme fear). Higher scores mean a worse outcome.
次要结局
- Pain assesed by Wong-Baker FACES(at 2nd minutes after the removal of the peripheral intravenous cannula)
- Fear by Children's Fear Scale(at 2nd minutes after the removal of the peripheral intravenous cannula)
研究者
Guzide UGUCU
Principal Investigator
Mersin University