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临床试验/NCT07312084
NCT07312084已完成不适用

The Effect of Two Different Types of Hourglasses on Pain, Fear, and Anxiety During Blood Collection in Children: A Randomized Controlled Trial

Hakkari Universitesi1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Pain During Venous Blood Collection in Children (Wong-Baker Facial Pain Scale)

研究概览

简要总结

This research will be conducted as a pre-test-post-test parallel group randomized controlled experimental study to determine the effects of two different types of hourglasses (liquid gel-based hourglass and sand-based hourglass) used for distraction during blood collection in children aged 5-10 years on pain, fear, and anxiety and the comparative effectiveness of these methods.

Research Hypotheses H1: The mean pain, fear, and anxiety scores of children who used a liquid gel-based hourglass during blood collection were significantly lower than the mean scores of children in the control group.

H2: The mean pain, fear, and anxiety scores of children who used a sand-based hourglass during blood collection were significantly lower than the mean scores of children in the control group.

H3: The use of a liquid gel-based hourglass and a sand-based hourglass during blood collection had different effects on the mean pain, fear, and anxiety scores of children.

详细描述

Pain, fear, and anxiety experienced by children during medical procedures constitute a significant clinical and psychosocial concern. Venipuncture, particularly common among invasive procedures performed on children aged 5-10 years, can trigger strong emotional reactions in this age group. These reactions may negatively affect not only the procedure itself but also children's long-term trust in the healthcare system, treatment adherence, and tolerance of future procedures.

Failure to effectively manage the anxiety and fear that arise during invasive procedures in children may lead to movement, increased pain, delays in the procedure, and challenges in terms of staff safety. Moreover, children who experience high levels of fear and anxiety may later avoid similar procedures, which poses a serious risk for access to healthcare services and adherence to treatment. Therefore, identifying and optimizing non-pharmacological, low-cost, and feasible methods used during invasive procedures is of utmost importance.

One of the non-pharmacological strategies used to reduce pain, fear, and anxiety during invasive procedures in children is active and passive distraction. Active distraction methods involve the child's engagement in surrounding activities such as playing games, crafts and coloring, tablet/computer games, role-play, and storytelling. These methods require the child to use hand-eye coordination, cognitive skills, or imagination and often reduce pain and anxiety more effectively. Passive distraction methods rely on the child's observation or listening to an activity and include watching videos/cartoons, listening to music or stories, and observing visual toys (e.g., sand timers). These methods provide visual and auditory stimuli that help redirect attention away from painful cues and are generally easy to implement. In summary, while active methods involve the child's active participation in the process, passive methods rely solely on focusing on an external stimulus. Studies in the literature indicate that both methods play an important role in reducing pain, fear, and anxiety experienced by children during invasive procedures.

Among passive distraction methods, sand timers are used as visual toys. The reason for selecting two different types of sand timers for children is the potential for their visual and cognitive stimulus properties to influence levels of pain, fear, and anxiety differently. The traditional sand-based timer offers a simple visual stimulus by displaying the natural flow of sand and is familiar and calming for most children. In contrast, liquid gel-based timers provide a more dynamic and attention-grabbing stimulus through colorful liquid and varying flow speeds. These differing characteristics may influence how effectively children's attention can be diverted from painful cues during venipuncture. However, the literature on the effectiveness of visual distractors such as sand timers remains limited. Sand timers are simple, portable, and low-cost tools to capture children's attention, but differences between sand-based (traditional) and liquid gel-based versions-such as visual effects, flow speed, and color variations-have not been fully explored regarding their impact on pain, fear, and anxiety. This gap creates uncertainty about which type is more effective in clinical practice.

Systematically evaluating the effects of liquid gel-based and traditional sand timers on children's experience during invasive procedures may provide valuable evidence for nursing practice and pediatric care protocols. If simple and low-cost tools such as sand timers can reduce pain, fear, and anxiety during venipuncture, their widespread use may enhance children's procedural experiences and improve their cooperation and morale. Lower levels of pain and fear may help children move less during the procedure, increasing the safety of both the child and healthcare staff and supporting their compliance with future procedures. Furthermore, compared with medication- or device-based interventions, sand timers offer economic and logistical advantages; their ease of application in clinical settings and minimal training requirements make them highly feasible for practice.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

In order to prevent bias, support will be obtained from an independent statistician. In addition, data will be collected by a nurse who does not know the groups not included in the study.

入排标准

年龄范围
5 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Being between 5 and 10 years old,
  • Agreeing to participate in the research by applying to the blood collection unit,
  • Written consent being obtained from the parent,
  • Physical and mental development being appropriate for the age.

排除标准

  • Being outside the specified age range,
  • Having a serious chronic disease or hematological disorder,
  • Having developed serious trauma or intense anxiety due to a previous blood draw,
  • Refusal to participate in the study or failure to obtain parental consent,
  • Psychiatric or neurological disorders that may affect the implementation of the study.

研究组 & 干预措施

Liquid Gel-Based Hourglass

Experimental

The liquid gel-based hourglass used in the study is approximately 13-14 cm long and made of high-quality plastic. It contains a highly viscous colored gel, which flows slowly and regularly in a drop-like pattern. These hourglasses are used during interventions not to measure time but to increase visual focus, distract attention, and provide a calming effect.

干预措施: Liquid Gel-Based Hourglass (Other)

Sand-Based Hourglass

Experimental

The sand-based hourglass used in the study is approximately 8.5 cm long and made of durable plastic and glass. It contains colored, fine-grained, dry sand. It's a classic mechanism that relies on the fine-grained sand flowing from the upper chamber to the lower chamber under the influence of gravity. This type of hourglass is used as a helpful tool to distract children and reduce procedural anxiety during the intervention.

干预措施: Sand-Based Hourglass (Other)

Control Group

No Intervention

Children in this group will not receive any pharmacological or non-pharmacological intervention other than routine blood collection.

结局指标

主要结局

Pain During Venous Blood Collection in Children (Wong-Baker Facial Pain Scale)

时间窗: "1 year"

"Pain is a specific unpleasant sensation originating from any part of the body, encompassing all past experiences of a person, whether or not due to an organic cause." The aim of the scale is to determine the level of pain based on numerical values corresponding to target facial expressions. Numerical values between 0 and 10 are used. A value of 0 indicates no pain, while a value of 10 indicates severe pain.

Fear During Venous Blood Collection in Children (Child Fear Scale)

时间窗: "1 year"

"It is a vital response that occurs as a response to a stimulus that is perceived as a specific pain or threat." The scale was developed to determine the level of fear in children aged 4-10 years. The scale uses facial expressions and is scored on a scale of "0-4". A score of "0" indicates no fear, while a score of "4" indicates excessive fear.

Anxiety During Venous Blood Collection in Children (Child Anxiety Scale - State)

时间窗: "1 year"

"It is a common psychological disorder that causes a person to have excessive and uncontrollable reactions to emotions such as worry, anxiety and fear." The CAS-D scale is shaped like a thermometer with a lightbulb at the bottom and horizontal lines at intervals going upwards. To measure CAS-D, the child is asked to indicate what they are feeling "right now." The scale is scored from 0 to 10. Children are asked to indicate their feelings of anxiety and nervousness from the bottom of the thermometer upwards (from least to most). Before using the scale, the child's sequencing skills are assessed. After being asked to count to ten, they are asked questions about which of two numbers is larger or smaller. Children who cannot follow the instructions or answer these questions are excluded from the scale.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dilek Demir Kösem

Associate Professor

Hakkari Universitesi

研究点 (1)

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