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临床试验/NCT07400874
NCT07400874尚未招募不适用

The Effects of Acupressure, Aromatherapy, and Virtual Reality on Pain, Fear, and Anxiety in Children During Blood Sampling Procedures

Artvin Coruh University0 个研究点目标入组 120 人开始时间: 2026年3月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
主要终点
1. Patient Identification Form

研究概览

简要总结

This study aims to evaluate the effects of acupressure, music listening, and virtual reality applications, which appeal to the senses of touch, hearing, and sight during blood sampling, on pain, fear, and anxiety levels in children.

详细描述

Two hundred volunteer children aged 5-10 coming for blood collection will be randomly divided into four groups: acupressure, virtual reality, Listening music and control group. Children will be assessed before, during, and after the procedure. Pain related to blood collection will be assessed with the Wong-Baker Faces Pain Scale, fear will be assessed with the Child Fear Scale and anxiety will be assessed with the Child Anxiety Scale - State. In addition, children's demographic data will be recorded in the Information Form.

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
Single (Outcomes Assessor)

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 5-10 years old Being healthy (no chronic disease diagnosis) Both child and parent agree to participate in the study Being able to communicate in Turkish Taking a blood sample in a single session Having no visual, auditory, or speech impairments, Being open to communication Being accompanied by a parent

排除标准

  • Having an allergy to any substance Having a chronic illness (Type 1 diabetes, etc.) Having upper respiratory tract diseases such as asthma, rhinitis, pharyngitis Having an obstructive condition in the nasal passages for any reason Having vision or hearing loss Having any neuropathological problem Having complaints of vomiting, nausea, or pain Having recently used sedatives, anesthetics, or analgesics Having a chronic illness Having visual-auditory and speech impairments History of sedative, analgesic, or narcotic substance use within 24 hours prior to admission

研究组 & 干预措施

Control Group

No Intervention

Routine clinical care will be applied to the control group. No action will be taken.

Experimental Group

Experimental

Before blood is drawn, the child will undergo acupressure, watch a video through virtual reality glasses, and listen to music through headphones.

干预措施: Virtual Reality (Other)

Experimental Group

Experimental

Before blood is drawn, the child will undergo acupressure, watch a video through virtual reality glasses, and listen to music through headphones.

干预措施: Acupressure (Other)

Experimental Group

Experimental

Before blood is drawn, the child will undergo acupressure, watch a video through virtual reality glasses, and listen to music through headphones.

干预措施: Listening Music (Other)

结局指标

主要结局

1. Patient Identification Form

时间窗: Baseline

The form consists of a total of 7 questions covering the child's age, gender, previous hospital experience (if any), number of hospitalizations, whether their parents prepared them for blood tests beforehand, their experience with blood tests in the last six months, and their reactions to the blood test procedure.

Wong Baker Face Pain Scale

时间窗: Baseline and up to 4 weeks

Children between the ages of three and eight can express many pain areas and their severity. In this study, the Wong-Baker Pain Inventory will be used in combination with the Visual Analog Scale, since face scales are more appropriate. The Wong Baker Face Pain Scale was developed by Donna Wong and Connie Moran Baker in 1981. The scale is suitable for children between the ages of three and eighteen. The scale includes facial expressions that the child can enjoy and enjoy. For this reason, it has been stated that it gives more accurate results. The scale has scores of "0", "2", "4", "6", "8", and "10". A score of "0" indicates no pain and a score of "10" indicates the highest pain. This scale does not have a Cronbach's alpha score. It has been reported that reliability studies have not been conducted on such scales.

3. Child Fear Scale

时间窗: Baseline and up to 4 weeks

The Turkish validity of this scale, developed by McMurtry and colleagues, was done by Gerçeker and colleagues. The changes in the facial muscles of the frightened expression were drawn by a graphic artist from a photograph of a frightened face. It can be used by the parent, child or researcher to scale the child's fear. The scale, which has facial expressions scored from 0 to 4, is shown to the child. A score of 4 indicates that the child is very frightened, and a score of 0 indicates that the child is not frightened. It is accepted that a score of "0" indicates a neutral expression (no fear), a score of "1" indicates a very low level of fear, a score of "2" indicates a little fear, a score of "3" indicates a greater level of fear, and a score of 4 indicates that the level of fear is at the highest level. This scale can be used to measure fear before and during the procedure.

4. The Child Anxiety Scale-State (CAS-S)

时间窗: Baseline and up to 4 weeks

Developed by Ersig et al. in 2013, the Child Anxiety Scale-State measures situational anxiety in children aged 4-10 years. Its validity was established by Gerçeker et al. in 2017. The CAS-S (State) is designed as a thermometer. At the bottom is a bulb, and horizontal lines extend upwards. Each horizontal line represents a score, and the thermometer has 10 points. The bulb at the bottom represents 0 points, indicating no anxiety. As the lines rise, anxiety increases. The peak, worth 10 points, represents the highest level of anxiety.

次要结局

未报告次要终点

研究者

发起方
Artvin Coruh University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gamze Akay

Assistant Professor

Artvin Coruh University

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