The Effect of Two Different Non-pharmacologic Methods (Buzzy® and DistrACTION® Cards) for Pain and Fear Relief During Blood Specimen Collection in Children: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Change in the Child's fear
研究概览
简要总结
Introduction: Pain is defined as an unpleasant emotional and sensorial feeling that arises from any part of the body progresses with possible tissue damage and covers all past experiences of individuals.
The aim of this randomized-controlled study is to compare the effect of two methods (Buzzy® and DistrACTION® Cards) used to reduce pain and anxiety during blood specimen collection in children.
Material and Methods: Children between the ages of 6 and 12 who come to the Tübingen University Rheumatology outpatient clinic will be included in the study.
Keywords: Pain, children, blood sample Research Hypotheses Hypothesis 0 (H0):There is no difference in terms of procedural pain and anxiety between children in the control group and interventions groups (Buzzy®, DistraCTION® Cards).
Hypothesis 1 (H1): Children who received Buzzy® during venous blood specimen collection have less pain and anxiety than children in the control group.
Hypothesis 2 (H2): Children who received DistrACTION® Cards during venous blood specimen collection have less pain and anxiety than children in the control group.
Hypothesis 3 (H3): Children who received Buzzy® during venous blood specimen collection have less pain and anxiety than children in the DistrACTION® Cards group.
In the study, we will use an information form that involves questions about the descriptive characteristics of the children and their families (parents' educational level, age, gender) and the blood specimen collection process (past and present experience), child's body mass index (BMI), the Children's Fear Scale (CFS) to determine the anxiety of the children and Faces Pain Scale-Revised (FPS-R) to evaluate pain. A pilot will be used to test whether the questions are understood before the questionnaires are administered.
Keywords: Pain, children, blood sample, buzzy, distractionCards
详细描述
The study will be carried out with the children and their parents who come to the rheumatology outpatient clinic at the University Hospital Tuebingen with their parents and met the sampling selection criteria.
An information letter describing the research study will be sent to the addresses of children and their families who meet the criteria before they come to the outpatient department.
When the child and parent come to the outpatient appointment:
- The study will begin after a doctor's examination, whose blood is decided to be drawn. Blood collection will be done in a separate room.
- The researcher will explain the study herself to the child (6-12 years old) and parents. First of all, the parents and children will be informed about the research via the "Information and Consent Form" (Appendix-2,3,4,5) and will be included in the study if they wish to participate. All participants will be informed about the possibility to withdraw their participation. Only participants who have received written and verbal consent to participate in the study will be included.
- According to the computer program (from 1 to 99), blood collection from the children will be done by the researcher herself, according to the order determined by the randomization.
Course of the study control and intervention group and examination methods:
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 (Participant)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children between the ages of 6-12 coming to the rheumatology outpatient clinic
排除标准
- •having a disease that causes chronic pain,
- •having a mental or neurologic disability,
- •have received analgesics within the last 6 hours,
- •history of fainting during blood collection,
- •with cold urticaria
研究组 & 干预措施
Buzzy
Buzzy®: It is a 8x5x2.5 cm sized, noninvasive device used for pain control in adults and children, developed by the pediatrician Ammy Baxter, with a plastic battery and vibration motor. A cold ice pack is placed under Buzzy. It has a local cold application and vibration effect. It is placed 3~5 cm above the injection site for 15~30 sec before and during the procedure, making local cold application and vibrations. One should be sure about the definite contact of Buzzy® with the skin. The ice pack is kept in a deep freezer and placed in the device before the procedure. After the procedure is completed, the ice pack is wiped with 70% alcohol, and kept and chilled again in the deep freezer. http://www.buzzy4shots.com/)
干预措施: Buzzy (Device)
DistractionCards
DistrACTION® Cards consisted of visual cards of 5 cm × 8 cm, covered with various pictures and shapes. In this method, the children first carefully examine the cards. Then, the PhD-qualified nurse researcher asks some questions about those cards to be answered by the children, such as "How many ladybugs are there in the picture?" "How many apes are there in the picture?" or "Can you see the comet?" The distraction procedure via distraction cards begin just before the venous blood specimen collection and continue until the end of the blood specimen collection
干预措施: DistrACTION® Cards (Other)
Control
Controll group: Venous blood will be taken as usual on the blood collection room without applying an intervention to the children in the Control group. Children will follow the standard blood draw procedure.
结局指标
主要结局
Change in the Child's fear
时间窗: Before and immediately after blood draw at 3-4 months
Befor and immediately after blood draw will be assessed with Children's Fear Scale (CFS) (parent) The Children's Fear Scale (CFS) was adapted from the Faces Anxiety Scale to measure fear in children undergoing painful medical procedures. Fear facial expressions are seen from 0 to 4. These faces are showing different amounts of being scared. This face \[the left-most face\] is not scared at all, this face is a little bit more scared \[second face from left\], a bit more scared \[sweep finger along scale\], right up to the most scared possible \[the last face on the right\].
次要结局
- Child's pain(immediately after blood draw at 3-4 months)