The Effect Of Getting Children Between 3-6 To Watch Small Aquarium Fish On Physiological Parameters, Pain and Stress During Blood Collection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Differences in crying time
研究概览
简要总结
Disease patterns are different from adults due to the fact that the abstract thinking and cause-effect abilities of children in the 3-6 age group are not developed. Children in this age group; Their ability to cope with stress is limited due to the need for special care, life experiences, mental development and inadequate ability to express themselves verbally (Conk et al, 2013). Illness is a source of pain and stress for them due to external factors and is a punishment for their bad behavior (Conk et al, 2013; Teksöz & Ocakçı, 2014).Hospital, on the other hand, means foreign environment/persons, loss of independence, loss of privacy, painful procedures, disruption of daily routines, surgery, pain, disability, death, separation from family and friends for children (Conk et al, 2013). Blood collection and vascular access are the interventions that cause the most pain, stress and anxiety in hospitalized children (Duff, 2003; Caprilli et al, 2007) . Non-invasive non-pharmacological methods increase the release of endorphins, the body's natural morphine, and relieve pain, thereby reducing the stress and anxiety of the child and family (Bergomi et al, 2018). Clinical experience argues that human-animal bonding, which is one of the distraction practices in pain management, is effective in reducing pain and stress (Muslu, 2011; Min & Zaw 2016; Alvarez et al, 2020) .
In the light of all this information; The aim of this study was to determine the effect of watching small aquarium fish, which is used as a distraction method during the blood collection process, on the pain and stress, heart rate and oxygen saturation during the procedure in children aged 3-6 years who applied to the blood collection unit.
Hypotheses of the Research:
Hypothesis 0 (H0): Feelings felt by children watching and not watching fish during blood collection there was no difference between stress, pain score, heart rate, oxygen saturation, crying and procedure time.
Hypothesis 1 (H1): The oxygen saturation of the children who watched the fish during the blood collection process is high.
Hypothesis 2 (H2): Children watching the fish during the blood draw have a higher heart rate is low.
Hypothesis 3 (H3): Children who watched the fish during the blood draw had a higher pain score is low.
Hypothesis 4 (H4): The stress score of the children who watched the fish during the blood collection process was higher is low.
Hypothesis 5 (H5): The crying time of the children watching the fish during the blood collection process is longer is short.
Hypothesis 6 (H6): The processing time is longer for children watching the fish during the blood collection process is short.
详细描述
The universe of the research will be all children brought to a training and research hospital for blood transfusion between March 2022 and March 2023. The sample of the study will be the children of parents who comply with the sample selection criteria and volunteer to participate in the research.
In order to determine the number of samples, power analysis was performed using the G*Power (v3.1.7) program. The power of the study is expressed as 1-β (β = probability of type II error), and in general studies should have 80% power. Based on the pain measurement differences before and after the procedure in Carie Braun's study to evaluate the pain during blood collection (difference of the means for the control group: 0.31; the difference of the mean for the experimental group was 1.61), the effect size was calculated to obtain 80% power at the α=0.05 level. (d) 0.748 was found. According to this, it was calculated that there should be at least 30 people in each group and 60 people in total. Considering that there may be losses during the study process, it was decided to take at least 35 people in each group.
Data Collection Tools and Materials: The following tools and forms will be used in the collection of research data: Informed Voluntary Consent Form (Appendix 1): Before starting the research, all children's parents should be informed about the purpose, plan, duration of the research, how the obtained data will be used "Voluntary Information and Consent Form" " and verbal and written permissions will be obtained. Parents who agree to participate in the study will be told that they can withdraw from the study at any time, they will be assured that the individual information obtained will not be disclosed to anyone other than the researcher, and that no fees will be charged to the parents or that no research expense will be charged to the social security institution to which the patient is affiliated.
Information Form (Appendix 2): It was prepared by scanning the literature on the subject. The information form is the form in which the child's name, surname, group, introductory information about the parents and the child are recorded. The information form will be filled by the researcher himself by face-to-face interview method. Follow-up Form (Appendix 3): It was prepared by scanning the literature on the subject. The follow-up form is the form in which the child's pain and stress score, physiological parameters, crying and duration of the procedure are recorded. The follow-up form will be filled in by the researcher himself in line with the findings obtained from the patient during data collection.
Pain Assessment Tool (FLACC) (Appendix 4):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
In this study, the Urn method, which is a randomization method equivalent to the full randomization method, will be used to determine the groups. In this randomization method, there are two parameters such as α and β. These parameters represent balls of two different colors, red and white. As a result of the lottery drawn in the research, the white ball will represent the "Animal assisted treatment group, and the red colored ball will represent the "Control Group". When there is a child who meets all the sampling criteria, the balls previously prepared by the researcher will be placed in a black bag and selection will be made by the nurse practitioner with their eyes closed. According to the color of the selected ball, it will be assigned to the child group, so that the children will be randomly distributed to the two groups.
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parents' willingness to participate in the research is in line with the voluntary consent form have obtained written consent from their parents,
- •The child is between 3-6 years old,
- •The child musn't not have fish,
- •No blood sampling has been performed in the last year,
- •If the child is considered healthy as a result of the examination performed by the doctor,
排除标准
- •if The child has fish
- •To have taken analgesic medication 4 hours before the procedure
- •if The child is afraid of fish,
- •The child has a known allergy history,
- •Deterioration of skin integrity in the blood collection area,
- •ifThe child has a visual/hearing disability.
- •if The child has developmental delay, mental problems
- •if there is Failure of blood collection in the first attempt.
研究组 & 干预措施
animal assisted therapy group
Animal assisted therapy group will watch aquarium fish while bloodletting prosedure.
干预措施: animal assisted therapy (Other)
Control Group
Control group will not watch aquarium fish while bloodletting prosedure.
结局指标
主要结局
Differences in crying time
时间窗: 1 year
Crying time will be measured by chronometer (second/minute)
Differences in stress
时间窗: 1 year
Children's Emotional Manifestation Scale-CEMS: Scale consists of a total of 5 different categories and 25 items. As the score obtained from the scale increases, the pain tolerance decreases, and as the score decreases, the tolerance increases.
Differences in procedure time
时间窗: 1 year
Prosedure time will be measured by chronometer (second/minute)
Differences in physiological parameters
时间窗: 1 year
Differences in oxygen saturation
Differences in pain score
时间窗: 1 year
Pain Assessment Tool (FLACC): The items take the value 0, 1, 2, respectively, and the total score is between 0 and 10. A "0" score indicates no pain, 1-3 points mild, 4-6 points moderate and 7-10 points severe pain.
次要结局
未报告次要终点
研究者
Tugba KARAKUS TURKER
Lecturer
Uskudar University