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临床试验/NCT05619991
NCT05619991已完成不适用

Effect of Short Film Video and Video-Based Education on Fear, Pain, and Satisfaction of Children Undergoing Day Surgery

Tarsus University5 个研究点 分布在 2 个国家目标入组 90 人开始时间: 2022年12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
发起方
入组人数
90
试验地点
5
主要终点
Introductory Information Form

研究概览

简要总结

It is aimed to investigate the effect of introducing the operating room environment with an informative video to pediatric patients aged 7-12 in the preoperative period in day surgery on pain, fear, and patient and parent satisfaction. In line with this purpose, an answer was sought to the question "How did the different education programs given to children who will undergo day surgery have an effect on fear, pain and satisfaction?" It will be conducted in a single center, parallel group, randomized controlled experimental design. The research will be carried out between December 2022 and October 2023 and it is planned to continue for 12 months. The population of the research will be children between the ages of 7-12 who will undergo a day surgery at Tarsus State Hospital, and the sample will be 90 children who meet the criteria for inclusion in the research. Considering that there may be case losses, a total of 90 children (1st experimental group [watched video training]:30 children, 2nd experimental group [provided planned training]: 30 children, control group: 30 children) will be included in the sample group. In the collection of research data; Introductory Information Form, Numerical Pain Scale, Child Fear Scale, Vital Signs Follow-up Form (Appendix 4) will be used. The application will be started after the approval of the ethics committee and the written permission of the institution for the research. Statistical package program (SPSS 20) will be used in the analysis of the research data.

详细描述

In this study, it is aimed to investigate the effect of introducing the operating room environment with an informative video to pediatric patients aged 7-12 in the preoperative period in day surgery on pain, fear, and patient and parent satisfaction. It will be conducted in a single center, parallel group, randomized controlled experimental design. Randomization will be provided by randomly and evenly distributing the patients who meet the sample selection criteria into 3 groups (1st experimental group, 2nd experimental group and 3rd group control group) through a program in the computer environment. (http://www1.assumption.edu/users/avadum/applets/RandAssign/GroupGen.html). The application will be started after the approval of the ethics committee and the written permission of the institution for the research.

Stage 1: The information content to be included in the video will be determined by the researchers, taking the opinions of the experts on the subject, appropriate for the level of the child in the 7-12 age group, for daily surgical intervention (about preparation for surgery, the operating room environment and the post-operative process), and video content will be created. .

Stage 2: In line with the suggestions from researchers and experts, an informative video will be prepared for day surgery (preparation for surgery, operating room environment and the post-operative process) appropriate for the level of the child in the 7-12 age group.

Stage 3: A pilot study will be conducted with 10 children in order to evaluate the data collection forms to be used before the research and the suitability of video education for children.

Stage 4: The children in the sample group and their parents will be informed about the method followed in practice and the research, and verbal and written consent will be obtained.

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
None

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • To be 7 and 12 years old
  • Having day surgery
  • Not having undergone previous surgery
  • Not have a chronic disease
  • No communication, mental or neurological problems
  • Volunteering to participate in the study

排除标准

  • Not be in the 7-12 age range
  • Not to have day surgery
  • Having had previous surgery
  • have a chronic illness
  • Having another chronic illness
  • Have a communication, mental, or neurological problem
  • Not willing to participate in the study

研究组 & 干预措施

Group watching video

Experimental

For the Educational Video, a scenario appropriate for the age group, about the preparation for the surgery, the operating room environment and the post-operative process will be created by the researchers. Expert opinion will be taken for the suitability of the scenario.

干预措施: Group watching video (Other)

Scheduled training group

Other

For the Planned Education, a power point presentation will be prepared by the researchers, appropriate for the age group, about the preparation for the surgery, the operating room environment and the post-operative process, and the patients will be trained before the surgery.

干预措施: Scheduled training group (Other)

Control group

No Intervention

Before the operation, the fear and vital signs of the children in the sample will be evaluated. In the postoperative period, the pain, fear and vital signs of the children in the control group will be recorded and a questionnaire examining the satisfaction status will be applied.

结局指标

主要结局

Introductory Information Form

时间窗: 1 day

Introductory Information Form, which was created by the researcher in line with the knowledge of the literature, consists of questions about the child's age, gender, educational status, and characteristics of the procedure (Baghele et al., 2019; Eijlers et al., 2019; Yaz \& Yılmaz, 2021).

The Vital Signs Follow-up Form

时间窗: 1 day

The Vital Signs Follow-up Form was prepared to record the vital signs of children measured before and immediately after the procedure, such as heart rate, blood pressure, saturation value and respiration.

Child Fear Scale

时间窗: 1 day

Child Fear Scale, McKinley et al. (2003) as "The Faces Anxiety Scale" for adult patients. The same scale was adapted for pediatric patients as "Children's Fear Scale" by McMurtry et al. (2011). This Scale includes 5 different facial expressions. This scale is scored between 0 and 4, and it is stated to be a reliable and valid measurement tool in the evaluation of fear.

Numerical Pain Scale

时间窗: 1 day

Numerical Pain Scale, this method for determining the severity of pain, aims to explain the patient's pain in numbers. Absence of pain (0) is evaluated as unbearable pain (10) on numerical scales.

The Child Satisfaction Scale

时间窗: 1 day

The Child Satisfaction Scale was developed by researchers in a way that children can easily understand (Çelik, 2020). The numbers between 0 and 10, which the children would indicate by circling the point corresponding to their satisfaction with the education provided, were placed on a horizontal line. On the scale, 0 points means "not at all satisfied" and 10 points means "extremely satisfied". In addition, images reflecting the degree of satisfaction have been added to the places where the scores are located. In the study, it is planned to be applied to all groups after surgery.

Introductory Information Form

时间窗: 11 MONTHS

Introductory Information Form, which was created by the researcher in line with the knowledge of the literature, consists of questions about the child's age, gender, educational status, and characteristics of the procedure (Baghele et al., 2019; Eijlers et al., 2019; Yaz \& Yılmaz, 2021).

Child Fear Scale

时间窗: 11 MONTHS

Child Fear Scale, McKinley et al. (2003) as "The Faces Anxiety Scale" for adult patients. The same scale was adapted for pediatric patients as "Children's Fear Scale" by McMurtry et al. (2011). This Scale includes 5 different facial expressions. This scale is scored between 0 and 4, and it is stated to be a reliable and valid measurement tool in the evaluation of fear.

Numerical Pain Scale

时间窗: 11 MONTHS

Numerical Pain Scale, this method for determining the severity of pain, aims to explain the patient's pain in numbers. Absence of pain (0) is evaluated as unbearable pain (10) on numerical scales.

The Vital Signs Follow-up Form

时间窗: 11 MONTHS

The Vital Signs Follow-up Form was prepared to record the vital signs of children measured before and immediately after the procedure, such as heart rate, blood pressure, saturation value and respiration.

The Child Satisfaction Scale

时间窗: 11 MONTHS

The Child Satisfaction Scale was developed by researchers in a way that children can easily understand (Çelik, 2020). The numbers between 0 and 10, which the children would indicate by circling the point corresponding to their satisfaction with the education provided, were placed on a horizontal line. On the scale, 0 points means "not at all satisfied" and 10 points means "extremely satisfied". In addition, images reflecting the degree of satisfaction have been added to the places where the scores are located. In the study, it is planned to be applied to all groups after surgery.

次要结局

未报告次要终点

研究者

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

Gamze BOZKUL

Research asistant

Tarsus University

研究点 (5)

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