Cognitive-Behavioral Intervention Package for Port Catheter Needle Insertion: Effects on Pain, Anxiety, and Fear in Children With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Sociodemographic Characteristics Form (SCF)
研究概览
简要总结
This study aims to determine the effect of the Cognitive-Behavioral Intervention Package (CBIP) applied during port catheter needle insertion on pain, anxiety, and fear levels in children aged 6-18 years diagnosed with oncology.
Research Hypotheses
Between the Cognitive-Behavioral Intervention Package group (G1) and the control group (G2):
H1: There is a difference in the mean scores of the Wong-Baker FACES Pain Rating Scale (WB-FPRS) between the groups.
H2: There is a difference in the mean scores of the Children's Anxiety Scale between the groups.
H3: There is a difference in the mean scores of the Children's Fear Scale between the groups.
Prior to the intervention, researchers will administer the scales to the intervention group, followed by the implementation of the CBIP. After the port catheter needle insertion, the scales will be re-administered to evaluate the final levels of pain, anxiety, and fear.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are 6-18 years old,
- •Have a cancer diagnosis,
- •Have undergone at least one prior port catheter needle insertion,
- •Are willing to participate along with parental consent.
排除标准
- •Have any visual, auditory, verbal, or cognitive impairment,
- •Are in the terminal stage of the disease,
- •Have a history of sedative, analgesic, or narcotic use within 24 hours prior to enrollment,
- •Have a fever or history of infection at the time of enrollment,
- •Have a pre-procedure WB-FPRS score of 2 or higher unrelated to the procedure,
- •Do not complete the study.
研究组 & 干预措施
Cognitive-Behavioral Intervention Package Group
Before the procedure, children's pain, anxiety, and fear were assessed by the child, parent, and researcher. In the CBIP group, preparation, briefing, and implementation stages were conducted. The researcher met with the child and parent for preparation and briefing. A volunteer parent was trained to support the child during the procedure (e.g., sitting next to the child, holding hands, talking). Port catheter needle insertion was performed according to unit routine by the same nurse with 5 years' experience, using a single attempt. After the procedure, children rated pain (WB-FPRS), fear (CFS), and anxiety (CAS); the observing parent and researcher also completed CFS and CAS.
干预措施: CBIP - Cognitive-Behavioral Intervention Package (Behavioral)
Control Group
In the study, children in the control group will receive the routine clinical procedure prior to the intervention, followed by port catheter needle insertion.
结局指标
主要结局
Sociodemographic Characteristics Form (SCF)
时间窗: At baseline, prior to intervention (Day 1)
The form was developed by the researchers based on the literature. It consists of 11 questions addressing the sociodemographic characteristics of parents and children, as well as the status of port catheter needle insertion.
Wong-Baker FACES Pain Rating Scale (WB-FPRS)
时间窗: Before and after port catheter needle insertion (Day 1).
Pain will be assessed using the Wong-Baker FACES Pain Rating Scale (WB-FPRS) and completed by the child before and after the port catheter needle insertion. Scores range from 0 to 5, where 0 indicates no pain and 5 indicates unbearable pain.
Children's Fear Scale (CFS)
时间窗: Before and after port catheter needle insertion (Day 1).
Fear will be assessed using the Children's Fear Scale (CFS) by the child, parent, and researcher before and after the port catheter needle insertion. Scores range from 0 to 4, where 0 indicates no fear and 4 indicates extreme fear.
Children's Anxiety Scale-State (CAS-S)
时间窗: Before and after port catheter needle insertion (Day 1).
Anxiety will be assessed using the Children's Anxiety Scale-State (CAS-S) as reported by the child, parent, and researcher before and after the port catheter needle insertion. Scores range from 0 to 5, where 0 indicates no anxiety and 5 indicates extreme anxiety.
次要结局
未报告次要终点
研究者
Birgul Erdogan
Principal Investigator, Research Assistant, PhD
Kocaeli University