Effects of Therapeutic Touch and Music on Anxiety, Pain, and Nausea in Children Before and After Circumcision: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 105
- 主要终点
- Pain Intensity
研究概览
简要总结
This randomized controlled trial aims to evaluate the effects of therapeutic touch and music therapy on anxiety, pain, and nausea in children undergoing circumcision surgery. Circumcision is a common surgical procedure, and children often experience significant anxiety, pain, and nausea both before and after the operation. The study involves children aged 7 to 12 years old who are scheduled for circumcision at Iğdır State Hospital. Participants will be randomly assigned to one of three groups: a therapeutic touch group, a music therapy group, or a control group. The goal of this research is to determine if applying non-pharmacological methods-specifically therapeutic touch or listening to music-for 15 minutes before and after the surgery can effectively reduce children's anxiety, pain levels, and nausea compared to standard care.
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
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged between 7 and 12 years
- •Children and parents who provide written and verbal informed consent
- •Children without any chronic diseases
- •Children and parents without visual impairments
排除标准
- •Children and parents who refuse to participate or do not volunteer for the study (do not sign the consent form)
- •Participants who display behaviors incompatible with the research content -Participants who subsequently refuse to participate in the research after initial consent
- •Participants with incomplete data
结局指标
主要结局
Pain Intensity
时间窗: Four specific time points: (1) Baseline before any intervention is applied, (2) 15 minutes after the pre-operative intervention, (3) 60 minutes post-operation after sedation has worn off and the child is conscious, and (4) 15 minutes after the post-op.
Pain intensity will be evaluated using the Wong-Baker FACES Pain Rating Scale. This assessment tool uses a scoring system ranging from 0 to 5, where 0 represents "no pain" and 5 represents "very severe pain," correlating with the patient's chosen facial expression.
Nausea Severity
时间窗: Four specific time points: (1) Baseline before any intervention is applied, (2) 15 minutes after the pre-operative intervention, (3) 60 minutes post-operation after sedation has worn off and the child is conscious, and (4) 15 minutes after the post-op
Nausea will be assessed using the Baxter Retching Faces (BARF) Nausea Scale. This pictorial scale consists of six faces and is scored from 0 to 10, where 0 indicates no nausea/vomiting and 10 indicates severe nausea/vomiting.
Anxiety Level
时间窗: Four specific time points: (1) Baseline before any intervention is applied, (2) 15 minutes after the pre-operative intervention, (3) 60 minutes post-operation after sedation has worn off and the child is conscious, and (4) 15 minutes after the post-op.
The children's state anxiety will be measured using the Children's Anxiety Scale-State (CAS-S) / Çocuk Anksiyete Skalası-Durumluluk (ÇAS-D). This is a visual analog scale shaped like a thermometer with a bulb at the bottom and horizontal lines increasing upwards, specifically designed for children aged 4 to 12. Children are instructed to indicate their level of worry or tension by drawing a line on the thermometer. Before administering the scale, the child's ability to understand instructions and sequence numbers (such as counting to 10 or determining if 7 or 4 is larger) is evaluated; children who cannot complete these cognitive tasks do not complete the scale. The total score ranges from 0 to 10, with higher scores representing higher levels of anxiety.
次要结局
未报告次要终点
研究者
özlem ABI
lecturer
Igdir University