Comparison of the Effects of Music and White Noise on Fear, Anxiety and Pain Levels in Children Performed Endoscopy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Child fear scale
研究概览
简要总结
The study was planned as a randomized controlled experimental study to compare the effects of music and white noise on fear, anxiety and pain levels before, during and after the procedure in school-age children (6-12 years old) who will undergo endoscopy.
Hypothesis 0 (H0): There is no difference in fear, anxiety, pain, parental anxiety and pulse, respiration and oxygen saturation values between children exposed to music and white noise.
Hypothesis 1 (H1): Children who were exposed to music and white noise had lower fear scores than children who were not exposed to any application.
Hypothesis 2 (H2): Children who were exposed to music and white noise had lower anxiety scores than children who were not exposed to any application.
Hypothesis 3 (H3): Children who were exposed to music and white noise had lower pain scores than children who were not exposed to any application.
Hypothesis 4 (H4): Children who were exposed to music and white noise had lower pulse value scores than children who were not exposed to any application.
Hypothesis 5 (H5): Children who were exposed to music and white noise had lower respiratory rate scores than children who were not exposed to any application.
Hypothesis 6 (H6): Children who were exposed to music and white noise had higher oxygen saturation value scores than children who were not exposed to any application.
Hypothesis 7 (H7): Parents of children who were exposed to music and white noise had lower parental anxiety than parents of children who were not exposed to any treatment.
There are music group, white noise and control group in the study.
详细描述
The independent variables of the study are age, gender, music and white noise application.
The dependent variables are; Children's Fear Scale (CFS) scores used to measure children's fear, Children's Anxiety Scale-State (CAS-D) scores used to measure anxiety, The Faces Pain Scale Revised (FPS-R) scores used to measure pain status, pulse, respiratory rate and oxygen saturation values and Beck Anxiety Inventory scores obtained from parents.
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
- 否
入选标准
- •School age (6-12 years old) child,
- •Have not had an endoscopy procedure before,
- •Have not had a surgical procedure before,
- •Have been requested to have an endoscopy by a physician,
- •Be able to communicate,
- •Have no hearing or speech problems,
- •Agree to participate in the study,
- •Have not used analgesics for 6 hours before the procedure,
- •The child can count from 1 to 10,
- •Have the ability to order numbers (knowing that numbers are big or small (e.g. 6 is less than 7, 4 is greater than 2, etc.).
排除标准
- •Not being of school age (under 6 years old, over 12 years old),
- •Having had an endoscopy procedure before,
- •Having had a surgical procedure before,
- •Not being able to communicate,
- •Having hearing and speech problems,
- •Not agreeing to participate in the study,
- •Having used analgesics up to 6 hours before the procedure,
- •The child not having the ability to sort and count numbers.
结局指标
主要结局
Child fear scale
时间窗: six months
The Child Fear Scale (CFS), developed by McMurty and colleagues (2011), consists of five drawn facial expressions ranging from a neutral expression (0 = no anxiety) to a frightened face (4 = severe anxiety). The validity and reliability of the scale were performed by Gerçeker and colleagues (2018). The CGI value for the CFS is 0.89 (McMurty et al., 2011).
Child anxiety scale-state
时间窗: six months
The Child Anxiety Scale State (CAS-S) developed by Ersig et al. (2013) is used to measure the anxiety of the child's current situation. The validity and reliability of the scale were made by Gerceker et al. (2018). The Content Validity Index (CVI) value for CAS-S was found to be 1.00.
The Faces Pain Scale - Revised
时间窗: six months
It is a self-report measure of pain intensity developed for children. It has been made more suitable for use by using visual depictions of six facial expressions representing increasing levels of pain intensity and by adapting the metric scoring to 0-10. The revised version of the facial pain scale is widely used in the adult and pediatric populations for pain intensity assessment. It is easy to apply and does not require any equipment other than the faces in the picture.
次要结局
- Beck Anxiety Inventory(six months)
- pulse value(six months)
- respiratory value(six months)
- oxygen saturation value(six months)
研究者
Busra Inac Yilmaz
IstanbulUC
Istanbul University - Cerrahpasa (IUC)