The Effect of Music Recital and Virtual Reality on Pain, Anxiety and Fear During Oral Mucositis Care in Children With Leukaemia: A Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- procedural pain
研究概览
简要总结
Children undergoing leukaemia treatment are exposed to a wide range of chemotherapeutic agents and immunosuppressive therapies during treatment and are therefore at great risk for complications. Mucositis is one of the leading chemotherapy-related complications affecting the quality of life of the child. Although it varies according to the degree of mucositis, oral mucosal erythema, white plaques and ulcers are extremely painful and traumatising procedures for pediatric patients during mucositis care. The pain and fear they experience during the procedure may lead children to delay/not perform oral mucositis care or not allow their parents to do so. Since mucositis is a painful condition in children, it is recommended to use distracting nonpharmacological methods that can help reduce the pain and fear of children during mucositis care. In this context, the aim of this study was to determine the effects of music and virtual reality on pain, anxiety and fear during oral mucositis care in children aged 6-12 years receiving leukaemia treatment. Block randomisation (gender (F/M) and age groups (6-9/10-12) will be used to identify participants. Five minutes before the oral mucositis care procedure, all participants, regardless of group, will be assessed with the Child Anxiety Scale-Disposition (CAS-D), Child Fear Scale and Visual Analogue Scale (VAS). The study will be conducted in three groups as control group, VR group and music group. Descriptive characteristics of dependent and independent categorical variables will be given as number and percentage, numerical descriptive characteristics will be given as mean and standard deviation. In examining the relationship between dependent and independent variables, Mann Whitney-Kruskal Wallis or Student t-Anova analyses will be performed according to the result of the analysis of conformity to normal distribution. Bonferroni analysis will be used for pairwise comparisons and Covariance analysis will be used to investigate the effect of variables with children.
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)
盲法说明
Oral mucositis care will be provided by the same clinic nurse in all groups in the study and this care provider will not be blinded to the intervention. The nurse will be accompanied by a researcher at this time. This person is the person who will collect the data for the scales and will not be blinded in the study. However, the person who will do the analyses of the study tests will be blinded to the groups.
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
- •The participant child
- •is between the ages of 6-12 years
- •is being followed up as an inpatient in the Paediatric Haematology Clinic
- •is receiving leukaemia treatment only
- •has oral mucositis
- •does not have a systemic infection
- •willing to participate in the study
- •speak Turkish and are open to communication
- •has no visual and hearing problems (not using glasses or hearing aids)
排除标准
- •Cases not fulfilling the inclusion criteria will be excluded from the study.
研究组 & 干预措施
Group1
Group2
Relaxing Music Session
干预措施: Music intervention (Procedure)
Group3
Short Film Session via VR (Relaxing Nature)
干预措施: Virtual reality (Procedure)
结局指标
主要结局
procedural pain
时间窗: Five minutes before starting the mucositis care procedure, the child's pain will be measured and baseline pain data will be collected. Pain data will be collected again immediately after the mucositis care procedure is completed.
The difference in pain score in different groups will be recorded.
anxiety
时间窗: Five minutes before starting the mucositis care procedure, the child's anxiety will be measured and baseline data will be collected. Anxiety data will be collected again immediately after the mucositis care procedure is completed.
The difference in anxiety score in different groups will be recorded.
fear
时间窗: Five minutes before starting the mucositis care procedure, the child's fear will be measured and baseline fear data will be collected. Fear data will be collected again immediately after the mucositis care procedure is completed.
The difference in fear score in different groups will be recorded.
次要结局
- duration of crying(After the procedure is explained to fam/child, the duration of crying will be recorded in all groups during the mucositis intervention. The recording will last till the last moment when the equipment used for care is removed from the mouth)
- duration of oral mucositis care(After the procedure is explained to fam/child, the duration of procedure will be recorded in all groups. The recording will last till the last moment when the equipment used for care is removed from the mouth)
研究者
SEDA ARDAHAN SEVGİLİ
Assistant Professor
Ege University