A Randomised Control Trial of Strategies to Maximise Patient Comfort During Extracorporeal Shockwave Lithotripsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Pain score
研究概览
简要总结
Extracorporeal shockwave lithotripsy is an outpatient treatment for patients with intrarenal calculi. Standard of care involves offering oral analgesia prior to commencing the treatment. Most patients do not take the offered analgesia after the initial treatment. It has been suggested that distraction techniques may be equivalent to oral analgesia in improving tolerability of extracorporeal shockwave lithotripsy treatment. The use of distraction techniques also removes the potential side effects of mediation administration.
详细描述
The investigators are aiming to assess if distraction techniques help improve patient comfort while undergoing extracorporeal shockwave lithotripsy treatment for renal calculi. Improved tolerability of treatment would result in longer duration of time on the lithotripsy machine and may lead to better stone fragmentation. Outcomes will be completion of treatment and scores on the short form McGill pain questionnaire.
Patients will be randomised into three groups. The randomisation will not be blinded as this is not possible within the design of the study. The first group will be given stress balls to squeeze during treatment and will also receive standard care (the offer of oral analgesia). The second group will be given headphones to listen to music during treatment and will also receive standard care. The third group will receive standard care.
Prior to commencing extracorporeal shockwave lithotripsy, patients will be given the shortened Health Anxiety Inventory score to complete. Following lithotripsy treatment, patients will be given the short form McGill pain questionnaire to complete.
The initial pilot study will aim to recruit sixty patients and further recruitment will take place on the basis of the outcomes of the pilot study.
Inclusion criteria All patients over eighteen years old undergoing extracorporeal shockwave lithotripsy for the first time
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Over 18 years old
- •First ESWL treatment
排除标准
- •Patients not capable of giving informed consent
- •Patients unsuitable for ESWL
研究组 & 干预措施
Stress balls
The first arm will be given stress balls to squeeze during their treatment and will also receive standard care (the offer of oral analgesia)
干预措施: Stress balls (Behavioral)
Headphones
The second arm will be given headphones to listen to music during their treatment and will also receive standard care.
干预措施: Headphones (Behavioral)
Control
The control group will receive standard care (the offer of oral analgesia)
结局指标
主要结局
Pain score
时间窗: At the time of completing lithotripsy treatment (3000 shocks over 40 to 60 minutes)
Patients will complete the short form McGill pain questionnaire, subdivided into 11 sensory descriptors, 4 affective descriptors and a visual analogue score. Sensory and affective descriptors are each rated as 0-3. Sensory minimum score 0/33 (no pain), maximum score 33/33 (maximum pain). Affective minimum score 0/12 (no pain), maximum score 12/12 (maximum pain). Visual analogue score 0 to 10 (0 being no pain and 10 being worst possible pain).
次要结局
- Early cessation of lithotripsy treatment(At the time of completing lithotripsy treatment (3000 shocks over 40 to 60 minutes))
研究者
Cliodhna Browne
Specialist Registrar
University College Hospital Galway