Patient Reported Outcomes Following Complementary Medicine Treatments in Hospitalized Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Perioperative Anxiety Expressed in Visual Analogue Scale for Anxiety (VAS-A) From 0 (Asymptomatic: no Anxiety) to 10 Extremely Symptomatic Anxiety
研究概览
简要总结
This is a randomized, single blinded, interventional trial conducted in patients undergoing elective laparoscopic cholecystectomy, comparing the following three groups: Controls receiving standard-of-care (SoC) only (Group 1); intervention group receiving reflexology and SoC (Group 2); and a group receiving sham reflexology and SoC (Group 3). In all groups, level of preoperative anxiety was evaluated at entry and exit from the Holding Room Area (HRA). The evaluation was carried out using the Visual Analogue Scale for Anxiety (VAS-A) questionnaire.
详细描述
Symptomatic patients are referred to CAM treatments by the medical staff of the departments. Patients interested in CAM treatments may receive various CAM treatments such as reflexology, acupuncture, guided imagery and hypnosis, according to patient preference and practitioner availability. Patients are requested to grade the severity of their symptoms on a visual analogue scale (0-100) before treatment and within 3 hours following treatments. Patients who are interested in standard care alone and not interested in CAM treatments grade their symptoms similarly, and serve as a control group. Primary outcomes are symptomatic relief and secondary outcomes are correlations between belief or disbelief in CAM with the primary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years
- •Undergoing Laparoscopic Cholecysyectomy (LC)
排除标准
- •Patients with a history of obstructive sleep apnea
- •Contraindication for benzodiazepines
- •Hemodynamic instability
- •Patients undergoing a LC together with another surgical procedure.
研究组 & 干预措施
Reflexology
Symptomatic hospitalized people randomized to reflexology on top of standard of care
干预措施: Reflexology (Other)
Standard of care only
Symptomatic hospitalized people randomized to standard of care only
Sham reflexology
Symptomatic hospitalized people randomized to sham reflexology on top of standard of care
干预措施: Sham reflexology (Other)
结局指标
主要结局
Perioperative Anxiety Expressed in Visual Analogue Scale for Anxiety (VAS-A) From 0 (Asymptomatic: no Anxiety) to 10 Extremely Symptomatic Anxiety
时间窗: Baseline and 4 hours post treatment: calculated as value at 4 hours post treatment minus value at baseline
Change of VAS-A between baseline and 4 hours post-treatment
次要结局
未报告次要终点