Effect of Complementary and Alternative Medical Methods on the Post Operative Recovery Following Cardio-thoracic Surgery- a Pragmatic, Randomized,Single Blinded, Placebo Controlled Study
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Improvement of Quality of Recovery questionnaire-40 (QoR-40)
研究概览
简要总结
This is a randomized controlled clinical trial in which the combination of 4 different CAM modalities (Complementary & Alternative Medicine) will be applied during the postoperative period to patients undergoing open heart- or lung surgery and expected to be hospitalized for more than 5 days.
Elective and Urgent surgical patients will be randomly assigned to a treatment - and to a control group. The treatment group will be treated with a combination of 4 different CAM modalities (Homeopathy, Osteopathy, and Acupuncture & Reflexology) . The control group will be treated with Homeopathic placebo medication.
The main Outcome measurement in the study will be the Quality of recovery 40 questionnaire (QoR- 40) that will be filled out on postoperative days: 3, 5, and 7 respectively. Secondary outcome measurements will be Blood &Saliva Cortisol levels, DHES levels in the blood as surrogates of stress, IL-2 levels as measures of the immune system. Further parameters to be measured include: LOS (length of stay), Level of Pain, mobility, level of satisfaction, GI symptoms (nausea, first bowel movement), post-operative complications& side effects.
All patients participating in the trial will sign an informed consent form . The trial is expected to be conducted over a period of 12 months. Prior to the trial a pilot study will be conducted on a group of 30 patients in order to determine the needed sample size for the trial.
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
- •Over 18 years of age
- •Patients planned to undergo a surgical procedure which will require an estimated hospitalisation of at least 5 days
- •Patients speaking Hebrew or English
- •Informed Consent signature
排除标准
- •patients unable to comply with the study protocol
- •Participation in another clinical trial
- •Thrombocytopenia (< 15.000 for acupuncture treatment
研究组 & 干预措施
Acupuncture, homeopathy, osteopathy and reflexology
patients will receive combinations of acupuncture, homeopathy, osteopathy and reflexology
干预措施: Acupuncture, homeopathy, osteopathy- and reflexology (Other)
homeopathic placebo medication
干预措施: Homeopathic placebo medication (Drug)
结局指标
主要结局
Improvement of Quality of Recovery questionnaire-40 (QoR-40)
时间窗: days 3,5 and 7
Quality of Recovery questionnaire is a tool which is used primarily to assess the patient's recovery and state of health following surgery.
次要结局
- Analgesia Protocol(daily intake of anlagesic medications will be evaluated each evening throughout the study period (mean expected: 4 weeks))
- Side-effects(every day; to be evaluated each evening throughout the study period (mean expected: 4 weeks))
- Length of Stay(patients will be followed for the duration of the hospital stay, an expected average of 4 weeks)
- First postoperative passage of flatus and first bowel movement.(the time to the first passage of flatus and bowel movements, an expected average of 3 days)
- GI Symptoms(patients will be evaluated for GI symptoms until discharge (expected average 4 weeks))
- Food intake(participants will be evaluated for the ingestion of the first solid meal (average: 4 days))
- Patient Satisfaction(at discharge from hospital; expected mean: 4 weeks)
- Immune System Function(2nd and 4th day after treatment initiation)
- Ambulation(each day participants will be evaluated for ambulation (expected mean: 1 week))
- Stress levels(Study entry, 2nd and 3rd day following the treatment initiation.)
- Pain level estimation(first 3 days and day 6)
- Hospitalization costs(At hospital discharge (mean expected: 4 weeks))
- Postoperative complications(Every day, to be evaluated each evening throughout the hospital stay (mean expected: 4 weeks))
- Fatigue(Daily at 3rd, 4th and 5th post operative days 3,4 and 5)
研究者
Menachem Oberbaum
MD
Shaare Zedek Medical Center