CAM in Post Surgical Management in Cardiothoracic Surgery
- Conditions
- Patients Undergoing Lung SurgeryPatients Undergoing Open Heart Surgery
- Interventions
- Other: Acupuncture, homeopathy, osteopathy- and reflexologyDrug: Homeopathic placebo medication
- Registration Number
- NCT01650363
- Lead Sponsor
- Shaare Zedek Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- 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
- patients unable to comply with the study protocol
- Participation in another clinical trial
- Thrombocytopenia (< 15.000 for acupuncture treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Acupuncture, homeopathy, osteopathy and reflexology Acupuncture, homeopathy, osteopathy- and reflexology patients will receive combinations of acupuncture, homeopathy, osteopathy and reflexology homeopathic placebo medication Homeopathic placebo medication -
- Primary Outcome Measures
Name Time Method Improvement of Quality of Recovery questionnaire-40 (QoR-40) 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.
- Secondary Outcome Measures
Name Time Method Analgesia Protocol daily intake of anlagesic medications will be evaluated each evening throughout the study period (mean expected: 4 weeks) Analgesics use
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 Hospitalization duration will be calculated from the first postoperative day. Readiness for discharge will be assessed based on the following measures: Bowel movements and lack of urinary retention yes/no; Ability to dress oneself and move freely; opiate requirement yes/no. Surgical complications requiring further hospitalization yes/no.
Readiness for discharge will be based on a 'YES " for the first 2 measures and a "no" ON THE LAST 2 MEASURES.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) Nausea levels and frequency of vomiting
Food intake participants will be evaluated for the ingestion of the first solid meal (average: 4 days) Duration from surgery to first solid meal
Patient Satisfaction at discharge from hospital; expected mean: 4 weeks Patient satisfaction questionnaire
Immune System Function 2nd and 4th day after treatment initiation - the function of the immune system will be evaluated by measuring IL-2 level on the second and fourth day
Ambulation each day participants will be evaluated for ambulation (expected mean: 1 week) As ambulant will a patient regarded if he will be able to walk 5 minutes without help
Stress levels Study entry, 2nd and 3rd day following the treatment initiation. Level of stress will be determined by Dehydroepiandrosterone (DHES) \& Cortisol levels in blood and, saliva.
Pain level estimation first 3 days and day 6 Pain estimation will be based on the NRS scale. The patient will be asked to rate the highest level of pain experienced during the last 24 hrs.
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 0- 10 scale (0=no fatigue; 10 maximal fatigue)
Trial Locations
- Locations (1)
Dptm. Cardio-Thoracic Surgery, Shaare Zedek medical Center
🇮🇱Jerusalem, Israel