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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
a combination of the above mentioned treatments
2-3 mm small spheric suger pils
Dptm. Cardio-Thoracic Surgery, Shaare Zedek medical Center
Jerusalem, Israel
Improvement of Quality of Recovery questionnaire-40 (QoR-40)
Quality of Recovery questionnaire is a tool which is used primarily to assess the patient's recovery and state of health following surgery.
Time frame: days 3,5 and 7
Stress levels
Level of stress will be determined by Dehydroepiandrosterone (DHES) \& Cortisol levels in blood and, saliva.
Time frame: Study entry, 2nd and 3rd day following the treatment initiation.
Immune System Function
\- the function of the immune system will be evaluated by measuring IL-2 level on the second and fourth day
Time frame: 2nd and 4th day after treatment initiation
Length of Stay
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.
Time frame: 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.
Time frame: the time to the first passage of flatus and bowel movements, an expected average of 3 days
GI Symptoms
Nausea levels and frequency of vomiting
Time frame: patients will be evaluated for GI symptoms until discharge (expected average 4 weeks)
Food intake
Duration from surgery to first solid meal
Time frame: participants will be evaluated for the ingestion of the first solid meal (average: 4 days)
Analgesia Protocol
Analgesics use
Time frame: daily intake of anlagesic medications will be evaluated each evening throughout the study period (mean expected: 4 weeks)
Pain level estimation
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.
Time frame: first 3 days and day 6
Fatigue
0- 10 scale (0=no fatigue; 10 maximal fatigue)
Time frame: Daily at 3rd, 4th and 5th post operative days 3,4 and 5
Ambulation
As ambulant will a patient regarded if he will be able to walk 5 minutes without help
Time frame: each day participants will be evaluated for ambulation (expected mean: 1 week)
Patient Satisfaction
Patient satisfaction questionnaire
Time frame: at discharge from hospital; expected mean: 4 weeks
Hospitalization costs
Time frame: At hospital discharge (mean expected: 4 weeks)
Postoperative complications
Time frame: Every day, to be evaluated each evening throughout the hospital stay (mean expected: 4 weeks)
Side-effects
Time frame: every day; to be evaluated each evening throughout the study period (mean expected: 4 weeks)
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