Effect of Complementary and Alternative Medical Methods on the Post Operative Recovery Following Cardio-thoracic Surgery- a Pragmatic, Randomized,Single Blinded, Placebo Controlled Study
Overview
- Phase
- Phase 3
- Intervention
- Acupuncture, homeopathy, osteopathy- and reflexology
- Conditions
- Patients Undergoing Open Heart Surgery
- Sponsor
- Shaare Zedek Medical Center
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Improvement of Quality of Recovery questionnaire-40 (QoR-40)
- Last Updated
- 13 years ago
Overview
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.
Investigators
Menachem Oberbaum
MD
Shaare Zedek Medical Center
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •patients unable to comply with the study protocol
- •Participation in another clinical trial
- •Thrombocytopenia (\< 15.000 for acupuncture treatment
Arms & Interventions
Acupuncture, homeopathy, osteopathy and reflexology
patients will receive combinations of acupuncture, homeopathy, osteopathy and reflexology
Intervention: Acupuncture, homeopathy, osteopathy- and reflexology
homeopathic placebo medication
Intervention: Homeopathic placebo medication
Outcomes
Primary Outcomes
Improvement of Quality of Recovery questionnaire-40 (QoR-40)
Time Frame: 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 Outcomes
- 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)