Patients Undergoing Lung Surgery Clinical Trial
Official title:
Effect of Complementary and Alternative Medical Methods on the Post Operative Recovery Following Cardio-thoracic Surgery- a Pragmatic, Randomized,Single Blinded, Placebo Controlled Study
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment