NCT01650363

CAM in Post Surgical Management in Cardiothoracic Surgery

Effect of Complementary and Alternative Medical Methods on the Post Operative Recovery Following Cardio-thoracic Surgery- a Pragmatic, Randomized,Single Blinded, Placebo Controlled Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Shaare Zedek Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Patients Undergoing Open Heart Surgery
• Patients Undergoing Lung Surgery

Interventions

Type	Name	Description
OTHER	Acupuncture, homeopathy, osteopathy- and reflexology	a combination of the above mentioned treatments
DRUG	Homeopathic placebo medication	2-3 mm small spheric suger pils

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2012-07-26
• Last updated: 2012-07-26

Locations

1 site across 1 country: Israel