CAM in Post Surgical Management in Cardiothoracic Surgery

Shaare Zedek Medical Center

Status and phase: Unknown; Phase 3

Conditions: Patients Undergoing Open Heart Surgery; Patients Undergoing Lung Surgery

Treatments: Other: Acupuncture, homeopathy, osteopathy- and reflexology; Drug: Homeopathic placebo medication

Study type: Interventional

Funder types: Other

Identifiers

NCT01650363

CTSURG

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Acupuncture, homeopathy, osteopathy and reflexology

Active Comparator group

Description:

patients will receive combinations of acupuncture, homeopathy, osteopathy and reflexology

Treatment:

Other: Acupuncture, homeopathy, osteopathy- and reflexology

homeopathic placebo medication

Placebo Comparator group

Treatment:

Drug: Homeopathic placebo medication