Usefulness of Integrative Medicine Tools As Adjunctive Care for Women After Coronary Artery Bypass Grafting

NCT01020227 | Completed Phase 1

• 1 other identifier: AAAB1732
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Background: This randomized controlled trial investigates the effectiveness of an Integrative Therapies (IT) health education intervention in improving physical and psychological functioning in female patients after coronary artery bypass graft (CABG). Methods: One hundred female cardiac surgery patients were assigned to either an intervention or standard care control group. Patients in the intervention group were given a cardiac yoga video, a guided imagery audiotape, instruction in diaphragmatic breathing, and an educational booklet outlining recommendations for dietary change. Patients were followed for 6 months by a health educator who provided ongoing education and encouragement and were assessed at 6 weeks and 6 months post surgery to determine between group differences on physical functioning and psychological distress using the SF-36 and the Profile of Mood States

Conditions

Cardiovascular Disease

Keywords

Postoperative Care; Quality of Life; Integrative Medicine; Coronary Artery Bypass Graft Surgery

Outcome Measures

Primary Outcomes (1)

• Self reported psychosocial adjustment

  6 weeks and 6 months post surgery

Secondary Outcomes (1)

• Self reported physical functioning and clinical cardiovascular outcomes

  6 weeks and 6 months post surgery

Study Arms (2)

Integrative Therapies

EXPERIMENTAL

Patients in the intervention group were given a cardiac yoga video, a guided imagery audiotape, instruction in diaphragmatic breathing, and an educational booklet outlining recommendations for dietary change. Patients were followed for 6 months by a health educator who provided ongoing education and encouragement

Behavioral: Integrative Therapies Intervention

Standard Care

NO INTERVENTION

Patients were given no intervention but were contacted at 6 weeks and 6 months for data collection purposes

Interventions

Integrative Therapies Intervention BEHAVIORAL

Patients in the intervention group were given a cardiac yoga video, a guided imagery audiotape, instruction in diaphragmatic breathing, and an educational booklet outlining recommendations for dietary change. Patients were followed for 6 months by a health educator who provided ongoing education and encouragement

Integrative Therapies

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patient
• Undergoing CABG or Valve Surgery

You may not qualify if:

• Non-English speaking
• No home phone

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Erin L Olivo, PhD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

• Mehmet C Oz, MD

  Columbia University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor of Medical Psychology ( In Psychiatry)

Study Record Dates

• First Submitted: November 23, 2009
• First Posted: November 25, 2009
• Study Start: February 1, 2004
• Study Completion: December 1, 2007
• Last Updated: January 29, 2014

Record last verified: 2014-01

Locations

US (1)