Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Effects of Massage Therapy on Sleep After Heart Surgery (MT and CABG)

This study has been completed.
Sponsor:
Collaborator:
Fundação Zerbini
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01095419
First received: March 29, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose
The purpose of this study is to evaluate the effects of Massage Therapy for improving the quality of sleep in patients on postoperative period of coronary artery bypass graft surgery (CABG).

Condition Intervention
Coronary Artery Bypass Graft Surgery
Other: Massage Therapy
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Massage Therapy on Sleep Quality After Coronary Artery Bypass Graft Surgery

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Effects of Massage Therapy on quality of sleep [ Time Frame: 3 days after return to the ward ]

Secondary Outcome Measures:
  • Effect of massage therapy on pain and fatigue complaints [ Time Frame: 3 days after return to the ward ]

Enrollment: 40
Study Start Date: May 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Patients were seated in a chair for the same period then those from MT group, but did not receive intervention
Other: Control
no intervention
Experimental: Massage Therapy
Patients in the postoperative period of coronary artery bypass graft surgery, which receive intervention for 3 consecutive days
Other: Massage Therapy
After discharge from the intensive care unit to the ward during the postoperative period, patients which were randomized for 3 nights to receive intervention (Massage Therapy)which were consisted of massage of the neck, shoulders, and back. The massage was initiated with light manual compression and progressed to deep compression. The compression was performed with the inner region of the fingers, hand-shaped clamp, and friction (digital compression with the thumb) on trigger points, cervical traction, and mobilization in all planes (front, back, and sides)

Detailed Description:

Patients We evaluated patients admitted to the ward waiting for elective CABG surgery.

Preoperative evaluation The preoperative clinical assessment consisted of obtaining information regarding demographics and personal characteristics.

Postoperative protocol and evaluation After discharge from the intensive care unit to the ward during the postoperative period, the patients were randomized to 3 nights of sitting for 10 minutes, with no intervention (Control) or to MT. Briefly, MT consisted of massage of the neck, shoulders, and back. The massage was initiated with light manual compression and progressed to deep compression. The compression was performed with the inner region of the fingers, hand-shaped clamp, and friction (digital compression with the thumb) on trigger points, cervical traction, and mobilization in all planes (front, back, and sides). The massage was finished with light manual compression. During the study period, all patients completed a sleep diary containing the time they went to sleep, woke up, and took daytime naps. The patients completed a VAS for pain and fatigue (similar to the preoperative evaluation described previously) as well as a VAS for sleep on days 1, 2, and 3, corresponding to the morning following the intervention that was performed on the previous night.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion criteria included patients of both genders, between 40 to 80 years of age which were waiting for Coronary artery bypass graft surgery.

Exclusion Criteria:

  • Patients with body mass index (BMI) ≥35kg/m2
  • Regular alcohol consumption
  • Chronic use of hypnotics
  • A previous diagnosis of sleep disorders
  • Previous surgeries performed in the last 24 months
  • The inability to read and write. We also excluded patients who underwent valve surgery combined with CABG, the presence of a thoracic drain, and ICU stay longer than 5 days in the postoperative period
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01095419

Locations
Brazil
Heart Institute -University of São Paulo School of Medicine
São Paulo, Brazil, 05403-001
Sponsors and Collaborators
University of Sao Paulo
Fundação Zerbini
Investigators
Principal Investigator: Flávia B. Nerbass, PT University of Sao Paulo
Study Director: Geraldo Lorenzi-Filho, MD, PhD University of Sao Paulo
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Effects of Massage Therapy on Sleep Quality after Coronary Artery Bypass Graft Surgery
ClinicalTrials.gov Identifier: NCT01095419     History of Changes
Other Study ID Numbers: MT-CABG
Study First Received: March 29, 2010
Last Updated: March 29, 2010

Keywords provided by University of Sao Paulo:
massage therapy
sleep quality
coronary artery bypass grafting surgery
Patients after Coronary Artery Bypass Graft Surgery

ClinicalTrials.gov processed this record on May 25, 2017