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

March 29, 2010 updated by: University of Sao Paulo

Effects of Massage Therapy on Sleep Quality After Coronary Artery Bypass Graft Surgery

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403-001
        • Heart Institute -University of São Paulo School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effects of Massage Therapy on quality of sleep
Time Frame: 3 days after return to the ward
3 days after return to the ward

Secondary Outcome Measures

Outcome Measure
Time Frame
Effect of massage therapy on pain and fatigue complaints
Time Frame: 3 days after return to the ward
3 days after return to the ward

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Fundação Zerbini

Investigators

  • Principal Investigator: Flávia B. Nerbass, PT, University of Sao Paulo
  • Study Director: Geraldo Lorenzi-Filho, MD, PhD, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

March 29, 2010

First Submitted That Met QC Criteria

March 29, 2010

First Posted (Estimate)

March 30, 2010

Study Record Updates

Last Update Posted (Estimate)

March 30, 2010

Last Update Submitted That Met QC Criteria

March 29, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MT-CABG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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