NCT01095419

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 30, 2010

Completed
Last Updated

March 30, 2010

Status Verified

March 1, 2010

Enrollment Period

8 months

First QC Date

March 29, 2010

Last Update Submit

March 29, 2010

Conditions

Keywords

massage therapysleep qualitycoronary artery bypass grafting surgeryPatients after Coronary Artery Bypass Graft Surgery

Outcome Measures

Primary Outcomes (1)

  • Effects of Massage Therapy on quality of sleep

    3 days after return to the ward

Secondary Outcomes (1)

  • Effect of massage therapy on pain and fatigue complaints

    3 days after return to the ward

Study Arms (2)

Control

NO INTERVENTION

Patients were seated in a chair for the same period then those from MT group, but did not receive intervention

Other: Control

Massage Therapy

EXPERIMENTAL

Patients in the postoperative period of coronary artery bypass graft surgery, which receive intervention for 3 consecutive days

Other: Massage Therapy

Interventions

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)

Massage Therapy
ControlOTHER

no intervention

Control

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Institute -University of São Paulo School of Medicine

São Paulo, São Paulo, 05403-001, Brazil

Location

Related Publications (1)

  • Nerbass FB, Feltrim MI, Souza SA, Ykeda DS, Lorenzi-Filho G. Effects of massage therapy on sleep quality after coronary artery bypass graft surgery. Clinics (Sao Paulo). 2010;65(11):1105-10. doi: 10.1590/s1807-59322010001100008.

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Massage

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Flávia B. Nerbass, PT

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR
  • Geraldo Lorenzi-Filho, MD, PhD

    University of Sao Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 29, 2010

First Posted

March 30, 2010

Study Start

May 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

March 30, 2010

Record last verified: 2010-03

Locations