Effects of Massage Therapy on Sleep After Heart Surgery

NCT ID: NCT01095419

Last Updated: 2010-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-01-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Coronary Artery Bypass Graft Surgery

Keywords

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massage therapy sleep quality coronary artery bypass grafting surgery Patients after Coronary Artery Bypass Graft Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type NO_INTERVENTION

Control

Intervention Type OTHER

no intervention

Massage Therapy

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

Group Type EXPERIMENTAL

Massage Therapy

Intervention Type OTHER

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)

Interventions

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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)

Intervention Type OTHER

Control

no intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação Zerbini

UNKNOWN

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Principal Investigators

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Flávia B. Nerbass, PT

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Geraldo Lorenzi-Filho, MD, PhD

Role: STUDY_DIRECTOR

University of Sao Paulo

Locations

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Heart Institute -University of São Paulo School of Medicine

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 21243280 (View on PubMed)

Other Identifiers

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MT-CABG

Identifier Type: -

Identifier Source: org_study_id