Effects of Massage Therapy on Sleep After Heart Surgery

Coronary Artery Bypass Graft Surgery Clinical Trial

— MT and CABG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01095419
• Other study ID #: MT-CABG
• Status: Completed
• Phase: N/A
• First received: March 29, 2010
• Last updated: March 29, 2010
• Start date: May 2008
• Est. completion date: January 2009

Study information

• Verified date: March 2010
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Bypass Graft Surgery

Intervention

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)
• Control
no intervention

Locations

Country	Name	City	State
Brazil	Heart Institute -University of São Paulo School of Medicine	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação Zerbini

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of Massage Therapy on quality of sleep		3 days after return to the ward	Yes
Secondary	Effect of massage therapy on pain and fatigue complaints		3 days after return to the ward	Yes