Clinical trial NCT01095419: Effects of Massage Therapy on Sleep After Heart Surgery
Official title: Effects of Massage Therapy on Sleep Quality After Coronary Artery Bypass Graft Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Bypass Graft Surgery
Keywords: massage therapy
sleep quality
coronary artery bypass grafting surgery
Patients after Coronary Artery Bypass Graft Surgery
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação Zerbini
First posted: 2010-03-30
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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

Primary outcomes:
measure: Effects of Massage Therapy on quality of sleep
timeFrame: 3 days after return to the ward
Secondary outcomes:
measure: Effect of massage therapy on pain and fatigue complaints
timeFrame: 3 days after return to the ward
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Heart Institute -University of São Paulo School of Medicine
Study officials:
affiliation: University of Sao Paulo
name: Flávia B. Nerbass, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Geraldo Lorenzi-Filho, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.