Coronary Artery Bypass Graft SurgeryMT and CABGNCT01095419
Effects of Massage Therapy on Sleep After Heart Surgery
A study testing Massage Therapy in people with Coronary Artery Bypass Graft Surgery, run by University of Sao Paulo at 1 site in Brazil.
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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Coronary Artery Bypass Graft Surgery
- What is being tested?
- Massage Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- May 2008to Jan 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria included patients of both genders, between 40 to 80 years of age which were waiting for Coronary artery bypass graft surgery.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Heart Institute -University of São Paulo School of Medicine
São Paulo, São Paulo, 05403-001
About this study
Official title: 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).
Read the 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.
- Conditions
- Coronary Artery Bypass Graft Surgery
- Being tested
- Massage Therapy, Control
- Keywords
- massage therapy, sleep quality, coronary artery bypass grafting surgery, Patients after Coronary Artery Bypass Graft Surgery
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage TherapyOther
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)
ControlOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients were seated in a chair for the same period then those from MT group, but did not receive intervention Receives: Other: Control |
| Massage Therapy | Experimental | Patients in the postoperative period of coronary artery bypass graft surgery, which receive intervention for 3 consecutive days Receives: Other: Massage Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of Massage Therapy on quality of sleep
Measured: 3 days after return to the ward
Secondary outcomes (1)
Effect of massage therapy on pain and fatigue complaints
Measured: 3 days after return to the ward
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
- Study startMay 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass Graft SurgeryStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação Zerbini
- Investigators
- Flávia B. Nerbass, PT, Principal investigator, University of Sao PauloGeraldo Lorenzi-Filho, MD, PhD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095419
- Sponsor's protocol ID
- MT-CABG
- Acronym
- MT and CABG
- Status last verified
- Mar 2010
- First submitted
- 29 Mar 2010
- Last updated
- 30 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21243280
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Massage Therapy on Sleep Quality After Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT01095419
- Acronym / sponsor ID
- MT and CABG / MT-CABG
- Conditions
- Coronary Artery Bypass Graft Surgery
- Keywords
- massage therapy, sleep quality, coronary artery bypass grafting surgery, Patients after Coronary Artery Bypass Graft Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação Zerbini
- Study start
- May 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 30 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | Other: ControlPatients were seated in a chair for the same period then those from MT group, but did not receive intervention |
| Massage Therapy | Experimental | Other: Massage TherapyPatients in the postoperative period of coronary artery bypass graft surgery, which receive intervention for 3 consecutive days |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria included patients of both genders, between 40 to 80 years of age which were waiting for Coronary artery bypass graft surgery.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Massage TherapyAfter 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) | Other | Massage Therapy |
| Controlno intervention | Other | Control |
Primary outcome
Effects of Massage Therapy on quality of sleep
Time frame: 3 days after return to the ward
1 secondary outcome
Effect of massage therapy on pain and fatigue complaints
Time frame: 3 days after return to the ward
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2010.
- Derived from this study: PubMed 21243280Nerbass 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Flávia B. Nerbass, PT principal investigator
University of Sao Paulo
Geraldo Lorenzi-Filho, MD, PhD study director
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage Therapy in people with Coronary Artery Bypass Graft Surgery, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of Massage Therapy on quality of sleep (time frame: 3 days after return to the ward). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01095419, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2010.