StressNCT01048164
Measuring the Effect of Therapeutic Massage on Pain and Discomfort in Cardiac Cath Lab Staff
A study testing Massage in people with Stress and Fatigue, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of therapeutic massage in alleviating musculoskeletal pain and discomfort associated with wearing lead aprons in the cardiac cath lab. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Massage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jul 2008
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnostic and interventional cardiology staff including:
- cardiologists
- cardiology fellows
- nurses
- technical staff
- and a core group of CRNA's employed by the Cardiac Catheterization Laboratory.
- These staff members, per their job descriptions, wear lead aprons while caring for patients during the weeks of the massage therapy pilot study.
Who cannot join
- Individuals that decline to participate in the study.
- Massage therapy has contraindications that require a physician's order before the therapist is allowed to see the person for massage. The following total contraindications will be total exclusions for this study unless the individual gains a physician's order that negates the exclusions or defines it to a local contraindication.
- Total Contraindications
- Acute sprain with swelling
- Lymphatic cancer
- Fever
Show all 14Show fewer
- Local Contraindications do not exclude the person from the study. These are area exclusions that disallow the therapist to work on a specific part of the body and/or the therapist needs to adjust techniques. The therapist will track all local contraindications.
- Local contraindications:
- Varicose veins
- Pregnancy
- Trapped or pinched nerve (radicular symptoms)
- Skin abrasions, open wounds
- Venous thrombus
- Melanoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measuring the Effect of Therapeutic Massage on Pain and Discomfort in Cardiac Cath Lab Staff - A Pilot Study
The purpose of this study is to evaluate the effect of therapeutic massage in alleviating musculoskeletal pain and discomfort associated with wearing lead aprons in the cardiac cath lab. We also want to evaluate if therapeutic massage will reduce fatigue, stress, and anxiety while improving the level of relaxation in cardiac cath lab employees who wear lead aprons.
Read the detailed description
The cardiac catheterization laboratory is a very dynamic work environment. The physical and psychosocial demands of the work environment place a significant amount of stress on the physical well being of the employee. The nature of the work involved includes that of responding to rapidly changing patient clinical conditions which are often urgent, and require repetitive actions in an ergonomically challenging environment. In addition, employees who are directly exposed to the radiation required to perform diagnostic and interventional procedures wear lead aprons weighing on average 10-15 pounds.
A constant build-up of tension in the muscles from regular, repetitive activity may lead to stresses on the muscles, joints, ligaments and tendons. Adding to this, working while wearing lead aprons, with elements of repetitive use and non-optimal ergonomic situations, Cardiac Cath Lab employees are at higher risk for muscle imbalances. The accumulation of tension and imbalance leads to joint wearing and muscle fatigue that result in injuries. Massage therapy, applied skillfully, is one of the most effective forms of therapy for releasing muscle tension, restoring balance to the musculoskeletal system, while creating awareness of musculoskeletal balance in the employee. Massage provided regularly may help employees prevent injuries caused by overuse.
As muscle imbalances develop they often go undiagnosed until they are serious enough to cause the employee discomfort or impede performance. Frequently the discomfort is masked with pain medications and ultimately leads to injuries. A skilled massage therapist will detect variations in the soft tissues and by using the correct techniques, help the employee maintain a much healthier physical state and prevent injury.
Massage therapy is purported to affect both the structure and function of the musculoskeletal system by promoting the relaxation response and reducing muscle tension and fatigue while improving posture. Given the potential benefits of massage therapy, many work environments are implementing massage therapy programs to improve the health and well being of their employees.
- Being tested
- Massage
- Keywords
- Massage, Relaxation
- Medical subject headings
- Fatigue, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MassageProcedure or surgery
Chair Massage
| Study group | Role | What they receive |
|---|---|---|
| 10 Massages | Active comparator | This group consists of individuals that wear lead aprons, and they will receive ten, 30-minute scheduled massage appointments during the hours the participant is working in the cardiac lab, over a 10 week period. Receives: Procedure: Massage |
| 5 Massages | Active comparator | This group consists of individuals that wear lead aprons, and they will receive five, 30-minute scheduled massage appointments, during the hours the participant is working in the cardiac lab, over a 5 week period. This arm will not receive massages for the first 5 weeks and then will receive their massages during the second 5 week period. Receives: Procedure: Massage |
| Control Group | No intervention | This group will consist of those individuals that wear lead aprons with no desire to participate in the massage study yet are willing to provide information through questionnaires. They will be given the same questionnaire as those in the two massage therapy arms of the study, at the beginning, middle, and end of study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare and contrast the level of pain and discomfort in staff that wear lead aprons at baseline, end of first 5-weeks of massage therapy, end of the second 5-weeks of massage therapy and to those that do not get massage during that same period.
Measured: 10 Weeks
Secondary outcomes (1)
Compare the level of stress, anxiety, and relaxation in staff that wear lead aprons, at baseline, end of first 5-weeks of massage therapy, end of the second 5-weeks of massage therapy and to those that do not get massage during that same period.
Measured: 10 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startApr 2008
- Primary completionJul 2008
- Study completionJul 2008
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 StressStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Engen, Mayo Clinic
- Investigators
- Shelly R. Keller, R.N., C.N.P., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048164
- Sponsor's protocol ID
- 08-000190
- Status last verified
- Jan 2012
- First submitted
- 12 Jan 2010
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Keller SR, Engen DJ, Bauer BA, Holmes DR Jr, Rihal CS, Lennon RJ, Loehrer LL, Wahner-Roedler DL. Feasibility and effectiveness of massage therapy for symptom relief in cardiac catheter laboratory staff: a pilot study. Complement Ther Clin Pract. 2012 Feb;18(1):4-9. doi: 10.1016/j.ctcp.2011.08.006. Epub 2011 Sep 23.
PubMed 22196566
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Effect of Therapeutic Massage on Pain and Discomfort in Cardiac Cath Lab Staff - A Pilot Study
- ClinicalTrials.gov ID
- NCT01048164
- Acronym / sponsor ID
- 08-000190
- Keywords
- Massage, Relaxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 13 Jan 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 effect of therapeutic massage in alleviating musculoskeletal pain and discomfort associated with wearing lead aprons in the cardiac cath lab. We also want to evaluate if therapeutic massage will reduce fatigue, stress, and anxiety while improving the level of relaxation in cardiac cath lab employees who wear lead aprons.
Detailed description
The cardiac catheterization laboratory is a very dynamic work environment. The physical and psychosocial demands of the work environment place a significant amount of stress on the physical well being of the employee. The nature of the work involved includes that of responding to rapidly changing patient clinical conditions which are often urgent, and require repetitive actions in an ergonomically challenging environment. In addition, employees who are directly exposed to the radiation required to perform diagnostic and interventional procedures wear lead aprons weighing on average 10-15 pounds.
A constant build-up of tension in the muscles from regular, repetitive activity may lead to stresses on the muscles, joints, ligaments and tendons. Adding to this, working while wearing lead aprons, with elements of repetitive use and non-optimal ergonomic situations, Cardiac Cath Lab employees are at higher risk for muscle imbalances. The accumulation of tension and imbalance leads to joint wearing and muscle fatigue that result in injuries. Massage therapy, applied skillfully, is one of the most effective forms of therapy for releasing muscle tension, restoring balance to the musculoskeletal system, while creating awareness of musculoskeletal balance in the employee. Massage provided regularly may help employees prevent injuries caused by overuse.
As muscle imbalances develop they often go undiagnosed until they are serious enough to cause the employee discomfort or impede performance. Frequently the discomfort is masked with pain medications and ultimately leads to injuries. A skilled massage therapist will detect variations in the soft tissues and by using the correct techniques, help the employee maintain a much healthier physical state and prevent injury.
Massage therapy is purported to affect both the structure and function of the musculoskeletal system by promoting the relaxation response and reducing muscle tension and fatigue while improving posture. Given the potential benefits of massage therapy, many work environments are implementing massage therapy programs to improve the health and well being of their employees.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 10 Massages | Active comparator | Procedure: MassageThis group consists of individuals that wear lead aprons, and they will receive ten, 30-minute scheduled massage appointments during the hours the participant is working in the cardiac lab, over a 10 week period. |
| 5 Massages | Active comparator | Procedure: MassageThis group consists of individuals that wear lead aprons, and they will receive five, 30-minute scheduled massage appointments, during the hours the participant is working in the cardiac lab, over a 5 week period. This arm will not receive massages for the first 5 weeks and then will receive their massages during the second 5 week period. |
| Control Group | No intervention | –This group will consist of those individuals that wear lead aprons with no desire to participate in the massage study yet are willing to provide information through questionnaires. They will be given the same questionnaire as those in the two massage therapy arms of the study, at the beginning, middle, and end of study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- cardiologists
- cardiology fellows
- nurses
- technical staff
- and a core group of CRNA's employed by the Cardiac Catheterization Laboratory.
Key exclusion criteria (14 listed)
- Individuals that decline to participate in the study.
- Massage therapy has contraindications that require a physician's order before the therapist is allowed to see the person for massage. The following total contraindications will be total exclusions for this study unless the individual gains a physician's order that negates the exclusions or defines it to a local contraindication.
- Total Contraindications
- Acute sprain with swelling
- Lymphatic cancer
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 |
|---|---|---|
| MassageChair Massage | Procedure or surgery | 10 Massages, 5 Massages |
Primary outcome
Compare and contrast the level of pain and discomfort in staff that wear lead aprons at baseline, end of first 5-weeks of massage therapy, end of the second 5-weeks of massage therapy and to those that do not get massage during that same period.
Time frame: 10 Weeks
1 secondary outcome
Compare the level of stress, anxiety, and relaxation in staff that wear lead aprons, at baseline, end of first 5-weeks of massage therapy, end of the second 5-weeks of massage therapy and to those that do not get massage during that same period.
Time frame: 10 Weeks
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 5 Jan 2012.
- Results publication: PubMed 22196566Keller SR, Engen DJ, Bauer BA, Holmes DR Jr, Rihal CS, Lennon RJ, Loehrer LL, Wahner-Roedler DL. Feasibility and effectiveness of massage therapy for symptom relief in cardiac catheter laboratory staff: a pilot study. Complement Ther Clin Pract. 2012 Feb;18(1):4-9. doi: 10.1016/j.ctcp.2011.08.006. Epub 2011 Sep 23.
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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.
Shelly R. Keller, R.N., C.N.P. principal investigator
Mayo Clinic
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 in people with Stress and Fatigue, run by Mayo Clinic at 1 site in United States.
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 7 inclusion and 14 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 5 Jan 2012. 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 United States. 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?
Compare and contrast the level of pain and discomfort in staff that wear lead aprons at baseline, end of first 5-weeks of massage therapy, end of the second 5-weeks of massage therapy and to those that do not get massage during that same period. (time frame: 10 Weeks). 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 NCT01048164, 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 5 Jan 2012.