Measuring the Effect of Therapeutic Massage on Pain and Discomfort in Cardiac Cath Lab Staff
| Tracking Information | |||||
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| First Received Date ICMJE | January 12, 2010 | ||||
| Last Updated Date | January 3, 2012 | ||||
| Start Date ICMJE | April 2008 | ||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01048164 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Measuring the Effect of Therapeutic Massage on Pain and Discomfort in Cardiac Cath Lab Staff | ||||
| Official Title ICMJE | Measuring the Effect of Therapeutic Massage on Pain and Discomfort in Cardiac Cath Lab Staff - A Pilot Study | ||||
| Brief 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. 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: Massage
Chair Massage |
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| Study Arm (s) |
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| 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. Epub 2011 Sep 23. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 60 | ||||
| Completion Date | July 2008 | ||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Diagnostic and interventional cardiology staff including:
These staff members, per their job descriptions, wear lead aprons while caring for patients during the weeks of the massage therapy pilot study. Exclusion Criteria:
Total Contraindications
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:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01048164 | ||||
| Other Study ID Numbers ICMJE | 08-000190 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Deborah Engen, Mayo Clinic | ||||
| Study Sponsor ICMJE | Mayo Clinic | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Mayo Clinic | ||||
| Verification Date | January 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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