Measuring the Effect of Therapeutic Massage on Pain and Discomfort in Cardiac Cath Lab Staff

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Deborah Engen, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01048164
First received: January 12, 2010
Last updated: January 3, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Stress
Fatigue
Anxiety
Procedure: Massage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Measuring the Effect of Therapeutic Massage on Pain and Discomfort in Cardiac Cath Lab Staff - A Pilot Study

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: April 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 10 Massages
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.
Procedure: Massage
Chair Massage
Active Comparator: 5 Massages
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.
Procedure: Massage
Chair Massage
No Intervention: Control Group
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01048164

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Shelly R. Keller, R.N., C.N.P. Mayo Clinic
  More Information

Publications:
Responsible Party: Deborah Engen, OT, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01048164     History of Changes
Other Study ID Numbers: 08-000190
Study First Received: January 12, 2010
Last Updated: January 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Massage
Relaxation

ClinicalTrials.gov processed this record on October 23, 2014