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

Primary Purpose

Stress, Fatigue, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Massage
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress focused on measuring Massage, Relaxation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

10 Massages

5 Massages

Control Group

Arm Description

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.

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.

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.

Outcomes

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.

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.

Full Information

First Posted
January 12, 2010
Last Updated
January 3, 2012
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01048164
Brief Title
Measuring the Effect of Therapeutic Massage on Pain and Discomfort in Cardiac Cath Lab Staff
Official Title
Measuring the Effect of Therapeutic Massage on Pain and Discomfort in Cardiac Cath Lab Staff - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Fatigue, Anxiety
Keywords
Massage, Relaxation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10 Massages
Arm Type
Active Comparator
Arm Description
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.
Arm Title
5 Massages
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Massage
Intervention Description
Chair Massage
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shelly R. Keller, R.N., C.N.P.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22196566
Citation
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.
Results Reference
result

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

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