NCT01048164

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2010

Completed
Last Updated

January 5, 2012

Status Verified

January 1, 2012

Enrollment Period

3 months

First QC Date

January 12, 2010

Last Update Submit

January 3, 2012

Conditions

StressFatigueAnxiety

Keywords

MassageRelaxation

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    10 Weeks

Study Arms (3)

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.

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.

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.

Interventions

MassagePROCEDURE

Chair Massage

10 Massages5 Massages

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Individuals that decline to participate in the study.
  • Total Contraindications
  • Acute sprain with swelling
  • Lymphatic cancer
  • Fever
  • Local contraindications:
  • Varicose veins
  • Pregnancy
  • Trapped or pinched nerve (radicular symptoms)
  • Skin abrasions, open wounds
  • Venous thrombus
  • Melanoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • 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.

    PMID: 22196566RESULT

MeSH Terms

Conditions

FatigueAnxiety Disorders

Interventions

Massage

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Shelly R. Keller, R.N., C.N.P.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
OT

Study Record Dates

First Submitted

January 12, 2010

First Posted

January 13, 2010

Study Start

April 1, 2008

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

January 5, 2012

Record last verified: 2012-01

Locations

US(1)