- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04787107
Effectiveness of 10-minute Chair Massage Versus 10-minute Break to Reduce Stress and Improve Well-being
The Effectiveness of a 10-minute Chair Massage Versus 10-minute Break to Reduce Psychological and Physical Stress in Healthcare Workers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The primary purpose of this study is to provide cost-effective interventions for nursing personnel aimed at reducing fatigue and stress within their work environment while improving their overall quality of life. Studies have demonstrated that stress management resources and overall engagement of staff lead to quality outcomes for both staff and patients. There is limited research that examines interventions that can reduce stress perception in nursing. This study will examine the physical and psychological impact of 10-minute massage therapy in comparison to a 10-minute scheduled break weekly over a period of 5 weeks. If the outcomes of the study indicate that either massage therapy or scheduled breaks are an effective intervention for management of stressful situations and improving quality of life, the overall goal would be to create relaxation rooms on more nursing units that allow staff to engage in massage therapy or scheduled rest sessions to reduce stressful work situations.
Studies have indicated that healthcare workers experience high levels of work-related stress that include individual, social, occupational and environmental factors. Unrelieved or mismanaged stressors contribute to a variety of health-related consequences including disturbances in the digestive system, headaches, sleep disturbances, hypertension, fatigue and psychological issues, including anxiety. Massage therapy and scheduled breaks have been identified as potential interventions to mitigate or reduce stress. The use of mechanical massage has been shown to mimic the effects of traditional physical massage in terms of reducing stress and anxiety of the end-users. Mechanical massages have an advantage over physical massages since they are more cost-effective, can be used when convenient, and within a controlled environment. The literature supports that massage therapy can have an impact on reducing stress, anxiety, depression, and pain, while enhancing an individual's immune function, relaxation, and overall well-being. Studies have also indicated that nurses often lack opportunities to take breaks during their scheduled shifts. In many instances, staff sacrifice their breaks in order to fulfill patient-care duties. This study will compare both massage therapy and scheduled breaks to examine the overall impact on healthcare workers.
The COVID-19 pandemic has increased workplace stressors for healthcare workers; however, there is limited evidence to support successful interventions to manage these stressors.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Danville, Pennsylvania, United States, 17822
- Geisinger
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Health care professional assigned work duties on designed unit
- Men and women able age 18-84 able to give informed consent
- Able to speak and understand English
Exclusion Criteria:
- Individuals that decline to participate in the study
- Individuals currently on work restrictions
- Recent head, neck, shoulder or back surgeries
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 10 Minute Chair Massage
Chair massage for 10 minutes once a week for 5 weeks
|
Healthcare staff will be placed into either massage or break intervention
Other Names:
|
|
Experimental: 10 Minute Scheduled Break
Scheduled 10-minute break once a week for 5 weeks
|
Healthcare staff will be placed into either massage or break intervention
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Professional Quality of Life Scores
Time Frame: 5 weeks
|
The change in professional quality of life scores will be compared pre trial and post at completion of 5 weeks
|
5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Heart Rate of 2-arms
Time Frame: 5 weeks
|
Participants will record heart rate pre and post intervention for each session and these measures will be examined for decrease in heartrate and compared amongst both arms
|
5 weeks
|
|
Change in Blood Pressure of 2-arms
Time Frame: 5 weeks
|
Participants will record blood pressure pre and post intervention for each session and these measures will be examined for decrease in blood pressure and compared amongst both arms
|
5 weeks
|
|
Change in Self-reported level of pain on scale of 0-10
Time Frame: 5 weeks
|
Participants will record self-reported pain level pre and post intervention for each session and these measures will be examined for decrease in level of pain and compared amongst both arms.
Participants will use the Geisinger Pain Scale, 0 indicates no pain, 10 would indicate severe pain
|
5 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-0186
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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