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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04787107
Other study ID # 2021-0186
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 30, 2021
Est. completion date February 28, 2023

Study information

Verified date March 2023
Source Geisinger Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine the effectiveness of 10-minute chair massage therapy in comparison to a scheduled 10-minute break to evaluate the impact on perceived quality of life, heart rate, blood pressure, and pain scale in healthcare workers.


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date February 28, 2023
Est. primary completion date January 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 84 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Mechanical Chair Massage
Healthcare staff will be placed into either massage or break intervention

Locations

Country Name City State
United States Geisinger Danville Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Geisinger Clinic Tami Underhill

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Professional Quality of Life Scores The change in professional quality of life scores will be compared pre trial and post at completion of 5 weeks 5 weeks
Secondary Change in Heart Rate of 2-arms 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
Secondary Change in Blood Pressure of 2-arms 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
Secondary Change in Self-reported level of pain on scale of 0-10 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
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