Stress, PsychologicalNCT04787107
Effectiveness of 10-minute Chair Massage Versus 10-minute Break to Reduce Stress and Improve Well-being
A study testing Mechanical Chair Massage in people with Stress, Psychological and Fatigue, run by Geisinger Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Fatigue, Quality of Life
- What is being tested?
- Mechanical Chair Massage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2021to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Individuals that decline to participate in the study
- Individuals currently on work restrictions
- Recent head, neck, shoulder or back surgeries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of a 10-minute Chair Massage Versus 10-minute Break to Reduce Psychological and Physical Stress in Healthcare Workers
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.
Read the 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.
- Conditions
- Stress, Psychological, Fatigue, Quality of Life
- Being tested
- Mechanical Chair Massage
- Medical subject headings
- Stress, Psychological, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical Chair MassageDevice
Also called Schedule Break
Healthcare staff will be placed into either massage or break intervention
| Study group | Role | What they receive |
|---|---|---|
| 10 Minute Chair Massage | Experimental | Chair massage for 10 minutes once a week for 5 weeks Receives: Device: Mechanical Chair Massage |
| 10 Minute Scheduled Break | Experimental | Scheduled 10-minute break once a week for 5 weeks Receives: Device: Mechanical Chair Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 weeks
Secondary outcomes (3)
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
Measured: 5 weeks
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
Measured: 5 weeks
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
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start30 Aug 2021
- Primary completion31 Jan 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Tami Underhill
- Responsible party
- Principal investigator, Sarah A. Evans, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787107
- Sponsor's protocol ID
- 2021-0186
- Status last verified
- Mar 2023
- First submitted
- 23 Feb 2021
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a 10-minute Chair Massage Versus 10-minute Break to Reduce Psychological and Physical Stress in Healthcare Workers
- ClinicalTrials.gov ID
- NCT04787107
- Acronym / sponsor ID
- 2021-0186
- Conditions
- Stress, Psychological, Fatigue, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Collaborators
- Tami Underhill
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 Minute Chair Massage | Experimental | Device: Mechanical Chair MassageChair massage for 10 minutes once a week for 5 weeks |
| 10 Minute Scheduled Break | Experimental | Device: Mechanical Chair MassageScheduled 10-minute break once a week for 5 weeks |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Individuals that decline to participate in the study
- Individuals currently on work restrictions
- Recent head, neck, shoulder or back surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical Chair MassageAlso: Schedule BreakHealthcare staff will be placed into either massage or break intervention | Device | 10 Minute Chair Massage, 10 Minute Scheduled Break |
Primary outcome
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
3 secondary outcomes
Change in Heart Rate of 2-arms
Time frame: 5 weeks
Change in Blood Pressure of 2-arms
Time frame: 5 weeks
Change in Self-reported level of pain on scale of 0-10
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Chair Massage in people with Stress, Psychological and Fatigue, run by Geisinger Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Professional Quality of Life Scores (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.