Decreasing On-Shift Stress With a Crisis Intervention CartPhase 3NCT05944120
Decreasing On-Shift Stress With a Crisis Intervention Cart
A Phase 3 study testing Aromatherapy patches in people with Decreasing On-Shift Stress With a Crisis Intervention Cart, run by Methodist Health System at 1 site in United States.
Trial summary
This Intervention study anticipates that 100 nurses, patient care technicians and unit secretaries in the acute care setting at four Methodist Health System facilities will provide surveys to participants who had interventions Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Decreasing On-Shift Stress With a Crisis Intervention Cart
- What is being tested?
- Aromatherapy patches
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 443 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2023to 30 Jun 2025
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Part of MHS (i.e., MCMC, MMMC, MRMC, MDMC, MLMC, MSMC)
- The hospital has at least one Crisis Intervention Cart study clinical site investigator on-staff
- Hold license as a Registered Nurse OR
- Hold position as a patient care technician or unit secretary
- Must be able to read English
- Provide direct patient care or hold a unit-based leadership position (i.e., Nursing Clinical Coordinator, Nurse Manager, Clinical Team Lead)
- Full-time, part-time, or PRN employee
Who cannot join
- Hospitals and clinical units will be excluded if they are outside MHS
- Participants will be excluded if they at Director-level or above
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
This Intervention study anticipates that 100 nurses, patient care technicians and unit secretaries in the acute care setting at four Methodist Health System facilities will provide surveys to participants who had interventions
Read the detailed description
Once the intervention has been used, the participants will complete a survey in order to determine if stress levels are decreasing. Initial data collection will be over the course of two months ( April 1, 2022 through June 1, 2022) and participation will vary based upon staffing and the set criteria for Crisis Intervention Cart deployment.
- Being tested
- Aromatherapy patches
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aromatherapy patchesCombination product
Also called Crisis Intervention Cart deployment.
This study anticipates that Staff-reported stress levels will decrease when nurses use strategies from the Crisis Intervention Cart while at work.
| Study group | Role | What they receive |
|---|---|---|
| Crisis Intervention Cart | Experimental | To determine if a Crisis Intervention Cart filled with evidence-based stress-reducing interventions does reduce stress experienced during a shift. Receives: Combination Product: Aromatherapy patches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crisis Intervention Cart
The Effect of Crisis Intervention Cart filled with evidence-based stress-reducing interventions on reducing stress experienced during a shift using surveys. A 10-point Likert scale will be used with 1 being the lowest and 10 being the highest on the scale with 10 having highest level of self-perceived stress.
Measured: Period of 2 months
Secondary outcomes (1)
Type of intervention/strategy used
The Effect of Crisis Intervention Cart filled with evidence-based stress-reducing interventions on reducing stress experienced during a shift using surveys. A 10-point Likert scale will be used with 1 being the lowest and 10 being the highest on the scale with 10 having the highest level of self-perceived stress.
Measured: Period of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start6 Mar 2023
- Primary completion31 Jan 2024
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Decreasing On-Shift Stress With a Crisis Intervention CartStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- As noted in the background, resiliency-building activities appear to have a positive relationship with managing stress in the workplace. Additionally, offering a variety of strategies is anticipated to increase the sample size and encourage continued use of the strategies over time.
- Masking
- None (open label)
- Enrolment
- 443 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheyenne Ruby, DNP, Principal investigator, Methodist Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944120
- Sponsor's protocol ID
- 006.NUR.2022.A
- Status last verified
- Jul 2025
- First submitted
- 6 Jul 2023
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Publications
Badu E, O'Brien AP, Mitchell R, Rubin M, James C, McNeil K, Nguyen K, Giles M. Workplace stress and resilience in the Australian nursing workforce: A comprehensive integrative review. Int J Ment Health Nurs. 2020 Feb;29(1):5-34. doi: 10.1111/inm.12662.
PubMed 31917519Labrague LJ, de Los Santos JAA. Resilience as a mediator between compassion fatigue, nurses' work outcomes, and quality of care during the COVID-19 pandemic. Appl Nurs Res. 2021 Oct;61:151476. doi: 10.1016/j.apnr.2021.151476. Epub 2021 Jul 7.
PubMed 34544570Mintz-Binder R, Andersen S, Sweatt L, Song H. Exploring Strategies to Build Resiliency in Nurses During Work Hours. J Nurs Adm. 2021 Apr 1;51(4):185-191. doi: 10.1097/NNA.0000000000000996.
PubMed 33734177Haddad L.M., Annamaraju P., Toney-Butler T.J.: Nursing shortage.StatPearls .2020.StatPearls Publishing Available at: https://pubmed.ncbi.nlm.nih.gov/29630227/ Accessed: 03/22/2021
Manomenidis G, Panagopoulou E, Montgomery A. Resilience in nursing: The role of internal and external factors. J Nurs Manag. 2019 Jan;27(1):172-178. doi: 10.1111/jonm.12662. Epub 2018 Jul 31.
PubMed 30066352Restrepo J, Lemos M. Addressing psychosocial work-related stress interventions: A systematic review. Work. 2021;70(1):53-62. doi: 10.3233/WOR-213577.
PubMed 34511476Velana M, Rinkenauer G. Individual-Level Interventions for Decreasing Job-Related Stress and Enhancing Coping Strategies Among Nurses: A Systematic Review. Front Psychol. 2021 Jul 19;12:708696. doi: 10.3389/fpsyg.2021.708696. eCollection 2021.
PubMed 34349711
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing On-Shift Stress With a Crisis Intervention Cart
- ClinicalTrials.gov ID
- NCT05944120
- Acronym / sponsor ID
- 006.NUR.2022.A
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 443 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 13 Jul 2023 (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.
This Intervention study anticipates that 100 nurses, patient care technicians and unit secretaries in the acute care setting at four Methodist Health System facilities will provide surveys to participants who had interventions
Detailed description
Once the intervention has been used, the participants will complete a survey in order to determine if stress levels are decreasing. Initial data collection will be over the course of two months ( April 1, 2022 through June 1, 2022) and participation will vary based upon staffing and the set criteria for Crisis Intervention Cart deployment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- As noted in the background, resiliency-building activities appear to have a positive relationship with managing stress in the workplace. Additionally, offering a variety of strategies is anticipated to increase the sample size and encourage continued use of the strategies over time.
| Arm | Type | Receives |
|---|---|---|
| Crisis Intervention Cart | Experimental | Combination Product: Aromatherapy patchesTo determine if a Crisis Intervention Cart filled with evidence-based stress-reducing interventions does reduce stress experienced during a shift. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Part of MHS (i.e., MCMC, MMMC, MRMC, MDMC, MLMC, MSMC)
- The hospital has at least one Crisis Intervention Cart study clinical site investigator on-staff
- Hold license as a Registered Nurse OR
- Hold position as a patient care technician or unit secretary
- Must be able to read English
Key exclusion criteria (2 listed)
- Hospitals and clinical units will be excluded if they are outside MHS
- Participants will be excluded if they at Director-level or above
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 |
|---|---|---|
| Aromatherapy patchesAlso: Crisis Intervention Cart deployment.This study anticipates that Staff-reported stress levels will decrease when nurses use strategies from the Crisis Intervention Cart while at work. | Combination product | Crisis Intervention Cart |
Primary outcome
Crisis Intervention Cart
Time frame: Period of 2 months
The Effect of Crisis Intervention Cart filled with evidence-based stress-reducing interventions on reducing stress experienced during a shift using surveys. A 10-point Likert scale will be used with 1 being the lowest and 10 being the highest on the scale with 10 having highest level of self-perceived stress.
1 secondary outcome
Type of intervention/strategy used
Time frame: Period of 2 months
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 25 Jul 2025.
- Background: PubMed 31917519Badu E, O'Brien AP, Mitchell R, Rubin M, James C, McNeil K, Nguyen K, Giles M. Workplace stress and resilience in the Australian nursing workforce: A comprehensive integrative review. Int J Ment Health Nurs. 2020 Feb;29(1):5-34. doi: 10.1111/inm.12662.
- Background: PubMed 34544570Labrague LJ, de Los Santos JAA. Resilience as a mediator between compassion fatigue, nurses' work outcomes, and quality of care during the COVID-19 pandemic. Appl Nurs Res. 2021 Oct;61:151476. doi: 10.1016/j.apnr.2021.151476. Epub 2021 Jul 7.
- Background: PubMed 33734177Mintz-Binder R, Andersen S, Sweatt L, Song H. Exploring Strategies to Build Resiliency in Nurses During Work Hours. J Nurs Adm. 2021 Apr 1;51(4):185-191. doi: 10.1097/NNA.0000000000000996.
- BackgroundHaddad L.M., Annamaraju P., Toney-Butler T.J.: Nursing shortage.StatPearls .2020.StatPearls Publishing Available at: https://pubmed.ncbi.nlm.nih.gov/29630227/ Accessed: 03/22/2021
- Background: PubMed 30066352Manomenidis G, Panagopoulou E, Montgomery A. Resilience in nursing: The role of internal and external factors. J Nurs Manag. 2019 Jan;27(1):172-178. doi: 10.1111/jonm.12662. Epub 2018 Jul 31.
- Background: PubMed 34511476Restrepo J, Lemos M. Addressing psychosocial work-related stress interventions: A systematic review. Work. 2021;70(1):53-62. doi: 10.3233/WOR-213577.
- Background: PubMed 34349711Velana M, Rinkenauer G. Individual-Level Interventions for Decreasing Job-Related Stress and Enhancing Coping Strategies Among Nurses: A Systematic Review. Front Psychol. 2021 Jul 19;12:708696. doi: 10.3389/fpsyg.2021.708696. eCollection 2021.
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.
Cheyenne Ruby, DNP principal investigator
Methodist Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aromatherapy patches in people with Decreasing On-Shift Stress With a Crisis Intervention Cart, run by Methodist Health System 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 7 inclusion and 2 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 25 Jul 2025. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Crisis Intervention Cart (time frame: Period of 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05944120, which also lists 7 linked publications.
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 25 Jul 2025.