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AzTrials

MindfulnessNCT06433544

Online Mindfulness Therapy for Pandemic Fatigue and Resilience in COVID-19 Nurses

A study testing 6-week online mindfulness course in people with Mindfulness and Nurses in COVID-19, run by Chimei Medical Center at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates online mindfulness therapy's impact on pandemic fatigue and resilience in COVID-19 quarantine ward nurses. Sixty nurses were divided into experimental and control groups, with the experimental group receiving a 6-week online mindfulness course. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Mindfulness, Nurses in COVID-19, Pandemic Fatigue
What is being tested?
6-week online mindfulness course
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTaiwan
Study dates
1 Oct 2022to 31 May 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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Over 20 years old.
  • Nurses of COVID-19 dedicated wards and dedicated intensive care units.

Who cannot join

  • Difficulty in attending
  • less than 80% of the total number of online mindfulness therapy sessions

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Chi Mei Medical Center

    Tainan, 其他（非美國）, 71004

Other trials in Taiwan

About this study

Official title: Evaluating the Effects of Online Mindfulness Therapy on Pandemic Fatigue and Resilience Among Nurses in COVID-19 Quarantine Wards

This study evaluates online mindfulness therapy's impact on pandemic fatigue and resilience in COVID-19 quarantine ward nurses. Sixty nurses were divided into experimental and control groups, with the experimental group receiving a 6-week online mindfulness course.

Read the detailed description

This study evaluates the effectiveness of online mindfulness therapy on reducing pandemic fatigue and enhancing resilience among nurses in COVID-19 quarantine wards. Using a repeated-measures quasi-experimental design, 60 nurses were divided into experimental and control groups. The experimental group participated in a 6-week online mindfulness course. Outcomes were measured using pandemic fatigue and resilience questionnaires at the pre-test , three weeks and after six weeks.

Being tested
6-week online mindfulness course
Keywords
Online mindfulness, COVID-19 quarantine ward nurses, Pandemic fatigue, Resilience

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 6-week online mindfulness courseOther

    The experimental group received a 6-week online mindfulness course, once a week for 90 minutes each session.

Study groups in NCT06433544
Study groupRoleWhat they receive
Experimental group will undergo a 6-week online mindfulness courseExperimentalThe experimental group received a 6-week online mindfulness course, once a week for 90 minutes each session. Participants completed questionnaires before the course, at week 3, and at week 6.
Receives: Other: 6-week online mindfulness course
Control groupNo interventionGeneral routine care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pandemic Fatigue

    Use Lockdown/Pandemic Fatigue Scale (LFS) measure pandemic fatigue. The scale with a total of 10 items measures pandemic fatigue. The range of total scores of the scale is 10-50. It shows that pandemic fatigue increases as total points of the scale increase.

    Measured: 6 weeks

Secondary outcomes (1)

  1. Resilience

    Use Connor-Davidson Resilience Scale (CD-RISC) measure individual resilience. The scale with a total of 25 items measures resilience. The range of total scores of the scale is 0-100. It shows that resilience increases as total points of the scale increase.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2024
  2. Study start1 Oct 2022
  3. Primary completion31 May 2023
  4. Study completion31 May 2023

Resources

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
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06433544
Sponsor's protocol ID
11112-001
Status last verified
May 2024
First submitted
23 May 2024
Last updated
29 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Afshari D, Nourollahi-Darabad M, Chinisaz N. Demographic predictors of resilience among nurses during the COVID-19 pandemic. Work. 2021;68(2):297-303. doi: 10.3233/WOR-203376.

    PubMed 33492260

  • Amutio A, Martinez-Taboada C, Delgado LC, Hermosilla D, Mozaz MJ. Acceptability and Effectiveness of a Long-Term Educational Intervention to Reduce Physicians' Stress-Related Conditions. J Contin Educ Health Prof. 2015 Fall;35(4):255-60. doi: 10.1097/CEH.0000000000000002.

    PubMed 26953856

  • Asuero AM, Queralto JM, Pujol-Ribera E, Berenguera A, Rodriguez-Blanco T, Epstein RM. Effectiveness of a mindfulness education program in primary health care professionals: a pragmatic controlled trial. J Contin Educ Health Prof. 2014 Winter;34(1):4-12. doi: 10.1002/chp.21211.

    PubMed 24648359

  • Barnett P, Barnett M, Borgueta E, Moreno JV, Watson J. COVID-19: An Organizational-theory-guided Holistic Self-caring and Resilience Project. J Holist Nurs. 2021 Dec;39(4):325-335. doi: 10.1177/08980101211007007. Epub 2021 Apr 16.

    PubMed 33861185

  • Barry KM, Woods M, Martin A, Stirling C, Warnecke E. A randomized controlled trial of the effects of mindfulness practice on doctoral candidate psychological status. J Am Coll Health. 2019 May-Jun;67(4):299-307. doi: 10.1080/07448481.2018.1515760. Epub 2018 Nov 2.

    PubMed 30388950

  • Baskin RG, Bartlett R. Healthcare worker resilience during the COVID-19 pandemic: An integrative review. J Nurs Manag. 2021 Nov;29(8):2329-2342. doi: 10.1111/jonm.13395. Epub 2021 Jul 9.

    PubMed 34182609

  • Bazarko D, Cate RA, Azocar F, Kreitzer MJ. The Impact of an Innovative Mindfulness-Based Stress Reduction Program on the Health and Well-Being of Nurses Employed in a Corporate Setting. J Workplace Behav Health. 2013 Apr;28(2):107-133. doi: 10.1080/15555240.2013.779518.

    PubMed 23667348

  • Buleon C, Minehart RD, Fischer MO. Protecting healthcare providers from COVID-19 through a large simulation training programme. Br J Anaesth. 2020 Nov;125(5):e418-e420. doi: 10.1016/j.bja.2020.07.044. Epub 2020 Aug 5. No abstract available.

    PubMed 32828493

  • Cai Z, Cui Q, Liu Z, Li J, Gong X, Liu J, Wan Z, Yuan X, Li X, Chen C, Wang G. Nurses endured high risks of psychological problems under the epidemic of COVID-19 in a longitudinal study in Wuhan China. J Psychiatr Res. 2020 Dec;131:132-137. doi: 10.1016/j.jpsychires.2020.09.007. Epub 2020 Sep 14.

    PubMed 32971356

  • Catania G, Zanini M, Hayter M, Timmins F, Dasso N, Ottonello G, Aleo G, Sasso L, Bagnasco A. Lessons from Italian front-line nurses' experiences during the COVID-19 pandemic: A qualitative descriptive study. J Nurs Manag. 2021 Apr;29(3):404-411. doi: 10.1111/jonm.13194. Epub 2020 Nov 15.

    PubMed 33107657

  • Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.

    PubMed 12964174

  • Creswell JD, Lindsay EK, Villalba DK, Chin B. Mindfulness Training and Physical Health: Mechanisms and Outcomes. Psychosom Med. 2019 Apr;81(3):224-232. doi: 10.1097/PSY.0000000000000675.

    PubMed 30806634

  • Croghan IT, Chesak SS, Adusumalli J, Fischer KM, Beck EW, Patel SR, Ghosh K, Schroeder DR, Bhagra A. Stress, Resilience, and Coping of Healthcare Workers during the COVID-19 Pandemic. J Prim Care Community Health. 2021 Jan-Dec;12:21501327211008448. doi: 10.1177/21501327211008448.

    PubMed 33834900

  • Cuadrado E, Maldonado MA, Tabernero C, Arenas A, Castillo-Mayen R, Luque B. Construction and Validation of a Brief Pandemic Fatigue Scale in the Context of the Coronavirus-19 Public Health Crisis. Int J Public Health. 2021 Aug 30;66:1604260. doi: 10.3389/ijph.2021.1604260. eCollection 2021.

    PubMed 34566554

  • de Vibe M, Solhaug I, Tyssen R, Friborg O, Rosenvinge JH, Sorlie T, Bjorndal A. Mindfulness training for stress management: a randomised controlled study of medical and psychology students. BMC Med Educ. 2013 Aug 13;13:107. doi: 10.1186/1472-6920-13-107.

    PubMed 23941053

Questions about this trial

What is this clinical trial studying?

A study testing 6-week online mindfulness course in people with Mindfulness and Nurses in COVID-19, run by Chimei Medical Center at 1 site in Taiwan.

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 2 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 29 May 2024. 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 Taiwan. 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?

Pandemic Fatigue (time frame: 6 weeks). 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 NCT06433544, which also lists 87 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 29 May 2024.

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