COVID-19NCT06267534
Mindfulness-based Mobile Applications Program
A study testing mindfulness-based mobile applications program in people with COVID-19 and Cell Phone Use, run by Yu-Chien Huang at 1 site in Taiwan.
Trial summary
The goal of this type of study: quasi-experimental clinical trial . The purpose of this study is to explore the effects of applying mindfulness-based mobile applications program to maintaining mental health of emergency nurses during providing care to COVID-19 patients. The main question[s] it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Cell Phone Use, Nurse
- What is being tested?
- mindfulness-based mobile applications program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Sep 2022to 22 Sep 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have a license to practice nurses; have worked in the medical center for more than three months; and are emergency clinical nurses who have experience in caring for COVID-19 nucleic acid test patients.
Who cannot join
- The exclusion criteria were emergency clinical nurses who had received courses related to mindfulness training.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Mindfulness-based Mobile Applications Program on Mental Health of Emergency Nurses Caring for COVID-19 Patients
The goal of this type of study: quasi-experimental clinical trial . The purpose of this study is to explore the effects of applying mindfulness-based mobile applications program to maintaining mental health of emergency nurses during providing care to COVID-19 patients. The main question[s] it aims to answer are:
- To explore the effect of mindfulness-based mobile device-assisted program on care stress of emergency nurses caring for COVID-19 patients.
- To explore the impact of mindfulness-based mobile device-assisted programs on the psychological distress of emergency nurses caring for COVID-19 patients.
- To explore the impact of a mindfulness-based mobile device-assisted program on compassion fatigue in emergency nurses caring for COVID-19 patients.
Participants will Mindfulness-based mobile device is provided to experimental group as assistance for 2 weeks. In the contrary, no intervention measure was assigned in the control group. Scale exam was performed before and after the program in both groups at the same time.
Read the detailed description
This study was a quasi-experimental study with two groups of pretest and posttest to facilitate sampling from the emergency room of Mackay Memorial Hospital. Emergency nurses at Taipei Mackay Memorial Hospital were in the experimental group, and emergency nurses at Tamsui Mackay Memorial Hospital were in the control group. These cases are expected to be accepted. There were 54 people in the experimental group and 54 people in the control group. The experimental group received a two-week mindfulness-based mobility device-assisted program. The program is a mobile application developed by researchers and designed for use on smartphones, tablets, and other mobile devices. The program content is facilitated and guided by certified instructors from the Center for Mindfulness (CFM) at the University of Massachusetts Medical School. Five suitable sound files were provided to guide subjects in practicing mindfulness. Each audio file is approximately 10 to 15 minutes in length. The control group did not take any intervention measures. The experimental group was tested on the scale before and after the program, and the control group was also measured at the same time. Research tools include the Nursing Stress Scale, Psychological Distress Scale, and Compassion Exhaustion Scale. The SPSS 20.0 software package was used for statistical analysis and processing of the data, and covariates were used to analyze the results. The findings will help improve mental health by reducing stress, psychological distress and compassion fatigue among emergency nurse practitioners caring for COVID-19 patients.
- Conditions
- COVID-19, Cell Phone Use, Nurse, Mental Health
- Being tested
- mindfulness-based mobile applications program
- Medical subject headings
- COVID-19, Cell Phone Use, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness-based mobile applications programDevice
Every two days is the same practice sound file, which must be practiced in order, so each sound file will be locked, for example: 9/9, 9/10 listen to the first sound file practice, 9/11, 9/12 listen to the second Practice with two sound files... and so on. After two days, the sound files will be automatically unlocked, and the subjects can continue to practice. The first ten days need to be practiced in order. From the eleventh day, each sound file will be unlocked. You can choose an audio file to practice, and the page will record the time and items of the practice, and you can also use text to record your experience after the practice
| Study group | Role | What they receive |
|---|---|---|
| mindfulness-based mobile applications program | Experimental | mindfulness-based mobile applications program. There are five audio files, listen to one audio file for two days. Receives: Device: mindfulness-based mobile applications program |
| NO intervention | No intervention | The control group received no intervention, Scale exam was performed before and after the program in both groups at the same time. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The impact of mindfulness-based mobile device assistance program on the care stress of emergency nursing staff caring for COVID-19 patients
This study uses the "Nursing Stress Questionnaire under the COVID-19 Epidemic" as a measure of caregiving stress. The content includes five major aspects: worries about social isolation (10 questions), discomfort caused by protective equipment (8 questions), and infection control. Difficulties and anxiety (7 questions), burden of caring for patients (7 questions), and policy pressure (8 questions). The scoring method adopts a four-point Likert scale, ranging from no pressure (0 points) to severe pressure (3 points), a total of 40 questions, with a total score of 0-120 points. The higher the score, the greater the caregiving pressure.emergency nurses caring for COVID-19 patients
Measured: Two weeks
Effects of mindfulness-based mobile device assistance program on psychological distress among emergency nursing staff caring for COVID-19 patients
This study used the "Short Form Health Scale" to measure the degree of psychological distress among caregivers caring for COVID-19 patients. There are five questions in the questionnaire, and the scoring method adopts a five-point Likert scale, ranging from not at all (0 points) to very good (4 points), with a total score of 0-20 points. The grading method is: a total score ≤ 5 is within the normal range, indicating good physical and mental adaptation; 6-9 is considered mild emotional distress; 10-14 is considered moderate emotional distress; and a score of 15 or above is severe emotional distress.
Measured: Two weeks
Effects of a mindfulness-based mobile device-assisted program on compassion fatigue among emergency nursing staff caring for COVID-19 patients
The amount of compassion fatigue is measured using 23 questions of the Compassion Fatigue Self Test (CFST) developed by Figley (1995). Compassion fatigue is graded. Scores below 30 are classified as low risk; scores between 31 and 35 are classified as low risk. Medium risk; 36-40 is considered high risk; above 41 is considered extremely high risk
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start9 Sep 2022
- Primary completion22 Sep 2022
- Study completion22 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yu-Chien Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yu-Chien Huang, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267534
- Sponsor's protocol ID
- YCH
- Status last verified
- Feb 2024
- First submitted
- 20 Oct 2023
- Last updated
- 20 Feb 2024
- 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 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Mindfulness-based Mobile Applications Program on Mental Health of Emergency Nurses Caring for COVID-19 Patients
- ClinicalTrials.gov ID
- NCT06267534
- Acronym / sponsor ID
- YCH
- Conditions
- COVID-19, Cell Phone Use, Nurse, Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Yu-Chien HuangUniversity, hospital or other
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 22 Sep 2022 (actual)
- Study completion
- 22 Sep 2022 (actual)
- First posted
- 20 Feb 2024 (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 goal of this type of study: quasi-experimental clinical trial . The purpose of this study is to explore the effects of applying mindfulness-based mobile applications program to maintaining mental health of emergency nurses during providing care to COVID-19 patients. The main question[s] it aims to answer are:
- To explore the effect of mindfulness-based mobile device-assisted program on care stress of emergency nurses caring for COVID-19 patients.
- To explore the impact of mindfulness-based mobile device-assisted programs on the psychological distress of emergency nurses caring for COVID-19 patients.
- To explore the impact of a mindfulness-based mobile device-assisted program on compassion fatigue in emergency nurses caring for COVID-19 patients.
Participants will Mindfulness-based mobile device is provided to experimental group as assistance for 2 weeks. In the contrary, no intervention measure was assigned in the control group. Scale exam was performed before and after the program in both groups at the same time.
Detailed description
This study was a quasi-experimental study with two groups of pretest and posttest to facilitate sampling from the emergency room of Mackay Memorial Hospital. Emergency nurses at Taipei Mackay Memorial Hospital were in the experimental group, and emergency nurses at Tamsui Mackay Memorial Hospital were in the control group. These cases are expected to be accepted. There were 54 people in the experimental group and 54 people in the control group. The experimental group received a two-week mindfulness-based mobility device-assisted program. The program is a mobile application developed by researchers and designed for use on smartphones, tablets, and other mobile devices. The program content is facilitated and guided by certified instructors from the Center for Mindfulness (CFM) at the University of Massachusetts Medical School. Five suitable sound files were provided to guide subjects in practicing mindfulness. Each audio file is approximately 10 to 15 minutes in length. The control group did not take any intervention measures. The experimental group was tested on the scale before and after the program, and the control group was also measured at the same time. Research tools include the Nursing Stress Scale, Psychological Distress Scale, and Compassion Exhaustion Scale. The SPSS 20.0 software package was used for statistical analysis and processing of the data, and covariates were used to analyze the results. The findings will help improve mental health by reducing stress, psychological distress and compassion fatigue among emergency nurse practitioners caring for COVID-19 patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mindfulness-based mobile applications program | Experimental | Device: mindfulness-based mobile applications programmindfulness-based mobile applications program. There are five audio files, listen to one audio file for two days. |
| NO intervention | No intervention | –The control group received no intervention, Scale exam was performed before and after the program in both groups at the same time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Have a license to practice nurses; have worked in the medical center for more than three months; and are emergency clinical nurses who have experience in caring for COVID-19 nucleic acid test patients.
Key exclusion criteria (1 listed)
- The exclusion criteria were emergency clinical nurses who had received courses related to mindfulness training.
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 |
|---|---|---|
| mindfulness-based mobile applications programEvery two days is the same practice sound file, which must be practiced in order, so each sound file will be locked, for example: 9/9, 9/10 listen to the first sound file practice, 9/11, 9/12 listen to the second Practice with two sound files... and so on. After two days, the sound files will be automatically unlocked, and the subjects can continue to practice. The first ten days need to be practiced in order. From the eleventh day, each sound file will be unlocked. You can choose an audio file to practice, and the page will record the time and items of the practice, and you can also use text to record your experience after the practice | Device | mindfulness-based mobile applications program |
Primary outcome
The impact of mindfulness-based mobile device assistance program on the care stress of emergency nursing staff caring for COVID-19 patients
Time frame: Two weeks
This study uses the "Nursing Stress Questionnaire under the COVID-19 Epidemic" as a measure of caregiving stress. The content includes five major aspects: worries about social isolation (10 questions), discomfort caused by protective equipment (8 questions), and infection control. Difficulties and anxiety (7 questions), burden of caring for patients (7 questions), and policy pressure (8 questions). The scoring method adopts a four-point Likert scale, ranging from no pressure (0 points) to severe pressure (3 points), a total of 40 questions, with a total score of 0-120 points. The higher the score, the greater the caregiving pressure.emergency nurses caring for COVID-19 patients
Effects of mindfulness-based mobile device assistance program on psychological distress among emergency nursing staff caring for COVID-19 patients
Time frame: Two weeks
This study used the "Short Form Health Scale" to measure the degree of psychological distress among caregivers caring for COVID-19 patients. There are five questions in the questionnaire, and the scoring method adopts a five-point Likert scale, ranging from not at all (0 points) to very good (4 points), with a total score of 0-20 points. The grading method is: a total score ≤ 5 is within the normal range, indicating good physical and mental adaptation; 6-9 is considered mild emotional distress; 10-14 is considered moderate emotional distress; and a score of 15 or above is severe emotional distress.
Effects of a mindfulness-based mobile device-assisted program on compassion fatigue among emergency nursing staff caring for COVID-19 patients
Time frame: Two weeks
The amount of compassion fatigue is measured using 23 questions of the Compassion Fatigue Self Test (CFST) developed by Figley (1995). Compassion fatigue is graded. Scores below 30 are classified as low risk; scores between 31 and 35 are classified as low risk. Medium risk; 36-40 is considered high risk; above 41 is considered extremely high risk
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 20 Feb 2024.
- 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 mindfulness-based mobile applications program in people with COVID-19 and Cell Phone Use, run by Yu-Chien Huang 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 1 inclusion and 1 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 20 Feb 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?
The impact of mindfulness-based mobile device assistance program on the care stress of emergency nursing staff caring for COVID-19 patients (time frame: Two weeks). The study lists 3 primary outcomes in all. 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 20 Feb 2024.