COVID-19 Acute Respiratory Distress SyndromeNCT05178199
The Effectiveness of RPSG Intervention for Nurses During the COVID-19
A study testing RPSG and AVMBM in people with COVID-19 Acute Respiratory Distress Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The cases of COVID-19 are continuing to be confirmed around the world. In the clinical settings, the nurses in evacuation acute wards are main responsibility to undertake the care of emergency patient follow-up and suspected or confirmed COVID-19 cases. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Acute Respiratory Distress Syndrome
- What is being tested?
- RPSG and AVMBM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2022to Nov 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The nurses have to above 20 years old.
- The nurses who work in evacuation acute wards.
Who cannot join
- The nurses who have any mental illness.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei, Taipei
Wang Hsuan Wen, 0970772465, edinawang0731@gmail.com
About this study
Official title: The Effectiveness of "Remote Psychological Support Group" Intervention for Nurses During the COVID-19 Outbreak
The cases of COVID-19 are continuing to be confirmed around the world. In the clinical settings, the nurses in evacuation acute wards are main responsibility to undertake the care of emergency patient follow-up and suspected or confirmed COVID-19 cases. Those nurses have to face the high psychological pressure, unknown panic, fear and so on. Thus, the study plans to invite nurses who are working in evacuation acute wards to participate the project called "Remote Psychological Support Group (RPSG)". The study supposes "RPSG" could improve nurses' self-efficacy, fear of COVID-19, psychological distress, and quality of life.
Read the detailed description
The cases of COVID-19 are continuing to be confirmed around the world. In the clinical settings, the nurses in evacuation acute wards are main responsibility to undertake the care of emergency patient follow-up and suspected or confirmed COVID-19 cases. Those nurses have to face the high psychological pressure, unknown panic, fear and so on. Thus, the study plans to invite nurses who are working in evacuation acute wards to participate the project called "Remote Psychological Support Group (RPSG)". The results of this study will establish the effectiveness of RPSG intervention for nurses on self-efficacy, fear of COVID-19, psychological distress, and quality of life and identify the feasibility of the RPSG. The results are also critical to improving the quality of care for nurses during the COVID-19 outbreak and the RPSG model will establish an important basis for support group in the event of other Severe Pneumonia with Novel Pathogens in the future.
- Being tested
- RPSG, AVMBM
- Keywords
- psychological support group, nurse, COVID-19, quality of life
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPSGBehavioural
The RPSG program include sharing successful experience, progressive muscle relaxation (PMR), and mindfulness-based stress reduction (MBSR). The duration is at last 8 weeks and includes 1 hour per week of RPSG activities.
AVMBMBehavioural
The duration is also at last 8 weeks and includes encouraging to use "5 minutes Audio and Video Mindfulness of Breathing Meditation (AVMBM)" per week.
| Study group | Role | What they receive |
|---|---|---|
| Remote Psychological Support Group | Experimental | The study will invite nurses through QR code on line, and assess their background, self-efficacy, fear of COVID-19, psychological distress, and quality of life by questionnaires first. Then four evacuation acute wards (A, B, C, and D) will be randomly allocated, and the two wards will be drawn out as experimental group ward. Each group will be followed for 2 months and their outcomes will be assessed at 3 time points: baseline (pre-RPSG) (T0), and 4 (T1), 8 (T2) weeks after-RPSG, T0-T2, respectively. Receives: Behavioral: RPSG; Behavioral: AVMBM |
| Mindfulness through audio and video | Active comparator | The study will invite nurses through QR code on line, and assess their background, self-efficacy, fear of COVID-19, psychological distress, and quality of life by questionnaires first. Then four evacuation acute wards (A, B, C, and D) will be randomly allocated, and the two wards will be drawn out as experimental group ward. Each group will be followed for 2 months and their outcomes will be assessed at 3 time points: baseline (pre-RPSG) (T0), and 4 (T1), 8 (T2) weeks after-RPSG, T0-T2, respectively. Receives: Behavioral: RPSG; Behavioral: AVMBM |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare self-efficacy of nurses before and after RPSG
The study uses structured questionnaires "General Self-Efficacy Scale (GSES)" to evaluate the effectiveness of RPSG. This scale is a self-report measure of self-efficacy, and it includes ten questions, each question score from 1 to 4. The total score is calculated by finding the sum of the all items, and ranges between 10 and 40, with a higher score indicating more self-efficacy.
Measured: 8 weeks
compare fear of COVID-19 for nurses before and after RPSG
The study uses structured questionnaires "the Fear of COVID-19 Scale" to evaluate the effectiveness of RPSG. The Fear of COVID-19 Scale is a seven-item scale with using a five-item Likert-type scale. A total score is calculated by adding up each item score (ranging from 7 to 35). The higher the score, the greater the fear of cororonavirus-19.
Measured: 8 weeks
compare psychological distress for nurses before and after RPSG
The study uses structured questionnaires "distress thermometer (DT) " to evaluate the effectiveness of RPSG. The distress thermometer (DT) is a rating scale used to measure distress: 0 (no distress) to 10 (extreme distress).
Measured: 8 weeks
compare quality of life for nurses before and after RPSG
The study uses structured questionnaires "WHOQOL-BREF Taiwan version" to evaluate the effectiveness of RPSG. The WHOQOL-BREF Taiwan version contains 28 items classified into the same four domains as the standard WHOQOL-BREF, and using a five-item Likert-type scale. A total score of each domain ranging from 4 to 20, with a higher score indicating better quality of life.
Measured: 8 weeks
Secondary outcomes (1)
satisfaction for RPSG
Finally, the study uses Numerical Rating Scale (VRS) to evaluate satisfaction about RPSG for nurses. The scores from zero to ten, the higher scores represent more satisfied.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study startJan 2022 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wang Hsuan Wen, Principal investigator, NTUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178199
- Sponsor's protocol ID
- 202107077RINC
- Status last verified
- Nov 2021
- First submitted
- 15 Nov 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of "Remote Psychological Support Group" Intervention for Nurses During the COVID-19 Outbreak
- ClinicalTrials.gov ID
- NCT05178199
- Acronym / sponsor ID
- 202107077RINC
- Keywords
- psychological support group, nurse, COVID-19, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 5 Jan 2022 (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 cases of COVID-19 are continuing to be confirmed around the world. In the clinical settings, the nurses in evacuation acute wards are main responsibility to undertake the care of emergency patient follow-up and suspected or confirmed COVID-19 cases. Those nurses have to face the high psychological pressure, unknown panic, fear and so on. Thus, the study plans to invite nurses who are working in evacuation acute wards to participate the project called "Remote Psychological Support Group (RPSG)". The study supposes "RPSG" could improve nurses' self-efficacy, fear of COVID-19, psychological distress, and quality of life.
Detailed description
The cases of COVID-19 are continuing to be confirmed around the world. In the clinical settings, the nurses in evacuation acute wards are main responsibility to undertake the care of emergency patient follow-up and suspected or confirmed COVID-19 cases. Those nurses have to face the high psychological pressure, unknown panic, fear and so on. Thus, the study plans to invite nurses who are working in evacuation acute wards to participate the project called "Remote Psychological Support Group (RPSG)". The results of this study will establish the effectiveness of RPSG intervention for nurses on self-efficacy, fear of COVID-19, psychological distress, and quality of life and identify the feasibility of the RPSG. The results are also critical to improving the quality of care for nurses during the COVID-19 outbreak and the RPSG model will establish an important basis for support group in the event of other Severe Pneumonia with Novel Pathogens in the future.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote Psychological Support Group | Experimental | Behavioral: RPSG, Behavioral: AVMBMThe study will invite nurses through QR code on line, and assess their background, self-efficacy, fear of COVID-19, psychological distress, and quality of life by questionnaires first. Then four evacuation acute wards (A, B, C, and D) will be randomly allocated, and the two wards will be drawn out as experimental group ward. Each group will be followed for 2 months and their outcomes will be assessed at 3 time points: baseline (pre-RPSG) (T0), and 4 (T1), 8 (T2) weeks after-RPSG, T0-T2, respectively. |
| Mindfulness through audio and video | Active comparator | Behavioral: RPSG, Behavioral: AVMBMThe study will invite nurses through QR code on line, and assess their background, self-efficacy, fear of COVID-19, psychological distress, and quality of life by questionnaires first. Then four evacuation acute wards (A, B, C, and D) will be randomly allocated, and the two wards will be drawn out as experimental group ward. Each group will be followed for 2 months and their outcomes will be assessed at 3 time points: baseline (pre-RPSG) (T0), and 4 (T1), 8 (T2) weeks after-RPSG, T0-T2, respectively. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The nurses have to above 20 years old.
- The nurses who work in evacuation acute wards.
Key exclusion criteria (1 listed)
- The nurses who have any mental illness.
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 |
|---|---|---|
| RPSGThe RPSG program include sharing successful experience, progressive muscle relaxation (PMR), and mindfulness-based stress reduction (MBSR). The duration is at last 8 weeks and includes 1 hour per week of RPSG activities. | Behavioural | Mindfulness through audio and video, Remote Psychological Support Group |
| AVMBMThe duration is also at last 8 weeks and includes encouraging to use "5 minutes Audio and Video Mindfulness of Breathing Meditation (AVMBM)" per week. | Behavioural | Mindfulness through audio and video, Remote Psychological Support Group |
Primary outcome
compare self-efficacy of nurses before and after RPSG
Time frame: 8 weeks
The study uses structured questionnaires "General Self-Efficacy Scale (GSES)" to evaluate the effectiveness of RPSG. This scale is a self-report measure of self-efficacy, and it includes ten questions, each question score from 1 to 4. The total score is calculated by finding the sum of the all items, and ranges between 10 and 40, with a higher score indicating more self-efficacy.
compare fear of COVID-19 for nurses before and after RPSG
Time frame: 8 weeks
The study uses structured questionnaires "the Fear of COVID-19 Scale" to evaluate the effectiveness of RPSG. The Fear of COVID-19 Scale is a seven-item scale with using a five-item Likert-type scale. A total score is calculated by adding up each item score (ranging from 7 to 35). The higher the score, the greater the fear of cororonavirus-19.
compare psychological distress for nurses before and after RPSG
Time frame: 8 weeks
The study uses structured questionnaires "distress thermometer (DT) " to evaluate the effectiveness of RPSG. The distress thermometer (DT) is a rating scale used to measure distress: 0 (no distress) to 10 (extreme distress).
compare quality of life for nurses before and after RPSG
Time frame: 8 weeks
The study uses structured questionnaires "WHOQOL-BREF Taiwan version" to evaluate the effectiveness of RPSG. The WHOQOL-BREF Taiwan version contains 28 items classified into the same four domains as the standard WHOQOL-BREF, and using a five-item Likert-type scale. A total score of each domain ranging from 4 to 20, with a higher score indicating better quality of life.
1 secondary outcome
satisfaction for RPSG
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
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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.
Wang Hsuan Wen principal investigator
NTUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RPSG and AVMBM in people with COVID-19 Acute Respiratory Distress Syndrome, run by National Taiwan University Hospital 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 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: status not confirmed, as of the sponsor's last update on 13 Jan 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kang chia-wen (+886975651593, 021713@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare self-efficacy of nurses before and after RPSG (time frame: 8 weeks). The study lists 4 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 13 Jan 2022.