NCT05178199

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

January 13, 2022

Status Verified

November 1, 2021

Enrollment Period

7 months

First QC Date

November 15, 2021

Last Update Submit

January 11, 2022

Conditions

Keywords

psychological support groupnurseCOVID-19quality of life

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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).

    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.

    8 weeks

Secondary Outcomes (1)

  • satisfaction for RPSG

    8 weeks

Study Arms (2)

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.

Behavioral: RPSGBehavioral: 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.

Behavioral: RPSGBehavioral: AVMBM

Interventions

RPSGBEHAVIORAL

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.

Mindfulness through audio and videoRemote Psychological Support Group
AVMBMBEHAVIORAL

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.

Mindfulness through audio and videoRemote Psychological Support Group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The nurses have to above 20 years old.
  • The nurses who work in evacuation acute wards.

You may not qualify if:

  • The nurses who have any mental illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taipei, Taiwan

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Wang Hsuan Wen

    NTUH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2021

First Posted

January 5, 2022

Study Start

January 1, 2022

Primary Completion

August 1, 2022

Study Completion

November 1, 2022

Last Updated

January 13, 2022

Record last verified: 2021-11

Locations