The Effectiveness of RPSG Intervention for Nurses During the COVID-19

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05178199

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Acute Respiratory Distress Syndrome	Behavioral: RPSG Behavioral: AVMBM	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Supportive Care

Official Title:

The Effectiveness of "Remote Psychological Support Group" Intervention for Nurses During the COVID-19 Outbreak

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Remote Psychological Support Group 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: RPSG 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. Behavioral: AVMBM 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.
Active Comparator: Mindfulness through audio and video 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: RPSG 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. Behavioral: AVMBM 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.

Arm

Intervention/Treatment

Experimental: Remote Psychological Support Group

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: RPSG

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.

Behavioral: AVMBM

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.

Active Comparator: Mindfulness through audio and video

Behavioral: RPSG

Behavioral: AVMBM

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.

Outcome Measures

Primary Outcome Measures

compare self-efficacy of nurses before and after RPSG [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 [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 [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 [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.

Secondary Outcome Measures

satisfaction for RPSG [8 weeks]
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.