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

Primary Purpose

COVID-19 Acute Respiratory Distress Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
RPSG
AVMBM
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for COVID-19 Acute Respiratory Distress Syndrome focused on measuring psychological support group, nurse, COVID-19, quality of life

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • The nurses who have any mental illness.

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Remote Psychological Support Group

Mindfulness through audio and video

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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).
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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 15, 2021
Last Updated
January 11, 2022
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05178199
Brief Title
The Effectiveness of RPSG Intervention for Nurses During the COVID-19
Official Title
The Effectiveness of "Remote Psychological Support Group" Intervention for Nurses During the COVID-19 Outbreak
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Acute Respiratory Distress Syndrome
Keywords
psychological support group, nurse, COVID-19, quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Remote Psychological Support Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Mindfulness through audio and video
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
RPSG
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
AVMBM
Intervention Description
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.
Primary Outcome Measure Information:
Title
compare self-efficacy of nurses before and after RPSG
Description
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.
Time Frame
8 weeks
Title
compare fear of COVID-19 for nurses before and after RPSG
Description
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.
Time Frame
8 weeks
Title
compare psychological distress for nurses before and after RPSG
Description
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).
Time Frame
8 weeks
Title
compare quality of life for nurses before and after RPSG
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
satisfaction for RPSG
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The nurses have to above 20 years old. The nurses who work in evacuation acute wards. Exclusion Criteria: The nurses who have any mental illness.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kang chia-wen
Phone
+886975651593
Email
021713@ntuh.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang Hsuan Wen
Organizational Affiliation
NTUH
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
Taipei
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Hsuan Wen
Phone
0970772465
Email
edinawang0731@gmail.com

12. IPD Sharing Statement

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

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