- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04115332
The Effects of Resilience and Mental Health of Abused Psychiatric Nurses: An Intervention With Biofeedback Training
精神科受暴護理人員復原力與心理健康之成效-以生理回饋訓練為介入措施 The Effects of Resilience and Mental Health of Abused Psychiatric Nurses: An Intervention With Biofeedback Training
Study Overview
Status
Intervention / Treatment
Detailed Description
This was a quasi-experimental study, structured questionnaires of Resilience Score, The Center for Epidemiologic Studies Depression (CES-D) and Occupational Stress Indicator-2 were used in this study before and three months after intervention. A total of 112 abused psychiatric nurses were randomly assigned to 3 groups. The biofeedback group (n=40) received the biofeedback training and the self-training group received video relaxation training by Line (n=44). The control group (n=28) did not receive any intervention.
Biofeedback training is an effective intervention to enhance abused PW nurses' resilience and lower their depressive symptoms. Video relaxation self-training is also an effective way to strengthen abused psychiatric nurses' resilience.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Kaohsiung, Taiwan
- Kaohsiung Medical University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- abused psychiatric ward (PW) nurses
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Interventional
EEG Recording The one-channel EEG sensor was recorded from Cz with linked-ear reference based on the International 10-20 system. EEG signals were recorded using BioGraph Infiniti software (Version 6.0.4, n.d.) with a band-pass between 1-30 Hz. The sample rate was 256 Hz with 60-Hz notch filters, and the electrode impedances were lower than 5 kΩ. A lead II electrocardiogram (ECG) was collected for 5 minutes at baseline using the ProComp InfinitiTM system (Thought Technology Ltd., Montreal, Canada), which was installed on a laptop. A sampling rate of 2,048/second was set in order to acquire real-time interbeat intervals. |
The aim of this study was to explore the abused PW nurses who receiving bio-feedback training as an intervention improve, and change of physiological indicators before and after intervention (3 months later), which included Respiratory Rate (RR), skin conduction (SC), heart rate variability (HRV), and resilience.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Center for Epidemiologic Studies Depression
Time Frame: 15 minutes
|
The Chinese version Center for Epidemiologic Studies Depression was developed with a Cronbach's alpha of 0_86, and it was used as the screening measure of depressive tendency in this study.
The cut-off point of the scale is of greater than or equal to 15 on the CES-D score.
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15 minutes
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The Resilience
Time Frame: 15 minutes
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The Resilience Scale was developed by Friborg et al. (2006) and the Chinese version was established by Wang and Chen with satisfactory validity and reliability.
The 29-item scale measures intrapersonal and interpersonal protective resources that may facilitate an individual's adaptability to and tolerance for stress and adverse life events.
The scale comprises five components, including personal strength, social competence, structured style, family cohesion, and social resources.
The total scores of the RS range from 29 to 203, with higher scores indicating a higher level of resilience.
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15 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EEG
Time Frame: 5 minutes
|
The one-channel EEG sensor was recorded from Cz with linked-ear reference based on the International 10-20 system.
EEG signals were recorded using BioGraph Infiniti software (Version 6.0.4,
n.d.) with a band-pass between 1-30 Hz.
|
5 minutes
|
Heart rate
Time Frame: 5 minutes
|
electrocardiogram (ECG) was collected for 5 minutes at baseline using the ProComp InfinitiTM system (Thought Technology Ltd., Montreal, Canada), which was installed on a laptop.
A sampling rate of 2,048/second was set in order to acquire real-time interbeat intervals.
|
5 minutes
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- KMUHIRB-E(II)-20170101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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