Psychiatric Nurses, Workplace Violence, Biofeedback Training, and ResilienceNCT04115332
The Effects of Resilience and Mental Health of Abused Psychiatric Nurses: An Intervention With Biofeedback Training
A study testing bio-feedback training in people with Psychiatric Nurses, Workplace Violence, Biofeedback Training, and Resilience, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
The investigators provide biofeedback training to assist the abused PW nurses to reduce WPV-related stress and achieve better resilience and mental health. The research project will assess the participants' physiological indices prior to the intervention as well as their levels of resilience and mental status. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Psychiatric Nurses, Workplace Violence, Biofeedback Training, and Resilience
- What is being tested?
- bio-feedback training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Jul 2017to 8 Oct 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- abused psychiatric ward (PW) nurses
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
The investigators provide biofeedback training to assist the abused PW nurses to reduce WPV-related stress and achieve better resilience and mental health. The research project will assess the participants' physiological indices prior to the intervention as well as their levels of resilience and mental status.
Read the 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.
- Being tested
- bio-feedback training
- Keywords
- psychiatric nurses, workplace violence, resilience, biofeedback training, physiological indicators
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bio-feedback trainingBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | 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. Receives: Biological: bio-feedback training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Center for Epidemiologic Studies Depression
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.
Measured: 15 minutes
The Resilience
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.
Measured: 15 minutes
Secondary outcomes (2)
EEG
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.
Measured: 5 minutes
Heart rate
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start8 Jul 2017
- Primary completion8 Oct 2017
- Study completion8 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric Nurses, Workplace Violence, Biofeedback Training, and ResilienceStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04115332
- Sponsor's protocol ID
- KMUHIRB-E(II)-20170101
- Status last verified
- Apr 2017
- First submitted
- 1 Oct 2019
- Last updated
- 4 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04115332
- Acronym / sponsor ID
- KMUHIRB-E(II)-20170101
- Keywords
- psychiatric nurses, workplace violence, resilience, biofeedback training, physiological indicators
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 8 Jul 2017 (actual)
- Primary completion
- 8 Oct 2017 (actual)
- Study completion
- 8 Oct 2017 (actual)
- First posted
- 4 Oct 2019 (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 investigators provide biofeedback training to assist the abused PW nurses to reduce WPV-related stress and achieve better resilience and mental health. The research project will assess the participants' physiological indices prior to the intervention as well as their levels of resilience and mental status.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Biological: bio-feedback trainingEEG 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- abused psychiatric ward (PW) nurses
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| bio-feedback trainingThe 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. | Biological | Interventional |
Primary outcome
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.
The Resilience
Time frame: 15 minutes
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.
2 secondary outcomes
EEG
Time frame: 5 minutes
Heart rate
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bio-feedback training in people with Psychiatric Nurses, Workplace Violence, Biofeedback Training, and Resilience, run by Kaohsiung Medical University Chung-Ho Memorial 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 1 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: finished, as of the sponsor's last update on 4 Oct 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Center for Epidemiologic Studies Depression (time frame: 15 minutes). The study lists 2 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 4 Oct 2019.