Stress Perception, Psychological Resilience, Compassion FatigueNCT05830448
Evaluation of the Effect of Cognitive Behavioral Approach-Based Stress Coping Skills Training Program on Stress Perception, Resilience and Compassion Fatigue
A study testing Cognitive Behavioral Therapy and T.R. Mobile Mental Health Support System produced by the Ministry of Health in people with Stress Perception, Psychological Resilience, Compassion Fatigue, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
This research is an experimental study with a randomized pre-test-post-test control group to evaluate the effect of the cognitive behavioral approach-based stress coping skills training program carried out by tele-nursing on the palliative care nurses' perception of stress, resilience and compassion fatigue. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stress Perception, Psychological Resilience, Compassion Fatigue
- What is being tested?
- Cognitive Behavioral Therapy and T.R. Mobile Mental Health Support System produced by the Ministry of Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Nov 2021to 12 Oct 2023
- 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
- Working as a nurse in designated hospitals in Eskişehir,
- To have been working in palliative care services for at least one month,
- Having active internet access and being able to actively use a computer/tablet or smart phone.
- Volunteering to participate in the research.
Who cannot join
- Working in hospitals located in other provinces of Turkey,
- Working in all units in hospitals except the palliative care service,
- Having any psychiatric diagnosis other than stress,
- Being currently receiving psychological counseling,
Trial locations and contacts
1 site in 1 country.
OZLEM ORSAL contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Eskisehir Osmangazi Universty
Eskişehir
OZGE AYDOGAN ASIR, 05076239241, aydogan.ozge.92.123@gmail.com
About this study
Official title: Evaluation of the Effect of Cognitive Behavioral Approach-Based Stress Coping Skills Training Program Performed by Tele-Nursing on Stress Perception, Resilience and Compassion Fatigue in Palliative Care Nurses
This research is an experimental study with a randomized pre-test-post-test control group to evaluate the effect of the cognitive behavioral approach-based stress coping skills training program carried out by tele-nursing on the palliative care nurses' perception of stress, resilience and compassion fatigue.
The main questions it aims to answer are:
Read more
Question 1. Will the cognitive behavioral approach-based stress coping skills training program to be carried out through tele-nursing have an effect on the increase in the stress coping score of the palliative care nurses in the intervention group? Question 2. Will the cognitive behavioral approach-based stress coping skills training program to be carried out through tele-nursing have an effect on the reduction of stress perception among palliative care nurses in the intervention group? Question 3. Will the cognitive behavioral approach-based stress coping skills training program to be carried out through tele-nursing have an impact on the increase in resilience of palliative care nurses in the intervention group? Question 4. Will the cognitive behavioral approach-based stress coping skills training program to be carried out through tele-nursing have an effect on the reduction of compassion fatigue in palliative care nurses in the intervention group? The research was planned as a randomized controlled experimental design with the required ethics committee and institution permissions, a three-month announcement and initiation period, and an eight-week intervention period. Data will be collected twice at baseline and after intervention (Week 9). Personal information form, Perceived Stress Scale, Coping with Stress Scale, Connor-Davidson Resilience Scale, Quality of Life Scale for Employees will be used in the pre-test phase of data collection. Participants meeting the inclusion criteria will be assigned to the intervention and control groups by randomization. In order to support nurses in the intervention group to gain awareness of stress and anxiety and develop positive coping skills with stress, a total of 8 sessions of 40 minutes are planned, including interaction steps based on education and cognitive approach. Individuals will be given homework from the second week and they will be asked to deliver these homeworks to the researcher 2 days before the next interview, and it is planned to send reminder messages from the WastApp group created. Participants who do not deliver the assignments given in this study to the researcher on time will be excluded from the research even if they participate in online training.
No intervention will be applied to individuals assigned to the control group. Participants will be informed about the Mobile Mental Health Support System created by the Turkish Ministry of Health and will be directed to this application.
It is planned to apply Perceived Stress Scale, Coping with Stress Scale, Connor-Davidson Resilience Scale, Quality of Life Scale for Employees at the 9th week for the application of post-tests.
- Being tested
- Cognitive Behavioral Therapy, T.R. Mobile Mental Health Support System produced by the Ministry of Health
- Keywords
- palliative care nurses, Stress, Stress Perception, Ability to Cope with Stress, Psychological Resilience, Compassion Fatigue
- Medical subject headings
- Compassion Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
The trial was planned to have a three-month announcement and an eight-week intervention period. Personal information form, Perceived Stress Scale, Coping with Stress Scale, Connor-Davidson Resilience Scale, Quality of Life Scale for Employees will be used in the pre-test phase of data collection. Participants meeting the inclusion criteria will be randomly assigned to the intervention and control groups. In order to support nurses in the intervention group to gain awareness of stress and anxiety and develop positive coping skills, 8 sessions of 40 minutes were planned, including interaction steps based on education and cognitive approach. As of the second week, homework will be given to individuals and they will be asked to submit these assignments to the researcher 2 days before the next interview. Participants who do not submit the assignments given in this study to the researcher on time will be excluded from the study even if they have completed the training.
T.R. Mobile Mental Health Support System produced by the Ministry of HealthBehavioural
No intervention will be applied to the individuals assigned to the control group by the researcher. Participants will be informed about the Mobile Mental Health Support System created by the Turkish Ministry of Health and will be directed to this application.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Experimental | CBD is a model that applies learning theories to assist people when they encounter difficulties and life problems that they cannot cope with in their daily lives. It focuses on the elements that affect emotions and behaviors, that is, the thought system. CBT is a process that involves changing the automatic thoughts and evaluations that occur when people are faced with negative situations with different thoughts that can create alternatives and restructuring these thoughts. The approach essentially argues that the way events are perceived and interpreted is more important than how they happen. Systematic errors in information processing, which cause people to perceive themselves, their environment and their future negatively, cause stress and symptoms of mental disorders. There are studies showing that cognitive behavioral therapy reduces stress levels and stress symptoms. Receives: Behavioral: Cognitive Behavioral Therapy |
| Mobile Mental Health Support System created by the Turkish Ministry of Health | Active comparator | This system aims to protect and support the mental health of the health personnel of the Ministry of Health. It is a mobile application that allows video calls with a secure and official channel with voluntary adult and child-adolescent mental health and diseases specialists for himself and his children. Personnel who want to benefit from the said service will be able to access the service by downloading the Ministry of Health RUHSAD application to their mobile devices after searching for "Mental Health Support System" in the mobile application markets and following the instructions. Receives: Behavioral: T.R. Mobile Mental Health Support System produced by the Ministry of Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale
The stress perception of the nurses working in the palliative care service will be evaluated. The minimum score that can be obtained from the perceived stress scale is 0, and the maximum score is 56. A higher score on this scale means a worse result.
Measured: 5 months
Connor-Davidson Resilience Scale
The psychological resilience levels of the nurses working in the palliative care service will be evaluated. The minimum score that can be obtained from the Connor-Davidson Resilience scale is 0, and the maximum score is 100. A higher score on this scale means a better result.
Measured: 5 months
Quality of Life Scale for Employees - Compassion Fatigue Sub-Dimension
Information about compassion fatigue of nurses working in palliative care service will be given. The minimum score that can be obtained from the Employee Quality of Life Scale - Compassion Fatigue Sub-Dimension is 0, and the maximum score is 50. A higher score on this scale means a worse result.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start12 Nov 2021
- Primary completion15 Jan 2023
- Study completion12 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Perception, Psychological Resilience, Compassion FatigueStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental study with randomized pretest-posttest control group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozge AYDOGAN ASIR, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830448
- Sponsor's protocol ID
- OZGE AYDOGAN ASIR
- Other IDs
- OZLEM ORSAL
- Status last verified
- Sep 2023
- First submitted
- 31 Jan 2023
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Cognitive Behavioral Approach-Based Stress Coping Skills Training Program Performed by Tele-Nursing on Stress Perception, Resilience and Compassion Fatigue in Palliative Care Nurses
- ClinicalTrials.gov ID
- NCT05830448
- Acronym / sponsor ID
- OZGE AYDOGAN ASIR
- Keywords
- palliative care nurses, Stress, Stress Perception, Ability to Cope with Stress, Psychological Resilience, Compassion Fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 12 Nov 2021 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 12 Oct 2023 (estimated)
- First posted
- 26 Apr 2023 (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.
This research is an experimental study with a randomized pre-test-post-test control group to evaluate the effect of the cognitive behavioral approach-based stress coping skills training program carried out by tele-nursing on the palliative care nurses' perception of stress, resilience and compassion fatigue.
The main questions it aims to answer are:
Question 1. Will the cognitive behavioral approach-based stress coping skills training program to be carried out through tele-nursing have an effect on the increase in the stress coping score of the palliative care nurses in the intervention group? Question 2. Will the cognitive behavioral approach-based stress coping skills training program to be carried out through tele-nursing have an effect on the reduction of stress perception among palliative care nurses in the intervention group? Question 3. Will the cognitive behavioral approach-based stress coping skills training program to be carried out through tele-nursing have an impact on the increase in resilience of palliative care nurses in the intervention group? Question 4. Will the cognitive behavioral approach-based stress coping skills training program to be carried out through tele-nursing have an effect on the reduction of compassion fatigue in palliative care nurses in the intervention group? The research was planned as a randomized controlled experimental design with the required ethics committee and institution permissions, a three-month announcement and initiation period, and an eight-week intervention period. Data will be collected twice at baseline and after intervention (Week 9). Personal information form, Perceived Stress Scale, Coping with Stress Scale, Connor-Davidson Resilience Scale, Quality of Life Scale for Employees will be used in the pre-test phase of data collection. Participants meeting the inclusion criteria will be assigned to the intervention and control groups by randomization. In order to support nurses in the intervention group to gain awareness of stress and anxiety and develop positive coping skills with stress, a total of 8 sessions of 40 minutes are planned, including interaction steps based on education and cognitive approach. Individuals will be given homework from the second week and they will be asked to deliver these homeworks to the researcher 2 days before the next interview, and it is planned to send reminder messages from the WastApp group created. Participants who do not deliver the assignments given in this study to the researcher on time will be excluded from the research even if they participate in online training.
No intervention will be applied to individuals assigned to the control group. Participants will be informed about the Mobile Mental Health Support System created by the Turkish Ministry of Health and will be directed to this application.
It is planned to apply Perceived Stress Scale, Coping with Stress Scale, Connor-Davidson Resilience Scale, Quality of Life Scale for Employees at the 9th week for the application of post-tests.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental study with randomized pretest-posttest control group
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Experimental | Behavioral: Cognitive Behavioral TherapyCBD is a model that applies learning theories to assist people when they encounter difficulties and life problems that they cannot cope with in their daily lives. It focuses on the elements that affect emotions and behaviors, that is, the thought system. CBT is a process that involves changing the automatic thoughts and evaluations that occur when people are faced with negative situations with different thoughts that can create alternatives and restructuring these thoughts. The approach essentially argues that the way events are perceived and interpreted is more important than how they happen. Systematic errors in information processing, which cause people to perceive themselves, their environment and their future negatively, cause stress and symptoms of mental disorders. There are studies showing that cognitive behavioral therapy reduces stress levels and stress symptoms. |
| Mobile Mental Health Support System created by the Turkish Ministry of Health | Active comparator | Behavioral: T.R. Mobile Mental Health Support System produced by the Ministry of HealthThis system aims to protect and support the mental health of the health personnel of the Ministry of Health. It is a mobile application that allows video calls with a secure and official channel with voluntary adult and child-adolescent mental health and diseases specialists for himself and his children. Personnel who want to benefit from the said service will be able to access the service by downloading the Ministry of Health RUHSAD application to their mobile devices after searching for "Mental Health Support System" in the mobile application markets and following the instructions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Working as a nurse in designated hospitals in Eskişehir,
- To have been working in palliative care services for at least one month,
- Having active internet access and being able to actively use a computer/tablet or smart phone.
- Volunteering to participate in the research.
Key exclusion criteria (4 listed)
- Working in hospitals located in other provinces of Turkey,
- Working in all units in hospitals except the palliative care service,
- Having any psychiatric diagnosis other than stress,
- Being currently receiving psychological counseling,
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 |
|---|---|---|
| Cognitive Behavioral TherapyThe trial was planned to have a three-month announcement and an eight-week intervention period. Personal information form, Perceived Stress Scale, Coping with Stress Scale, Connor-Davidson Resilience Scale, Quality of Life Scale for Employees will be used in the pre-test phase of data collection. Participants meeting the inclusion criteria will be randomly assigned to the intervention and control groups. In order to support nurses in the intervention group to gain awareness of stress and anxiety and develop positive coping skills, 8 sessions of 40 minutes were planned, including interaction steps based on education and cognitive approach. As of the second week, homework will be given to individuals and they will be asked to submit these assignments to the researcher 2 days before the next interview. Participants who do not submit the assignments given in this study to the researcher on time will be excluded from the study even if they have completed the training. | Behavioural | Cognitive Behavioral Therapy (CBT) |
| T.R. Mobile Mental Health Support System produced by the Ministry of HealthNo intervention will be applied to the individuals assigned to the control group by the researcher. Participants will be informed about the Mobile Mental Health Support System created by the Turkish Ministry of Health and will be directed to this application. | Behavioural | Mobile Mental Health Support System created by the Turkish Ministry of Health |
Primary outcome
Perceived Stress Scale
Time frame: 5 months
The stress perception of the nurses working in the palliative care service will be evaluated. The minimum score that can be obtained from the perceived stress scale is 0, and the maximum score is 56. A higher score on this scale means a worse result.
Connor-Davidson Resilience Scale
Time frame: 5 months
The psychological resilience levels of the nurses working in the palliative care service will be evaluated. The minimum score that can be obtained from the Connor-Davidson Resilience scale is 0, and the maximum score is 100. A higher score on this scale means a better result.
Quality of Life Scale for Employees - Compassion Fatigue Sub-Dimension
Time frame: 5 months
Information about compassion fatigue of nurses working in palliative care service will be given. The minimum score that can be obtained from the Employee Quality of Life Scale - Compassion Fatigue Sub-Dimension is 0, and the maximum score is 50. A higher score on this scale means a worse result.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Individual participant dataSharing planned: No
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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.
OZLEM ORSAL contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy and T.R. Mobile Mental Health Support System produced by the Ministry of Health in people with Stress Perception, Psychological Resilience, Compassion Fatigue, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Sep 2023. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact OZGE AYDOGAN ASIR (05076239241, aydogan.ozge.92.123@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (time frame: 5 months). The study lists 3 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 8 Sep 2023.