Evaluation of the Effect of Cognitive Behavioral Approach-Based Stress Coping Skills Training Program on Stress Perception, Resilience and Compassion Fatigue

September 6, 2023 updated by: Ozge AYDOGAN ASIR, Eskisehir Osmangazi University

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:

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: OZLEM ORSAL

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  • 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.

Exclusion Criteria:

  • 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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cognitive Behavioral Therapy (CBT)
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.
Behavioral: Cognitive Behavioral Therapy
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.
Active Comparator: Mobile Mental Health Support System created by the Turkish Ministry of Health
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.
Behavioral: T.R. Mobile Mental Health Support System produced by the Ministry of Health
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
5 months
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.
5 months
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.
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eskisehir Osmangazi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 12, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 12, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OZGE AYDOGAN ASIR
  • OZLEM ORSAL (Other Identifier: EskişehirOU)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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