The Effect of Conscious Awareness Development Psychoeducation Program Prepared for Caregivers

November 11, 2024 updated by: Nilüfer KIRANŞAL, Kafkas University

The Effect of Conscious Awareness Development Psychoeducation Program Prepared for Caregivers on Conscious Awareness, Job Stress and Compassion Fatigue.

This study aimed to increase the conscious awareness of caregivers and reduce work stress and compassion fatigue.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet 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

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.

Detailed Description

This study was planned in an experimental design with pre-test post-test follow-up measurements, experimental and control groups. The universe of the study consisted of care personnel working in institutions affiliated to the Provincial Directorate of Family, Labor and Social Services located in a city center in the east of Turkey. The sample calculation was made using the G-Power program (Experiment 14, Control 14). Since there may be omissions, the experimental group was determined as 20 participants and the control group as 20 participants. In this study, a nine-session training program will be applied to the experimental group. No application will be made to the control group. The conscious awareness development psychoeducation program will be applied once a week and for 90 minutes. Each session will be conducted in line with certain objectives. The sessions will be conducted by the investigator. Ethics committee approval was obtained before starting the study. Institutional permissions and written informed consent will be obtained for the participants. Informed consent will include information about the research and information that will ensure confidentiality.

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.
40

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

Study Locations

  • Turkey
    • Merkez
      • Kars, Merkez, Turkey, 36100
        • Faculty of Health Sciences Kafkas University
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being over 18 years of age,
  • Being actively working as a care worker in relevant institutions.

Exclusion Criteria:

  • Having received similar training before
  • Having been diagnosed with a mental illness
  • Wanting to leave the study at any stage.
  • Not having attended more than two sessions.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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: Experimental Group
The Conscious Awareness Development Psychoeducation Program will be applied to the experimental group. Conscious awareness and self-compassion techniques will be used in the psychoeducation program sessions. Homework will be given to the participants in each session. The psychoeducation program is prepared based on conscious awareness.
Other: Conscious Awareness Development Psychoeducation Program
The Conscious Awareness Development Psychoeducation Program consists of nine sessions. The sessions will be applied once a week and last 90 minutes. The psychoeducation program is prepared based on conscious awareness. Conscious awareness and self-compassion techniques will be used in the sessions. Homework will be given to the participants in each session.
No Intervention: Control Group
No application will be made to the Control Group.

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
The Mindful Attention Awareness Scale-MAAS
Time Frame: Pre-test -Post-test (9 weeks) Follow-up ( 3 month after)
Originally named The Mindful Attention Awareness Scale-MAAS, it measures the attention and present time awareness of an individual in their daily lives. It consists of 15 items and a single sub-dimension. The scale is in the form of a 6-point Likert and is evaluated as a single total score. Individuals who score high on the scale show that their conscious awareness levels are high (Brown and Rayn 2003, Özyeşil et al. 2011)
Pre-test -Post-test (9 weeks) Follow-up ( 3 month after)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
General Work Stress Scale
Time Frame: Pre-test -Post-test (9 weeks) Follow-up ( 3 month after)
The General Job Stress Scale evaluates the level of stress that an individual experiences or perceives in relation to work in general. The scale, which consists of 9 items and a single dimension, is in the form of a 5-point Likert. High scores on the scale indicate high job stress, and low scores indicate low job stress (Teleş 2021).
Pre-test -Post-test (9 weeks) Follow-up ( 3 month after)
Compassion Fatigue Scale- Short Scale Form
Time Frame: Pre-test -Post-test (9 weeks) Follow-up ( 3 month after)
The scale consists of 13 items and two sub-dimensions: secondary trauma and occupational burnout. The lowest score possible from the 10-point Likert-type scale is 13 and the highest is 130. As the scores increase, the level of compassion fatigue experienced by individuals also increases (Dinç and Ekinci, 2019).
Pre-test -Post-test (9 weeks) Follow-up ( 3 month after)

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.
Kafkas University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nilüfer KIRANŞAL, Lecturer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Estimated)

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.
December 15, 2024

Primary Completion (Estimated)

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.
November 15, 2025

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.
November 15, 2025

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).
November 4, 2024

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.
November 4, 2024

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.
November 5, 2024

Study Record Updates

Last Update Posted (Estimated)

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.
November 13, 2024

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.
November 11, 2024

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.
November 1, 2024

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.
  • KAÜ-SBF-NK 01

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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