The Effect of Mindfulness Meditation

March 12, 2025 updated by: Buğse Yüceer, Gulhane Training and Research Hospital

The Effect of Mindfulness Meditation Practice on Compassion Fatigue, Burnout, and Psychological Well-Being of Health Professionals Working in Oncology Units: Randomized Controlled Study

Cancer is a disease that causes the most deaths worldwide and is challenging for patients and caregivers both physically and psychosocially. Physicians and nurses working in oncology clinics perform a demanding profession providing compassionate care and treatment to patients struggling with life-threatening diseases. The emotional cost of caring for patients diagnosed with cancer can lead to compassion fatigue, burnout, and decreased psychological well-being among healthcare professionals. For this reason, this research is planned as a randomized controlled study to examine the effect of Mindfulness meditation practice on compassion fatigue, burnout, and psychological well-being in physicians and nurses working in oncology units.

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.

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.
64

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 Locations

  • Turkey
      • Ankara, Turkey
        • Dr. Abdurrahman Yurtaslan Oncology Hospital

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:

  • Actively working in oncology clinics
  • At least 1 year of working experience in an oncology clinic
  • Not having a physical/mental/psychological disorder that would prevent participation in the research.
  • Oncology nurses with a high school, undergraduate, associate or graduate degree in nursing
  • Physicians and nurses who volunteer to participate in the research will be included in the research sample.

Exclusion Criteria:

  • Physicians and nurses who have been diagnosed with a psychological disease in the last two years and are continuing their medical treatment • Physicians and nurses who did not agree to participate in the research

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: 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: Mindfulness Meditation Group
During the first meeting, before the planned training, data will be collected face to face using the personal information form, Compassion Fatigue Brief Scale, Maslach Burnout Scale, Psychological Well-Being Scale. Physicians and nurses in the intervention group were given group counseling sessions by the researcher, in groups of 10-15 people, for 20 minutes once a week for 8 weeks. An online meditation practice will be provided for a long time. At the end of the mindfulness meditation application (in the 8th week) and four weeks after the end of the application (in the 12th week) for follow-up purposes, data will be collected through an online survey for physicians and nurses using Compassion Fatigue Brief Scale, Maslach Burnout Scale, Psychological Well-Being Scale.
Behavioral: Mindfulness Meditation
Mindfulness Meditation application will be implemented online by the researcher in 20-minute group sessions once a week for 8 weeks. Participants will be asked to provide a quiet, ventilated, dimly lit environment for the practice. The researcher will start the application when the participants take their places as they feel comfortable. In the first stage, the researcher will teach physicians and nurses to take deep diaphragmatic breaths through the nose and out through the mouth.
No Intervention: Control Group
During the first meeting, data will be collected face to face using the personal information form, MY-KÖ, MTÖ and PİÖÖ. In the 8th and 12th weeks of the research, the data will be re-administered to the physicians and nurses in the control group via an online survey using Compassion Fatigue Brief Scale, Maslach Burnout Scale, Psychological Well-Being Scale. After the implementation process of the research is completed, mindfulness meditation application will be applied online once to the physicians and nurses in 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
compassion fatigue
Time Frame: up to 8 weeks
At the end of the mindfulness meditation practice in oncology physicians and nurses the Compassion Fatigue Brief Scale will be used to measure the changes in compassion fatigue. As the scores obtained from the compassion fatigue brief scale increase, the perceived level of compassion fatigue in individuals increases. The lowest score from the scale is 13 and the highest score is 130.
up to 8 weeks
burnout
Time Frame: up to 8 weeks
At the end of the mindfulness meditation practice in oncology physicians and nurses the Maslach Burnout Scale will be used to measure the changes in the level of burnout. Increasing Maslach Burnout Scale "Depersonalization" and "Emotional exhaustion" subscale scores indicate that burnout increases, while increasing the "personal success" subscale score indicates that burnout decreases.
up to 8 weeks
psychological well-being
Time Frame: up to 8 weeks
At the end of the mindfulness meditation practice in oncology physicians and nurses and the Psychological Well-Being Scale will be used to evaluate the changes in the level of psychological well-being. A high score on the psychological well-being scale indicates that the person is at a positive level psychologically. The highest score from the scale is 56, while the minimum score is 8.
up to 8 weeks

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
compassion fatigue
Time Frame: up to 12 weeks
Four weeks after the end of the mindfulness meditation practice in oncology physicians and nurses the Compassion Fatigue Brief Scale will be used to measure the changes in compassion fatigue. As the scores obtained from the compassion fatigue brief scale increase, the perceived level of compassion fatigue in individuals increases. The lowest score from the scale is 13 and the highest score is 130.
up to 12 weeks
burnout
Time Frame: up to 12 weeks
Four weeks after the end of the mindfulness meditation practice in oncology physicians and nurses the Maslach Burnout Scale will be used to measure the changes in the level of burnout. Increasing Maslach Burnout Scale "Depersonalization" and "Emotional exhaustion" subscale scores indicate that burnout increases, while increasing the "personal success" subscale score indicates that burnout decreases.
up to 12 weeks
psychological well-being
Time Frame: up to 12 weeks
Four weeks after the end of the mindfulness meditation practice in oncology physicians and nurses and the Psychological Well-Being Scale will be used to evaluate the changes in the level of psychological well-being. A high score on the psychological well-being scale indicates that the person is at a positive level psychologically. The highest score from the scale is 56, while the minimum score is 8.
up to 12 weeks

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.
Gulhane Training and Research Hospital

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.
May 1, 2025

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 1, 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.
December 1, 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).
January 9, 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.
February 21, 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.
February 28, 2024

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.
March 25, 2025

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.
March 12, 2025

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.
March 1, 2025

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.
  • ---Oncology-Nursing-2024---

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

product manufactured in and exported from the U.S.

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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