NCT05886959

Brief Summary

In this study, it was aimed to determine the effect of "Mindfulness-Based Compassionate Life Training" given to the relatives of patients in the palliative care clinic on burnout and care burden. According to the experimental design with pretest and posttest control groups, participants selected from the universe were assigned to the experimental and control groups in an unbiased manner. In this study, a priori power analysis was performed to determine the sample size, and Cohen's standard effect sizes were taken as reference. It was determined that the effects of "Mindfulness-Based Compassionate Life Training" on burnout and care burden in the relatives of the patients in the palliative care clinic would be compared for the independent groups, and it was determined that 80% power would be obtained at the 0.05 significance level at the 95% confidence interval. Considering the data losses and including a 30% backup sample, the research was started with a total of 68 participants. Participants included in the study were numbered from 1 to 68, and 34 experimental and 34 control groups were created at www.random.org. During the application process, 8 people from the experimental group and 6 people from the control group were separated. The research continues with 26 experimental and 28 control groups. Pre-test data were collected before the participants in the experimental group and control group were applied. Participants in the experimental group are given 8 sessions of Mindfulness-Based Compassionate Life training. The trainings are carried out face to face in the busy room of the palliative care clinic. Each session is held between 3 days and 7 days for its effectiveness and continuity. One week after the Awareness-Based Compassionate Life training (after 8 sessions are completed), the relatives of the patients hospitalized in the palliative care clinic will be filled with a face-to-face interview with the "Maslach Burnout Scale, Caregiver Burden Scale, Self-Compassion Scale Short Form" posttest. Post-test data will be taken simultaneously from the experimental and control groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 24, 2023

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2023

Completed
Last Updated

June 4, 2024

Status Verified

June 1, 2024

Enrollment Period

1 month

First QC Date

May 24, 2023

Last Update Submit

June 3, 2024

Conditions

Keywords

Caregiving burdenMindfulnessPalliative careInformal CaregiverBurnout

Outcome Measures

Primary Outcomes (1)

  • Introductory Information Form

    The form consists of 10 questions containing information about the patient and caregiver in the palliative clinic created by the researcher within the scope of the literature. The created form includes questions covering the caregiver's age, gender, place of residence, educational status, social security, marital status, profession, and the process in which she cares for her patient.

    up to 1 day

Secondary Outcomes (1)

  • Maslach Burnout Scale

    up to 1 day

Other Outcomes (2)

  • Caregiver Burden Scale

    up to 1 day

  • Short Form of Self-Compassion Scale (SSS-C)

    up to 1 day

Study Arms (8)

Session 1: How We Evolved - Threat, Impulse, and Soothing Systems

EXPERIMENTAL

* A "breath break with kindness" is practiced. * Encourage them to think about how threat, impulse and sedative systems have developed in their own lives. * A "safe place" application is made. * "Courtesy meditation" is done.

Other: Session 1: How We Evolved - Threat, Impulse, and Soothing Systems

Session 2: Threat and Self-Compassion

EXPERIMENTAL

* A "breath break with kindness" is practiced. * "Building a compassionate relationship with resilience" and "kindness meditation: a benevolent" practices are made. * "A hand on your heart" and "a compassionate comrade" practices are made.

Other: Session 2: Threat and Self-Compassion

Session 3: Unraveling the Knots of Desire and Patterns Agenda

EXPERIMENTAL

* Talk about homework. * A "breath break with kindness" is practiced. * "Establishing a compassionate relationship with desire", "guided meditation to discover the inner pattern", "courtesy meditation: a good friend" practices are made.

Other: Session 3: Unraveling the Knots of Desire and Patterns

Session 4: Internalizing compassion

EXPERIMENTAL

* "Pretend-to-pretend" practice is made for participants to observe themselves. * In addition to the previous practices, the practice of "internalizing compassion" is made in order to increase their expanded mindfulness. * Courtesy meditation: a neutral person", "kindness towards your body", which is based on mindfulness practices and increases body awareness and mindful movement, is carried out. During the day, they will be informed that they should do the "walking with kindness" practice on their own

Other: Session 4: Internalizing compassion

Session 5: Me and others - Expanding the circle

EXPERIMENTAL

* A "compassionate letter" application is made by asking participants to think about a situation they encountered recently or some time ago and is still causing distress. It is explained that they can gain insight with this application. * "Courtesy meditation: the 'difficult' person", "compassion and breathing: yourself" and "compassionate breathing: others" practices are made

Other: Session 5: Me and others - Expanding the circle

Session 6: Growing happiness

EXPERIMENTAL

* "Revisiting the good" practice is carried out to define the five sense organs for the participants. * "Forgiveness", "Asking for forgiveness", "forgiving others", "gratitude" practices are carried out. * The practice is expanded as "kindness meditation: groups and all beings".

Other: Session 6: Growing happiness

Session 7: Weaving Wisdom and Compassion into Daily Life

EXPERIMENTAL

* Participants are made to choose a day in their life and allow a few minutes to pause in a mindful way. * "A breather for wise and compassionate action", "calmness meditation" and "joy sharing meditation" practices are carried out.

Other: Session 7: Weaving Wisdom and Compassion into Daily Life

Session 8: Living with the Heart

EXPERIMENTAL

* The participants are told about the applications that they can apply for, where they need help to develop compassion towards self-healing skills, and the whole training is evaluated. * The "river of life" application, which evaluates mindfulness in depth, is carried out. * An overall summary of the 8-session study is made and feedback is received.

Other: Session 8: Living with the Heart

Interventions

The practice of "Breath break with kindness" will be applied for 5 minutes. Afterwards, 15 minutes of information on threats, impulses and soothing systems, "A safe place" application for 11 minutes, "Courtesy meditation" for 10 minutes. After each application, 10 minutes of feedback will be received from the participants.

Session 1: How We Evolved - Threat, Impulse, and Soothing Systems

The practice of "breathing with kindness" will be done for 7 minutes. The practice of "Building a compassionate relationship with resilience" will be held for 12 minutes, and the practice of "Kindness meditation: a benevolent" will take place for 11 minutes. "A hand over your heart" application will be made for 3 minutes and "A compassionate comrade" application will be done for 10 minutes. After each application, 3 minutes of feedback will be received from the participants.

Session 2: Threat and Self-Compassion

The practice of "breathing with kindness" will be done for 7 minutes. "Building a compassionate relationship with desire" 12 minutes, "Guided meditation to discover the inner pattern" 10 minutes and "Courtesy meditation: a good friend" 11 minutes. Except for the "breath break with kindness" application, 3 minutes of feedback will be received from the participants after each application

Session 3: Unraveling the Knots of Desire and Patterns Agenda

The "pretend-to-be" practice for the participants to observe themselves will be made for 10 minutes. The practice of "internalizing compassion" will be done for 7 minutes, "kindness meditation: a neutral person" practice for 10 minutes, and "kindness towards your body" for 10 minutes. After each application, 3 minutes of feedback will be received from the participants.

Session 4: Internalizing compassion

The "a compassionate letter" practice with the participants will continue for 15 minutes. "meditation: the 'difficult' person" 8 minutes, "compassion and breathing: yourself" 10 minutes and "compassionate breathing: others" 7 minutes. A "compassionate break" application is performed for 7 minutes.

Session 5: Me and others - Expanding the circle

The practice of "Revisiting the good" is carried out for 10 minutes with the participants. "Forgive yourself", "wish for forgiveness", "forgive others", "gratitude" practices will be held for 5 minutes each and will take 20 minutes in total. "Courtesy meditation: groups and all beings" will be practiced for 10 minutes. After each application, 3 minutes of feedback will be received from the participants.

Session 6: Growing happiness

Participants will be given 10 minutes to choose a day in their life and allow a few minutes to pause mindfully. The practice of "a breather for wise and compassionate action" is 10 minutes, the practice of "calmness meditation" is 8 minutes, and the practice of "sharing the joy meditation" is 8 minutes. After each application, 3 minutes of feedback will be received from the participants.

Session 7: Weaving Wisdom and Compassion into Daily Life

The participants are told about the applications they can apply for, where they need help to develop compassion towards self-healing skills, and the entire training will be evaluated for 20 minutes. The "river of life" application is carried out for 20 minutes. 10 minutes of feedback will be received after the application.

Session 8: Living with the Heart

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being a caregiver to a patient in a palliative care clinic
  • Being 18 years or older
  • Willingness to participate in the study
  • Being open to communication and cooperation

You may not qualify if:

  • Not attending sessions regularly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University Faculty of Nursing

Erzurum, Yakutiye, Turkey (Türkiye)

Location

Related Publications (1)

  • Kilic D, Tosun Tasar P, Cengiz M. The effect of mindfulness-based compassionate living training for informal caregivers of palliative inpatients on burnout and caregiving burden: a randomized controlled trial. Health Educ Res. 2024 Jul 18;39(4):313-322. doi: 10.1093/her/cyae005.

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 24, 2023

First Posted

June 2, 2023

Study Start

April 17, 2023

Primary Completion

May 26, 2023

Study Completion

June 6, 2023

Last Updated

June 4, 2024

Record last verified: 2024-06

Locations