The Effect of Mindfulness-Based Compassionate Living Training Given to Caregivers of Inpatients in Palliative Clinic

Study Overview
=================
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.

Detailed Description
-----------------
Research data will be collected face to face by the researcher. The study continues with caregivers of patients in 54 palliative clinics who meet the inclusion criteria (being a caregiver of the patient in the palliative clinic, being willing to participate in the research, being open to communication and cooperation). The descriptive characteristics form consisting of 10 questions, Maslach burnout scale (BBL), Caregiver Burden Scale, Self-Compassion Scale Short Form was used to collect data. The pre-test data of the research data have been collected and the training process continues. One week after the end of the training, post-test data will be collected simultaneously from the experimental and control groups. The research continues with 54 participants, 26 in the experimental group and 28 in the control group.

Official Title
-----------------
The Effect of Mindfulness-Based Compassionate Living Training Given to Informal Caregivers of Inpatients in Palliative Clinics on Burnout and Care Burden: A Randomized Controlled Study

Conditions
-----------------
Informal Caregiver

Intervention / Treatment
-----------------
* Other: Session 1: How We Evolved - Threat, Impulse, and Soothing Systems
* Other: Session 2: Threat and Self-Compassion
* Other: Session 3: Unraveling the Knots of Desire and Patterns
* Other: Session 4: Internalizing compassion
* Other: Session 5: Me and others - Expanding the circle
* Other: Session 6: Growing happiness
* Other: Session 7: Weaving Wisdom and Compassion into Daily Life
* Other: Session 8: Living with the Heart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: Not attending sessions regularly

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Session 1: How We Evolved - Threat, Impulse, and Soothing Systems<br>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<br>* 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.<br>|
| Experimental: Session 2: Threat and Self-Compassion<br>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<br>* 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.<br>|
| Experimental: Session 3: Unraveling the Knots of Desire and Patterns Agenda<br>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<br>* 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<br>|
| Experimental: Session 4: Internalizing compassion<br>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<br>* 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.<br>|
| Experimental: Session 5: Me and others - Expanding the circle<br>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<br>* 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.<br>|
| Experimental: Session 6: Growing happiness<br>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<br>* 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.<br>|
| Experimental: Session 7: Weaving Wisdom and Compassion into Daily Life<br>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<br>* 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.<br>|
| Experimental: Session 8: Living with the Heart<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maslach Burnout Scale | The scale was developed by Maslach and Jackson in 1981 and was adapted into Turkish by Ergin (1992). There are 22 items in the original form of the scale and these items are collected in three dimensions. There are 9 items in the dimension of Emotional Exhaustion, 8 items in the dimension of Personal Achievement, and 5 items in the dimension of Depersonalization. Each subscale is scored separately. High scores on the Emotional Exhaustion and Depersonalization subscales and low scores on the Personal Achievement subscale indicate high levels of burnout. The scale is a 5-point Likert-type scale and should be answered as never (0), rarely (1), sometimes (2), often (3), always (4) according to the severity of the items. The Cronbach Alpha reliability coefficients for the sub-dimensions of the scale were calculated as 0.83 for Emotional Exhaustion, 0.72 for Depersonalization, and 0.67 for Personal Success. | up to 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Caregiving burden, Mindfulness, Palliative care, Informal Caregiver, Burnout