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Informal CaregiverMindfulnessNCT05886959

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

A study testing Session 1: How We Evolved - Threat, Impulse, and Soothing Systems, Session 2: Threat and Self-Compassion and Session 3: Unraveling the Knots of Desire and Patterns in people with Informal Caregiver, run by Ataturk University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Informal Caregiver
What is being tested?
Session 1: How We Evolved - Threat, Impulse, and Soothing Systems, Session 2: Threat and Self-Compassion and Session 3: Unraveling the Knots of Desire and Patterns
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteTurkey (Türkiye)
Study dates
17 Apr 2023to 6 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Not attending sessions regularly

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ataturk University Faculty of Nursing

    Erzurum, Yakutiye

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
Session 1: How We Evolved - Threat, Impulse, and Soothing Systems, Session 2: Threat and Self-Compassion, Session 3: Unraveling the Knots of Desire and Patterns, Session 4: Internalizing compassion, Session 5: Me and others - Expanding the circle
Keywords
Caregiving burden, Mindfulness, Palliative care, Informal Caregiver, Burnout
Medical subject headings
Burnout, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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 2: Threat and Self-CompassionOther

    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 3: Unraveling the Knots of Desire and PatternsOther

    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 4: Internalizing compassionOther

    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 5: Me and others - Expanding the circleOther

    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 6: Growing happinessOther

    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 7: Weaving Wisdom and Compassion into Daily LifeOther

    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 8: Living with the HeartOther

    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.

Study groups in NCT05886959
Study groupRoleWhat they receive
Session 1: How We Evolved - Threat, Impulse, and Soothing SystemsExperimental* 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.
Receives: Other: Session 1: How We Evolved - Threat, Impulse, and Soothing Systems
Session 2: Threat and Self-CompassionExperimental* 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.
Receives: Other: Session 2: Threat and Self-Compassion
Session 3: Unraveling the Knots of Desire and Patterns AgendaExperimental* 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.
Receives: Other: Session 3: Unraveling the Knots of Desire and Patterns
Session 4: Internalizing compassionExperimental* "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
Receives: Other: Session 4: Internalizing compassion
Session 5: Me and others - Expanding the circleExperimental* 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
Receives: Other: Session 5: Me and others - Expanding the circle
Session 6: Growing happinessExperimental* "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".
Receives: Other: Session 6: Growing happiness
Session 7: Weaving Wisdom and Compassion into Daily LifeExperimental* 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.
Receives: Other: Session 7: Weaving Wisdom and Compassion into Daily Life
Session 8: Living with the HeartExperimental* 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.
Receives: Other: Session 8: Living with the Heart

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to 1 day

Secondary outcomes (1)
  1. 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.

    Measured: up to 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2023
  2. Study start17 Apr 2023
  3. Primary completion26 May 2023
  4. Study completion6 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05886959
Sponsor's protocol ID
MCENGİZ2
Acronym
Mindfulness
Status last verified
Jun 2024
First submitted
24 May 2023
Last updated
4 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38411949

Questions about this trial

What is this clinical trial studying?

A study testing Session 1: How We Evolved - Threat, Impulse, and Soothing Systems, Session 2: Threat and Self-Compassion and Session 3: Unraveling the Knots of Desire and Patterns in people with Informal Caregiver, run by Ataturk University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Introductory Information Form (time frame: up to 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05886959, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.

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