NCT06840301

Brief Summary

This study was planned to evaluate the effects of Mindfulness Compassionate Living training on ruminative thinking and sleep quality in informal caregivers of patients in a palliative clinic in Turkey. The data of the study will be conducted between November 2024 and April 2025 in the Palliative Clinic of Atatürk University Health Research and Application Center located in the city center of Erzurum. The universe of the study will consist of individuals between the ages of 18 and 45 who are caregivers of patients in the palliative clinic during the specified date range. The sample size of the study was calculated using the GPower computer program. In the calculation made with the power analysis at α=0.05 level, the effect size was 150, 153 (d=0.8) and the power of the study was 90%, it was calculated that at least 68 patients should be included in the sample. Patients who meet the research criteria and agree to participate in the study will be randomly assigned to one experimental and one control group.An introductory information form prepared by the researcher in line with the literature, containing the socio-demographic data of patients and their caregivers in the palliative clinic, the Ruminative Thinking Style Scale to assess the general thought tendency of individuals, the Level 2 Sleep Disorder Adult Short Form (PROMIS) to assess sleep quality, the Self-Compassion Scale Short Form (SCI-S) to assess self-compassion, and the Mindful Awareness Scale (MMIS) to assess conscious awareness will be used.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2024

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2025

Completed
Last Updated

February 21, 2025

Status Verified

February 1, 2025

Enrollment Period

20 days

First QC Date

February 18, 2025

Last Update Submit

February 18, 2025

Conditions

Keywords

MindfulnessSleep QualityRuminative Thinking

Outcome Measures

Primary Outcomes (1)

  • Introductory Information Form

    The form consists of 16 questions prepared by the researcher within the scope of the literature, including information about the patient and caregiver in the palliative clinic. The created form includes questions covering the caregiver's age, gender, place of residence, education status, social security, marital status, profession and the process in which he/she provided care to the patient.

    up to 1 day

Secondary Outcomes (1)

  • Ruminative Thinking Style Scale

    up to 1 day

Other Outcomes (3)

  • Level 2 Adult Sleep Disorder Short Form (PROMIS)

    up to 1 day

  • Self-Compassion Scale Short Form (SCI-K)

    up to 1 day

  • Conscious Awareness Scale (CAS)

    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.

Behavioral: 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.

Behavioral: 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.

Behavioral: 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.

Behavioral: 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

Behavioral: 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".

Behavioral: 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.

Behavioral: 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.

Behavioral: 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 - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being a caregiver of a patient in a palliative clinic,
  • Being between the ages of 18 and 45,
  • Being willing to participate in the study
  • Being open to communication and cooperation

You may not qualify if:

  • Having a psychiatric problem in the caregiver of a patient in a palliative clinic.
  • Not being open to communication and cooperation,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University Faculty of Nursing

Erzurum, Yakutiye, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Pınar Tosun Taşar (Associate Professor)

    Ataturk University Faculty of Medicine

    STUDY CHAIR

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 Physician

Study Record Dates

First Submitted

February 18, 2025

First Posted

February 21, 2025

Study Start

November 30, 2024

Primary Completion

December 20, 2024

Study Completion

February 18, 2025

Last Updated

February 21, 2025

Record last verified: 2025-02

Locations