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Clinical Trials/NCT06840301
NCT06840301CompletedNot Applicable

The Effect of Mindfulness Compassionate Living Training on Ruminative Thinking and Sleep Quality in Informal Caregivers of Inpatients in Palliative Clinic: a Randomized Controlled Trial

Ataturk University1 site in 1 country59 target enrollmentStarted: November 30, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
59
Locations
1
Primary Endpoint
Introductory Information Form

Study Overview

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.

Detailed Description

Research data will be collected face to face by the researcher. The study will be conducted with informal caregivers who meet the inclusion criteria (being a caregiver of the patient in a palliative clinic, being willing to participate in the research, being open to communication and cooperation). Pre-test measurement tools will be applied to the informal caregivers participating in the study. Then, Mindfulness Compassionate Living Training will be applied. Eight After the session application process, the final test data will be applied.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

Exclusion Criteria

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

Arms & Interventions

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.

Intervention: Session 1: How We Evolved - Threat, Impulse, and Soothing Systems (Behavioral)

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.

Intervention: Session 2: Threat and Self-Compassion (Behavioral)

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.

Intervention: Session 3: Unraveling the Knots of Desire and Patterns (Behavioral)

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.

Intervention: Session 4: Internalizing compassion (Behavioral)

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

Intervention: Session 5: Me and others - Expanding the circle (Behavioral)

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".

Intervention: Session 6: Growing happiness (Behavioral)

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.

Intervention: Session 7: Weaving Wisdom and Compassion into Daily Life (Behavioral)

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.

Intervention: Session 8: Living with the Heart (Behavioral)

Outcomes

Primary Outcomes

Introductory Information Form

Time Frame: up to 1 day

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.

Secondary Outcomes

  • Ruminative Thinking Style Scale(up to 1 day)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mine CENGİZ

Lecturer Physician

Ataturk University

Study Sites (1)

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