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Completed

NCT Number: NCT06840301

The Effect of Mindfulness Compassionate Living Training on Ruminative Thinking and Sleep Quality

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.

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Key information

Conditions

Mindfulness Compassionate Living Training Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University Faculty of Nursing

Erzurum, Yakutiye, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

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

Behavioral

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-Compassion

Behavioral

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 Patterns

Behavioral

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 compassion

Behavioral

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 circle

Behavioral

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 happiness

Behavioral

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 Life

Behavioral

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 Heart

Behavioral

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.

Primary outcomes

  1. 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

  1. Ruminative Thinking Style Scale

    Time frame: up to 1 day

    The scale developed by Brinker and Dozois ignores the individual's current feelings and moods and tries to understand the general tendency of thought. This scale can also be used in other pathological conditions. The Ruminative Thinking Style Scale has a 7-point Likert-type scoring system ranging from 1 to 7, with 1 being "not descriptive at all" and 7 being "describes me very well". In this scale, participants indicate to what extent the statements in the scale reflect themselves by scoring options from 1 to 7. The Turkish version of this scale was carried out in our country by Karatepe, Yavuz and Türkcan; the Cronbach Alpha coefficient of the scale was found to be 0.90.

Other outcomes

  1. Level 2 Adult Sleep Disorder Short Form (PROMIS)

    Time frame: up to 1 day

    Sleep disturbance will be assessed using the Patient Reported Outcome Measurement Information System (PROMIS®) Short Form - Sleep Disorder. All seven items will be rated on a 5-point scale ranging from "Very poor" to "Very good" for the first item and from "Not at all" to "Very much" for all other items. Item 2 of the scale is reverse coded.

  2. Self-Compassion Scale Short Form (SCI-K)

    Time frame: up to 1 day

    The scale developed by Neff (2003) was validated and reliable in Turkish by Yıldırım and Sarı in 2018. The scale was confirmed to have a structure consisting of 11 items, a single dimension, and two complementary components (positive component and negative component). The internal consistency coefficient of the scale was calculated as .75. It is recommended that it be used in studies where the total score will be used to measure self-compassion.

  3. Conscious Awareness Scale (CAS)

    Time frame: up to 1 day

    It was developed by Brown and Ryan27 for the purpose of evaluating the BF level of individuals. In the validity and reliability study of the scale conducted in a university sample in Turkey, the Cronbach alpha coefficient was determined as 0.80.28 The scale is a one-dimensional, six-point Likert-type scale consisting of 15 questions. The minimum and maximum scores that individuals can get from the scale are between 15 and 90. High scores indicate a high BF level.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 21, 2025
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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