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

February 18, 2025 updated by: Mine CENGİZ, Ataturk University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
59

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Yakutiye
      • Erzurum, Yakutiye, Turkey
        • Atatürk University Faculty of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Being a caregiver of a patient in a palliative clinic,
  2. Being between the ages of 18 and 45,
  3. Being willing to participate in the study
  4. Being open to communication and cooperation

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Session 1: How We Evolved - Threat, Impulse, and Soothing Systems
  • 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
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.
Experimental: Session 2: Threat and Self-Compassion
  • 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
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.
Experimental: Session 3: Unraveling the Knots of Desire and Patterns Agenda
  • 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
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
Experimental: Session 5: Me and others - Expanding the circle
  • 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
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.
Experimental: Session 6: Growing happiness
  • "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
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
Experimental: Session 7: Weaving Wisdom and Compassion into Daily Life
  • 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
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.
Experimental: Session 8: Living with the Heart
  • 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
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.
Experimental: Session 4: Internalizing compassion
  • "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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
up to 1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
up to 1 day

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
up to 1 day
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.
up to 1 day
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.
up to 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ataturk University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Pınar Tosun Taşar (Associate Professor), Atatürk University Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 18, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MCENGİZ4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings