NCT06449105

Brief Summary

There are studies evaluating the effects of mindfulness-based practices on individuals receiving HD treatment. No studies have been found on how Mindfulness Compassionate Life application reduces stress, increases self-efficacy and quality of life in individuals receiving HD treatment. Considering the stress situations experienced by individuals receiving HD treatment, it is thought that the evidence-based effect of Mindfulness Compassionate Living application on individuals\' stress, self-efficacy and quality of life is important. The population of the research will consist of 90 Hemodialysis patients who were treated in Bingöl State Hospital Dialysis Unit during the specified date range. Sample size of the research; Calculated using the GPower computer program. With the power analysis, it was calculated that at the α = 0.05 level, the effect size would be strong 150, 153 (d = 0.8) and the power of the study would be 90%, and that at least 68 patients should be included in the sample. Patients who meet the research criteria and agree to participate in the research will be randomly assigned to one experimental and one control group.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

June 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2024

Completed
Last Updated

June 7, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

June 3, 2024

Last Update Submit

June 3, 2024

Conditions

Keywords

Hemodialysis patientsMindfulnessLife qualitySelf-Efficacy

Outcome Measures

Primary Outcomes (1)

  • Introductory Information Form

    The form consists of 14 questions containing information about the patient treated in the dialysis unit, created by the researcher within the scope of the literature. The created form includes questions regarding the patient's age, gender, educational status, marital status, number of children (if any), economic status and disease process.

    up to 1 day

Secondary Outcomes (1)

  • Perceived Stress Scale

    up to 1 day

Other Outcomes (4)

  • Self-Efficacy Scale

    up to 1 day

  • Quality of Life Index-Dialysis III Version

    up to 1 day

  • Self-Compassion Scale Short Form

    up to 1 day

  • +1 more other outcomes

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: 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 Agenda

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 VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being diagnosed with chronic renal failure
  • Being over 18 years of age,
  • Being willing to participate in the study
  • Being open to communication and collaboration

You may not qualify if:

  • Having a diagnosis of acute renal failure,
  • Having a current hospital stay,
  • Lack of openness to communication and collaboration,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Mine Cengiz

    Atatürk University, Faculty of Nursing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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 doctor

Study Record Dates

First Submitted

June 3, 2024

First Posted

June 7, 2024

Study Start

June 15, 2024

Primary Completion

August 15, 2024

Study Completion

November 15, 2024

Last Updated

June 7, 2024

Record last verified: 2024-06