Hemodialysis PatientsNCT06449105
The Effect of Mindfulness Compassionate Living Practice on Hemodialysis Patients
A study testing 1: How We Evolved - Threat, Impulse, and Soothing Systems, Session 2: Threat and Self-Compassion and Session 3: Unraveling the Knots of Desire and Patterns Agenda in people with Hemodialysis Patients, run by Ataturk University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hemodialysis Patients
- What is being tested?
- 1: How We Evolved - Threat, Impulse, and Soothing Systems, Session 2: Threat and Self-Compassion and Session 3: Unraveling the Knots of Desire and Patterns Agenda
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2024to 15 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Having a diagnosis of acute renal failure,
- Having a current hospital stay,
- Lack of openness to communication and collaboration,
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Mindfulness Compassionate Life Practice on Stress, Self-Efficacy and Quality of Life in Hemodialysis Patients: A Randomized Controlled Study
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.
Read the detailed description
Introductory information form prepared by the researcher in line with the literature and containing the socio-demographic data of hemodialysis patients, Perceived Stress Scale (PSS) to evaluate stress, Self-Efficacy-Efficacy Scale (SEES) to evaluate self-efficacy, SF-12 Quality of Life Scale to evaluate quality of life. , Self-Compassion Scale Short Form (PSS-K) will be used to evaluate self-compassion, and Conscious Mindfulness Scale (BIPS) will be used to evaluate conscious mindfulness.
- Conditions
- Hemodialysis Patients
- Being tested
- 1: How We Evolved - Threat, Impulse, and Soothing Systems, Session 2: Threat and Self-Compassion, Session 3: Unraveling the Knots of Desire and Patterns Agenda, Session 4: Internalizing compassion, Session 5: Me and others - Expanding the circle
- Keywords
- Hemodialysis patients, Mindfulness, Life quality, Self-Efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1: How We Evolved - Threat, Impulse, and Soothing SystemsBehavioural
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-CompassionBehavioural
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 AgendaBehavioural
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 compassionBehavioural
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 circleBehavioural
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 happinessBehavioural
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 LifeBehavioural
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 HeartBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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 Receives: 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 Receives: 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". Receives: 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. Receives: 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. Receives: Behavioral: Session 8: Living with the Heart |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 1 day
Secondary outcomes (1)
Perceived Stress Scale
It was developed by Cohen, Kamarck and Mermelste in 1983 to determine the perceived stress level of participants. The scale was adapted to Turkish by Bilge, Öğce, Genç and Oran (2007), and the Cronbach alpha value was found to be 0.82 in the reliability study. In the scale, some situations that include the feelings and thoughts that individuals may have experienced during the past month are given. Individuals marked the situation in each item by thinking about how much they lived during the last month. The scale is five-point Likert type. A high total score means a high level of perceived stress. In the reliability study of the scale, Cronbach's alpha value was found to be 0.86.
Measured: up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start15 Jun 2024 (estimated)
- Primary completion15 Aug 2024 (estimated)
- Study completion15 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis PatientsStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mine CENGİZ, Ataturk University
- Investigators
- Mine Cengiz, Principal investigator, Atatürk University, Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449105
- Sponsor's protocol ID
- MCENGİZ3
- Status last verified
- Jun 2024
- First submitted
- 3 Jun 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness Compassionate Life Practice on Stress, Self-Efficacy and Quality of Life in Hemodialysis Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06449105
- Acronym / sponsor ID
- MCENGİZ3
- Conditions
- Hemodialysis Patients
- Keywords
- Hemodialysis patients, Mindfulness, Life quality, Self-Efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 15 Aug 2024 (estimated)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introductory information form prepared by the researcher in line with the literature and containing the socio-demographic data of hemodialysis patients, Perceived Stress Scale (PSS) to evaluate stress, Self-Efficacy-Efficacy Scale (SEES) to evaluate self-efficacy, SF-12 Quality of Life Scale to evaluate quality of life. , Self-Compassion Scale Short Form (PSS-K) will be used to evaluate self-compassion, and Conscious Mindfulness Scale (BIPS) will be used to evaluate conscious mindfulness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Session 1: How We Evolved - Threat, Impulse, and Soothing Systems | Experimental | Behavioral: 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. |
| Session 2: Threat and Self-Compassion | Experimental | Behavioral: 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. |
| Session 3: Unraveling the Knots of Desire and Patterns Agenda | Experimental | Behavioral: 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. |
| Session 4: Internalizing compassion | Experimental | Behavioral: 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 |
| Session 5: Me and others - Expanding the circle | Experimental | Behavioral: 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 |
| Session 6: Growing happiness | Experimental | Behavioral: 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". |
| : Session 7: Weaving Wisdom and Compassion into Daily Life | Experimental | Behavioral: 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. |
| Session 8: Living with the Heart | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Having a diagnosis of acute renal failure,
- Having a current hospital stay,
- Lack of openness to communication and collaboration,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1: How We Evolved - Threat, Impulse, and Soothing SystemsThe 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. | Behavioural | Session 1: How We Evolved - Threat, Impulse, and Soothing Systems |
| Session 2: Threat and Self-CompassionThe 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. | Behavioural | Session 2: Threat and Self-Compassion |
| Session 3: Unraveling the Knots of Desire and Patterns AgendaThe 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 | Behavioural | Session 3: Unraveling the Knots of Desire and Patterns Agenda |
| Session 4: Internalizing compassionThe "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. | Behavioural | Session 4: Internalizing compassion |
| Session 5: Me and others - Expanding the circleThe "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. | Behavioural | Session 5: Me and others - Expanding the circle |
| Session 6: Growing happinessThe 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. | Behavioural | Session 6: Growing happiness |
| Session 7: Weaving Wisdom and Compassion into Daily LifeParticipants 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. | Behavioural | : Session 7: Weaving Wisdom and Compassion into Daily Life |
| Session 8: Living with the HeartThe 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. | Behavioural | Session 8: Living with the Heart |
Primary outcome
Introductory Information Form
Time frame: up to 1 day
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.
1 secondary outcome
Perceived Stress Scale
Time frame: up to 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
Related trials for Hemodialysis Patients
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Not yet recruitingPhase 1/2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
End Stage Renal Disease, Fatigue
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mine Cengiz principal investigator
Atatürk University, Faculty of Nursing
Questions about this trial
What is this clinical trial studying?
A study testing 1: How We Evolved - Threat, Impulse, and Soothing Systems, Session 2: Threat and Self-Compassion and Session 3: Unraveling the Knots of Desire and Patterns Agenda in people with Hemodialysis Patients, run by Ataturk University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mine Cengiz (05308864974, mine.cengiz@atauni.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Introductory Information Form (time frame: up to 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.