Mindfulness Compassionate Living TrainingNCT06840301
The Effect of Mindfulness Compassionate Living Training on Ruminative Thinking and Sleep Quality
A study testing Session 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 in people with Mindfulness Compassionate Living Training, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mindfulness Compassionate Living Training
- What is being tested?
- Session 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2024to 18 Feb 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Having a psychiatric problem in the caregiver of a patient in a palliative clinic.
- Not being open to communication and cooperation,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University Faculty of Nursing
Erzurum, Yakutiye
About this study
Official 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
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.
Read the 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.
- Being tested
- Session 1: How We Evolved - Threat, Impulse, and Soothing Systems, Session 2: Threat and Self-Compassion, Session 3: Unraveling the Knots of Desire and Patterns, Session 4: Internalizing compassion, Session 5: Me and others - Expanding the circle
- Keywords
- Mindfulness, Sleep Quality, Ruminative Thinking
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Session 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 PatternsBehavioural
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: Session 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 |
| 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 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.
Measured: up to 1 day
Secondary outcomes (1)
Ruminative Thinking Style Scale
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.
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 posted21 Feb 2025
- Study start30 Nov 2024
- Primary completion20 Dec 2024
- Study completion18 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mindfulness Compassionate Living TrainingStudies 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
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mine CENGİZ, Ataturk University
- Investigators
- Pınar Tosun Taşar (Associate Professor), Study chair, Ataturk University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840301
- Sponsor's protocol ID
- MCENGİZ4
- Status last verified
- Feb 2025
- First submitted
- 18 Feb 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06840301
- Acronym / sponsor ID
- MCENGİZ4
- Keywords
- Mindfulness, Sleep Quality, Ruminative Thinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 30 Nov 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 18 Feb 2025 (actual)
- First posted
- 21 Feb 2025 (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.
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
- 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: 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. |
| 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* 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
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Having a psychiatric problem in the caregiver of a patient in a palliative clinic.
- Not being open to communication and cooperation,
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 |
|---|---|---|
| Session 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 PatternsThe 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 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.
1 secondary outcome
Ruminative Thinking Style Scale
Time frame: up to 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
Pınar Tosun Taşar (Associate Professor) study chair
Ataturk University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Session 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 in people with Mindfulness Compassionate Living Training, run by Ataturk University at 1 site in Turkey (Türkiye).
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 2 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: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 21 Feb 2025.