EarthquakeNCT05891223
The Effect of "Mindfulness-Based Compassionate Life Training" for University Students Affected by the Earthquake
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 Earthquake and Trauma, run by Ataturk University.
Trial summary
In this study, aimed to determine the effect of "Mindfulness Based Compassionate Life Training" given to university students on coping with post-earthquake trauma stress and grief process. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Earthquake, Trauma, Stress, Psychological
- 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 5 Feb 2024to 20 Jun 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having a university nursing education
- Being affected by the earthquake
- Willingness to participate in the study
- Being open to communication and cooperation
Who cannot join
- Not attending sessions regularly
About this study
Official title: The Effect of "Mindfulness-Based Compassionate Life Training" for University Students Affected by the Earthquake on Coping With Earthquake Trauma Stress and Grief Process
In this study, aimed to determine the effect of "Mindfulness Based Compassionate Life Training" given to university students on coping with post-earthquake trauma stress and grief process. According to the experimental design with pre-test and post-test control group, the participants selected from the universe will be assigned to the experimental and control groups impartially. In this study, a priori power analysis will be performed to determine the sample size. For the independent groups, in which the effect of "Mindfulness-Based Compassionate Life Training" on coping with post-earthquake trauma stress and grief will be compared, 80% power will be achieved at a significance level of 0.05 at a 95% confidence interval. A total of 68 participants will be reached by taking into account data losses and including 30% backup sample in the research. Participants included in the study will be numbered from 1 to 68 and 34 experimental and 34 control groups will be created from www.random.org.
Pre-test data will be collected before applying to earthquake survivors in the experimental group and control group. 8 sessions of Mindfulness Based Compassionate Life training will be given to earthquake survivors in the experimental group. Training sessions will be held online. For its effectiveness and continuity, each session will be held between 3 days and 7 days. One week after the Mindfulness-Based Compassionate Living training (after 8 sessions were completed), the "Post-earthquake Trauma Stress Level Determination Scale (NSSTDBÖ)", "The Grief Scale" was administered to the earthquake survivors. The "Self-Compassion Scale Short Form (STS-F)" post-test will be filled in by face-to-face interview. Post-test data from the experimental and control groups will be obtained simultaneously.
Read the detailed description
Research data will be collected face to face by researchers. 68 earthquake survivors who meet the inclusion criteria (to be studying at a university, to be affected by the earthquake, to be willing to participate in the study, to be open to communication and cooperation) will be included in the study. The descriptive features form consisting of 8 questions for data collection, "Post-earthquake Trauma Stress Level Detection Scale", "Mourning Scale". "Self-Compassion Scale Short Form (STS-F)" will be used. Research data will be collected as a pre-test and post-test for 1 month. Those who do not regularly participate in the Mindfulness-Based Compassionate Living training will be excluded from the study. The research will be carried out with 68 participants, 34 in the experimental group and 34 in the control group.
- Conditions
- Earthquake, Trauma, Stress, Psychological
- 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, self-compassion, Trauma, Psychological
- Medical subject headings
- Wounds and Injuries, Stress, Psychological
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 SystemsOther
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-CompassionOther
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 PatternsOther
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 compassionOther
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 circleOther
The "a compassionate letter" practice with the participants will continue for 15 minutes. "Courtesy 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 happinessOther
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 LifeOther
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 HeartOther
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: Other: 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: Other: 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: Other: 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: Other: 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: Other: 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: Other: 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: Other: 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: Other: 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 8 questions containing information about the students affected by the earthquake created by the researcher within the scope of the literature. The form created, gender, place of residence, the state of being together with the parents, whether the parents are alive or not, the place where they stayed during the earthquake (home, dormitory, etc.) to what extent they were affected by the earthquake, the status of losing a relative in the earthquake, the status of receiving psychological support after the earthquake, more It includes questions about experiencing a traumatic event before and having a previously diagnosed psychiatric illness.
Measured: [Time Frame: up to 1 day]
Secondary outcomes (1)
Post-earthquake Trauma Stress Level Scale (DSSTDBÖ)
DSTDBÖ is a tool developed by Tanhan and Kayri (2013) to measure the stress levels experienced by individuals after an earthquake. The scale consists of 20 items. The scale was arranged with a 5-point Likert-type rating of "strongly disagree", "little agree", "moderately agree", "strongly agree".
and "totally agree" format. The lowest score that can be obtained from the scale is 20 and the highest score is 100. The increase in the scores obtained from the scale shows that the individuals' level of being affected by the earthquake also increases. The internal consistency coefficient (Cronbach's alpha) of the DSDTDS was found to be .87.
Measured: [Time Frame: up to 5 week ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start5 Feb 2024 (estimated)
- Primary completion5 Jun 2024 (estimated)
- Study completion20 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EarthquakeStudies 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, Suheyla YARALI, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891223
- Sponsor's protocol ID
- suheylayaralı
- Status last verified
- Jan 2024
- First submitted
- 26 May 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yarali S, Cengiz M, Kilic D. The effect of mindfulness-based compassionate living training on post-earthquake trauma, grief process, and self-compassion in earthquake-affected university students: a randomized controlled trial. Psychol Health Med. 2026 Mar;31(3):564-581. doi: 10.1080/13548506.2025.2552963. Epub 2025 Sep 2.
PubMed 40892898
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of "Mindfulness-Based Compassionate Life Training" for University Students Affected by the Earthquake on Coping With Earthquake Trauma Stress and Grief Process
- ClinicalTrials.gov ID
- NCT05891223
- Acronym / sponsor ID
- suheylayaralı
- Conditions
- Earthquake, Trauma, Stress, Psychological
- Keywords
- Mindfulness, self-compassion, Trauma, Psychological
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 5 Feb 2024 (estimated)
- Primary completion
- 5 Jun 2024 (estimated)
- Study completion
- 20 Jun 2024 (estimated)
- First posted
- 6 Jun 2023 (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.
In this study, aimed to determine the effect of "Mindfulness Based Compassionate Life Training" given to university students on coping with post-earthquake trauma stress and grief process. According to the experimental design with pre-test and post-test control group, the participants selected from the universe will be assigned to the experimental and control groups impartially. In this study, a priori power analysis will be performed to determine the sample size. For the independent groups, in which the effect of "Mindfulness-Based Compassionate Life Training" on coping with post-earthquake trauma stress and grief will be compared, 80% power will be achieved at a significance level of 0.05 at a 95% confidence interval. A total of 68 participants will be reached by taking into account data losses and including 30% backup sample in the research. Participants included in the study will be numbered from 1 to 68 and 34 experimental and 34 control groups will be created from www.random.org.
Pre-test data will be collected before applying to earthquake survivors in the experimental group and control group. 8 sessions of Mindfulness Based Compassionate Life training will be given to earthquake survivors in the experimental group. Training sessions will be held online. For its effectiveness and continuity, each session will be held between 3 days and 7 days. One week after the Mindfulness-Based Compassionate Living training (after 8 sessions were completed), the "Post-earthquake Trauma Stress Level Determination Scale (NSSTDBÖ)", "The Grief Scale" was administered to the earthquake survivors. The "Self-Compassion Scale Short Form (STS-F)" post-test will be filled in by face-to-face interview. Post-test data from the experimental and control groups will be obtained simultaneously.
Detailed description
Research data will be collected face to face by researchers. 68 earthquake survivors who meet the inclusion criteria (to be studying at a university, to be affected by the earthquake, to be willing to participate in the study, to be open to communication and cooperation) will be included in the study. The descriptive features form consisting of 8 questions for data collection, "Post-earthquake Trauma Stress Level Detection Scale", "Mourning Scale". "Self-Compassion Scale Short Form (STS-F)" will be used. Research data will be collected as a pre-test and post-test for 1 month. Those who do not regularly participate in the Mindfulness-Based Compassionate Living training will be excluded from the study. The research will be carried out with 68 participants, 34 in the experimental group and 34 in the control group.
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 | Other: 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 | Other: 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 | Other: 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 | Other: 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 | Other: 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 | Other: 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 | Other: 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 | Other: 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 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having a university nursing education
- Being affected by the earthquake
- Willingness to participate in the study
- Being open to communication and cooperation
Key exclusion criteria (1 listed)
- Not attending sessions regularly
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. | Other | 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. | Other | 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. | Other | 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. | Other | Session 4: Internalizing compassion |
| Session 5: Me and others - Expanding the circleThe "a compassionate letter" practice with the participants will continue for 15 minutes. "Courtesy 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. | Other | 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. | Other | 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. | Other | 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. | Other | Session 8: Living with the Heart |
Primary outcome
Introductory Information Form
Time frame: [Time Frame: up to 1 day]
The form consists of 8 questions containing information about the students affected by the earthquake created by the researcher within the scope of the literature. The form created, gender, place of residence, the state of being together with the parents, whether the parents are alive or not, the place where they stayed during the earthquake (home, dormitory, etc.) to what extent they were affected by the earthquake, the status of losing a relative in the earthquake, the status of receiving psychological support after the earthquake, more It includes questions about experiencing a traumatic event before and having a previously diagnosed psychiatric illness.
1 secondary outcome
Post-earthquake Trauma Stress Level Scale (DSSTDBÖ)
Time frame: [Time Frame: up to 5 week ]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Derived from this study: PubMed 40892898Yarali S, Cengiz M, Kilic D. The effect of mindfulness-based compassionate living training on post-earthquake trauma, grief process, and self-compassion in earthquake-affected university students: a randomized controlled trial. Psychol Health Med. 2026 Mar;31(3):564-581. doi: 10.1080/13548506.2025.2552963. Epub 2025 Sep 2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Earthquake and Trauma, 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 1 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 1 Feb 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?
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: [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?
On the ClinicalTrials.gov record for NCT05891223, which also lists 1 linked publication.
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 1 Feb 2024.