Nurses' Perceptions of IntentionalityNCT05804110
The Effect of the Mindful Caring Education Program on Nurses' Intentionality
An observational study of Nurses' Perceptions of Intentionality and the Facilitators of Intentionality, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Intentionality is defined as the property of being about or directed toward a subject, as inherent in conscious states, beliefs, or creations of the mind. In nursing science, intentionality has been conceptualized as a dynamic and evolutionary antecedent of transpersonal caring in the mutual healing process. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nurses' Perceptions of Intentionality, the Facilitators of Intentionality, the Impediments to Intentionality
- What is being tested?
- Mindful Caring Education Program
- How many people
- 9 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Dec 2021to 28 Mar 2022
- Phase
- Observational
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Nurses who care for adult patients in clinics.
Who may be able to join
- At least 1 year of working experience in the clinic, willingness to participate in research.
Who cannot join
- The exclusion criteria were that the participants wanted to quit at any research stage and did not complete the education program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mindful Caring Education Program Based on Human Caring Theory on Nurses' Intentionality: An Action Research
Intentionality is defined as the property of being about or directed toward a subject, as inherent in conscious states, beliefs, or creations of the mind. In nursing science, intentionality has been conceptualized as a dynamic and evolutionary antecedent of transpersonal caring in the mutual healing process. Intentionality is an ongoing process of discovering the nurse's self, purpose, and mission in life. The nurse's intentionality is a dynamic concept that evolves continuously. The nurse's cultural and ethnic background, philosophical and religious beliefs, life experiences, capacity for reflection, and self-awareness influence intentionality development and expression. It is recommended that nurses be encouraged to foster self-care and seek mentors and those who will support intentional care and healing practices. Also, breathing techniques, meditation, mindfulness, and self-reflection are recommended exercises for developing intentionality. Mindfulness is one way to cultivate personal knowing, awareness, and intentionality to facilitate growth and development in a transpersonal caring relationship. However, no research has been found to increase the nurse's mindful awareness or improve intentionality in the caring relationship. In this context, this research aimed to evaluate the effectiveness of mindful caring education on nurses' intentionality.
Read the detailed description
Intentionality is defined as the property of being about or directed toward a subject, as inherent in conscious states, beliefs, or creations of the mind. In nursing science, intentionality has been conceptualized as a dynamic and evolutionary antecedent of transpersonal caring in the mutual healing process. Person experience stress, trauma, loss, and crisis in their lives in a caring relationship. These situations precipitate a need for healing. Intentionality enhances presence and brings a more profound strength and focus to each interaction. Authentic presence allows the nurse to hear the call. A nurse's goal and purposeful thought activate intentionality. The intentionality focuses on caring-healing consciousness. The nurse and person enter the caring moment. The nurse and the person enter a shared consciousness field.
Intentionality is an ongoing process of discovering the nurse's self, purpose, and mission in life. The nurse's intentionality is a dynamic concept that evolves continuously. The nurse's cultural and ethnic background, philosophical and religious beliefs, life experiences, capacity for reflection, and self-awareness influence intentionality development and expression. It is recommended that nurses be encouraged to foster self-care and seek mentors and those who will support intentional care and healing practices. Also, breathing techniques, meditation, mindfulness, and self-reflection are recommended exercises for developing intentionality. Mindfulness is one way to cultivate personal knowing, awareness, and intentionality to facilitate growth and development in a transpersonal caring relationship. Mindfulness is consistently paying attention to what is happening in the present moment. Mindfulness helps support full attention, deep understanding, and immediacy in caring practice. Practicing mindfulness, the nurse becomes fully available to see, understand, love, and care. Mindfulness facilitates attending to one's thoughts and actions in each moment to extend compassion to self, others, the world, and beyond.
Evidence shows that mindfulness-based interventions (MBI) help to reduce work-related stress, psychological distress, depression, burnout, and compassion fatigue. Also, MBI positively affects self-care awareness, emotion management, empathy satisfaction, professionals' receptivity, motivation, and responsiveness to others. However, no research has been found to increase the nurse's mindful awareness or improve intentionality in the caring relationship. The study aimed to explore nurses' perceptions of intentionality in caring relationships and the effectiveness of the mindful caring education program based on the Theory of Unitary Caring Science. In this context, the research questions are as follows:
Research Question 1. What are nurses' perceptions of intentionality in the caring relationship? Research Question 2. What are the facilitators of intentionality in the caring relationship? Research Question 3. What are the impediments to intentionality in the caring relationship? Research Question 4. Is a mindful caring education program effective in improving nurses' intentionality?
- Conditions
- Nurses' Perceptions of Intentionality, the Facilitators of Intentionality, the Impediments to Intentionality, Effectiveness of Mindful Caring Education Program
- Being tested
- Mindful Caring Education Program
- Keywords
- perceptions of intentionality, facilitators of intentionality, impediment to intentionality, mindful caring education program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Caring Education ProgramOther
A four-session education plan was prepared under the nature of action research. The Theory of Unitary Caring Science is transferred to practice through Caritas processes. In this context, ten Caritas processes and caring-healing modalities (meditation, reflection, etc.) were used in the study. The pilot study was carried out with six nurses face-to-face. The education program was conducted on an online platform. Each education took approximately 2.30-3 hours. The evaluation process in action research is an essential part of the change.
What is being measured
The primary outcome is the main question the study is designed to answer.
The perception of intentionality in the caring relationship
Since intentionality is a subjective phenomenon, one's feelings and thoughts should be analyzed with in-depth methods. For this purpose, individual interviews, observation, and vignettes were used as data collection methods. The questions in the data collection form to measure these variables are as follows:
- Semi-Structured Interview Questions Question 1. What does the concept of caring intentionality mean to you? Question 2. Do you have a caring story that has had a lasting impact on you? Could you share it with me?
- Field Notes: Encountered event/situation (place/time/person/dialogue/reactions): Observer's Comment:
- Vignettes
Questions for vignettes are as follows:
- What did you think when you saw the patient?
- Can you describe how you felt when you saw the patient?
- What is the first situation/problem you want to solve when seeing the patient?
- What would you like to do for the patient's care?
Measured: 3 month
The facilitators of intentionality in the caring relationship
Some factors facilitate intentionality in the caring relationship. These factors are seen in both the expressions and actions of the nurse. There is no objective measurement tool that can measure these factors. Therefore, this result is measured using semi-structured questions and field notes. The questions in the data collection form to measure these variables are as follows:
- Semi-Structured Interview Questions Question 1. Is there anything similar to your shared caring story facilitating your intentionality toward the patient? Could you share it with me?
- Field Notes
Encountered event/situation (place/time/person/dialogue/reactions):
Observer's Comment:
Measured: 3 month
The impediments to intentionality in the caring relationship
Some factors hinder intentionality in the caring relationship. These factors are seen in both the expressions and actions of the nurse. There is no objective measurement tool that can measure these factors. Therefore, this result is measured using semi-structured questions and field notes. The questions in the data collection form to measure these variables are as follows:
- Semi-Structured Interview Questions Question: Is there anything similar to your shared caring story that hinders your intentionality toward the patient? Could you share it with me?
- Field Notes
Encountered event/situation (place/time/person/dialogue/reactions):
Observer's Comment:
Measured: 3 month
Effectiveness of mindful caring education program
The effectiveness of the education program was evaluated using semi-structured interview questions, field notes, and vignettes. The same people filled out the same vignettes before and after the education sessions. The researchers criticized by comparing the responses given before and after the education program.
- Semi-Structured Interview Questions Question 1. What are your thoughts on a mindful caring education program?
- Field Notes Encountered event/situation (place/time/person/dialogue/reactions): Observer's Comment:
- Vignettes
Questions for vignettes are as follows:
- What did you think when you saw the patient?
- Can you describe how you felt when you saw the patient?
- What is the first situation/problem you want to solve when seeing the patient?
- What would you like to do for the patient's care?
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start29 Dec 2021
- Primary completion13 Feb 2022
- Study completion28 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Nurses' Perceptions of IntentionalityStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma DURSUN ERGEZEN, Akdeniz University
- Investigators
- FATMA DURSUN ERGEZEN, phD, Principal investigator, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804110
- Sponsor's protocol ID
- AkdenizF
- Status last verified
- Apr 2023
- First submitted
- 23 Mar 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aghebati N, Mohammadi E, Ahmadi F, Noaparast KB. Principle-based concept analysis: intentionality in holistic nursing theories. J Holist Nurs. 2015 Mar;33(1):68-83. doi: 10.1177/0898010114537402. Epub 2014 Jun 12.
PubMed 24923274Drick CA. Strengthening our awareness of presence through intentionality. Beginnings. 2014 Jun;34(3):22-4. No abstract available.
PubMed 25163192Dunn DJ. The intentionality of compassion energy. Holist Nurs Pract. 2009 Jul-Aug;23(4):222-9. doi: 10.1097/HNP.0b013e3181aecebb.
PubMed 19574759Watson J. Intentionality and caring-healing consciousness: a practice of transpersonal nursing. Holist Nurs Pract. 2002 Jul;16(4):12-9. doi: 10.1097/00004650-200207000-00005.
PubMed 12060941Zahourek RP. Intentionality in Healing--The Voices of Men in Nursing: A Grounded Theory Investigation. J Holist Nurs. 2015 Dec;33(4):308-23; quiz 324-5. doi: 10.1177/0898010115573665. Epub 2015 Mar 9.
PubMed 25755275Zahourek RP. Men in Nursing: Intention, Intentionality, Caring, and Healing: Emphasis on the Results of a Grounded Theory Study. Holist Nurs Pract. 2016 Sep-Oct;30(5):247-56. doi: 10.1097/HNP.0000000000000162.
PubMed 27501206Zahourek RP. Healing: through the lens of intentionality. Holist Nurs Pract. 2012 Jan-Feb;26(1):6-21. doi: 10.1097/HNP.0b013e31823bfe4c.
PubMed 22157505Zahourek RP. Theory: Intentionality the Matrix of Healing: A Theory Revised With Nonnurse Care Providers. J Holist Nurs. 2020 Sep;38(3):287-299. doi: 10.1177/0898010119892093. Epub 2019 Dec 9.
PubMed 31815573Deary L, Roche J, Plotkin K, Zahourek R. Intentionality and hatha yoga: an exploration of the theory of intentionality, the matrix of healing--a growth model. Holist Nurs Pract. 2011 Sep-Oct;25(5):246-53. doi: 10.1097/HNP.0b013e31822a02e0.
PubMed 21832929Zahourek RP. Intentionality: evolutionary development in healing: a grounded theory study for holistic nursing. J Holist Nurs. 2005 Mar;23(1):89-109. doi: 10.1177/0898010104272026.
PubMed 15665270
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindful Caring Education Program Based on Human Caring Theory on Nurses' Intentionality: An Action Research
- ClinicalTrials.gov ID
- NCT05804110
- Acronym / sponsor ID
- AkdenizF
- Conditions
- Nurses' Perceptions of Intentionality, the Facilitators of Intentionality, the Impediments to Intentionality, Effectiveness of Mindful Caring Education Program
- Keywords
- perceptions of intentionality, facilitators of intentionality, impediment to intentionality, mindful caring education program
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 29 Dec 2021 (actual)
- Primary completion
- 13 Feb 2022 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 7 Apr 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.
Intentionality is defined as the property of being about or directed toward a subject, as inherent in conscious states, beliefs, or creations of the mind. In nursing science, intentionality has been conceptualized as a dynamic and evolutionary antecedent of transpersonal caring in the mutual healing process. Intentionality is an ongoing process of discovering the nurse's self, purpose, and mission in life. The nurse's intentionality is a dynamic concept that evolves continuously. The nurse's cultural and ethnic background, philosophical and religious beliefs, life experiences, capacity for reflection, and self-awareness influence intentionality development and expression. It is recommended that nurses be encouraged to foster self-care and seek mentors and those who will support intentional care and healing practices. Also, breathing techniques, meditation, mindfulness, and self-reflection are recommended exercises for developing intentionality. Mindfulness is one way to cultivate personal knowing, awareness, and intentionality to facilitate growth and development in a transpersonal caring relationship. However, no research has been found to increase the nurse's mindful awareness or improve intentionality in the caring relationship. In this context, this research aimed to evaluate the effectiveness of mindful caring education on nurses' intentionality.
Detailed description
Intentionality is defined as the property of being about or directed toward a subject, as inherent in conscious states, beliefs, or creations of the mind. In nursing science, intentionality has been conceptualized as a dynamic and evolutionary antecedent of transpersonal caring in the mutual healing process. Person experience stress, trauma, loss, and crisis in their lives in a caring relationship. These situations precipitate a need for healing. Intentionality enhances presence and brings a more profound strength and focus to each interaction. Authentic presence allows the nurse to hear the call. A nurse's goal and purposeful thought activate intentionality. The intentionality focuses on caring-healing consciousness. The nurse and person enter the caring moment. The nurse and the person enter a shared consciousness field.
Intentionality is an ongoing process of discovering the nurse's self, purpose, and mission in life. The nurse's intentionality is a dynamic concept that evolves continuously. The nurse's cultural and ethnic background, philosophical and religious beliefs, life experiences, capacity for reflection, and self-awareness influence intentionality development and expression. It is recommended that nurses be encouraged to foster self-care and seek mentors and those who will support intentional care and healing practices. Also, breathing techniques, meditation, mindfulness, and self-reflection are recommended exercises for developing intentionality. Mindfulness is one way to cultivate personal knowing, awareness, and intentionality to facilitate growth and development in a transpersonal caring relationship. Mindfulness is consistently paying attention to what is happening in the present moment. Mindfulness helps support full attention, deep understanding, and immediacy in caring practice. Practicing mindfulness, the nurse becomes fully available to see, understand, love, and care. Mindfulness facilitates attending to one's thoughts and actions in each moment to extend compassion to self, others, the world, and beyond.
Evidence shows that mindfulness-based interventions (MBI) help to reduce work-related stress, psychological distress, depression, burnout, and compassion fatigue. Also, MBI positively affects self-care awareness, emotion management, empathy satisfaction, professionals' receptivity, motivation, and responsiveness to others. However, no research has been found to increase the nurse's mindful awareness or improve intentionality in the caring relationship. The study aimed to explore nurses' perceptions of intentionality in caring relationships and the effectiveness of the mindful caring education program based on the Theory of Unitary Caring Science. In this context, the research questions are as follows:
Research Question 1. What are nurses' perceptions of intentionality in the caring relationship? Research Question 2. What are the facilitators of intentionality in the caring relationship? Research Question 3. What are the impediments to intentionality in the caring relationship? Research Question 4. Is a mindful caring education program effective in improving nurses' intentionality?
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Nurses who care for adult patients in clinics.
Key inclusion criteria (1 listed)
- At least 1 year of working experience in the clinic, willingness to participate in research.
Key exclusion criteria (1 listed)
- The exclusion criteria were that the participants wanted to quit at any research stage and did not complete the education program.
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 |
|---|---|---|
| Mindful Caring Education ProgramA four-session education plan was prepared under the nature of action research. The Theory of Unitary Caring Science is transferred to practice through Caritas processes. In this context, ten Caritas processes and caring-healing modalities (meditation, reflection, etc.) were used in the study. The pilot study was carried out with six nurses face-to-face. The education program was conducted on an online platform. Each education took approximately 2.30-3 hours. The evaluation process in action research is an essential part of the change. | Other | – |
Primary outcome
The perception of intentionality in the caring relationship
Time frame: 3 month
Since intentionality is a subjective phenomenon, one's feelings and thoughts should be analyzed with in-depth methods. For this purpose, individual interviews, observation, and vignettes were used as data collection methods. The questions in the data collection form to measure these variables are as follows: 1. Semi-Structured Interview Questions Question 1. What does the concept of caring intentionality mean to you? Question 2. Do you have a caring story that has had a lasting impact on you? Could you share it with me? 2. Field Notes: Encountered event/situation (place/time/person/dialogue/reactions): Observer's Comment: 3. Vignettes Questions for vignettes are as follows: 1. What did you think when you saw the patient? 2. Can you describe how you felt when you saw the patient? 3. What is the first situation/problem you want to solve when seeing the patient? 4. What would you like to do for the patient's care?
The facilitators of intentionality in the caring relationship
Time frame: 3 month
Some factors facilitate intentionality in the caring relationship. These factors are seen in both the expressions and actions of the nurse. There is no objective measurement tool that can measure these factors. Therefore, this result is measured using semi-structured questions and field notes. The questions in the data collection form to measure these variables are as follows: 1. Semi-Structured Interview Questions Question 1. Is there anything similar to your shared caring story facilitating your intentionality toward the patient? Could you share it with me? 2. Field Notes Encountered event/situation (place/time/person/dialogue/reactions): Observer's Comment:
The impediments to intentionality in the caring relationship
Time frame: 3 month
Some factors hinder intentionality in the caring relationship. These factors are seen in both the expressions and actions of the nurse. There is no objective measurement tool that can measure these factors. Therefore, this result is measured using semi-structured questions and field notes. The questions in the data collection form to measure these variables are as follows: 1. Semi-Structured Interview Questions Question: Is there anything similar to your shared caring story that hinders your intentionality toward the patient? Could you share it with me? 2. Field Notes Encountered event/situation (place/time/person/dialogue/reactions): Observer's Comment:
Effectiveness of mindful caring education program
Time frame: 3 month
The effectiveness of the education program was evaluated using semi-structured interview questions, field notes, and vignettes. The same people filled out the same vignettes before and after the education sessions. The researchers criticized by comparing the responses given before and after the education program. 1. Semi-Structured Interview Questions Question 1. What are your thoughts on a mindful caring education program? 2. Field Notes Encountered event/situation (place/time/person/dialogue/reactions): Observer's Comment: 3. Vignettes Questions for vignettes are as follows: 1. What did you think when you saw the patient? 2. Can you describe how you felt when you saw the patient? 3. What is the first situation/problem you want to solve when seeing the patient? 4. What would you like to do for the patient's care?
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 7 Apr 2023.
- Results publication: PubMed 24923274Aghebati N, Mohammadi E, Ahmadi F, Noaparast KB. Principle-based concept analysis: intentionality in holistic nursing theories. J Holist Nurs. 2015 Mar;33(1):68-83. doi: 10.1177/0898010114537402. Epub 2014 Jun 12.
- Results publication: PubMed 25163192Drick CA. Strengthening our awareness of presence through intentionality. Beginnings. 2014 Jun;34(3):22-4. No abstract available.
- Results publication: PubMed 19574759Dunn DJ. The intentionality of compassion energy. Holist Nurs Pract. 2009 Jul-Aug;23(4):222-9. doi: 10.1097/HNP.0b013e3181aecebb.
- Results publication: PubMed 12060941Watson J. Intentionality and caring-healing consciousness: a practice of transpersonal nursing. Holist Nurs Pract. 2002 Jul;16(4):12-9. doi: 10.1097/00004650-200207000-00005.
- Results publication: PubMed 25755275Zahourek RP. Intentionality in Healing--The Voices of Men in Nursing: A Grounded Theory Investigation. J Holist Nurs. 2015 Dec;33(4):308-23; quiz 324-5. doi: 10.1177/0898010115573665. Epub 2015 Mar 9.
- Results publication: PubMed 27501206Zahourek RP. Men in Nursing: Intention, Intentionality, Caring, and Healing: Emphasis on the Results of a Grounded Theory Study. Holist Nurs Pract. 2016 Sep-Oct;30(5):247-56. doi: 10.1097/HNP.0000000000000162.
- Results publication: PubMed 22157505Zahourek RP. Healing: through the lens of intentionality. Holist Nurs Pract. 2012 Jan-Feb;26(1):6-21. doi: 10.1097/HNP.0b013e31823bfe4c.
- Results publication: PubMed 31815573Zahourek RP. Theory: Intentionality the Matrix of Healing: A Theory Revised With Nonnurse Care Providers. J Holist Nurs. 2020 Sep;38(3):287-299. doi: 10.1177/0898010119892093. Epub 2019 Dec 9.
- Results publication: PubMed 21832929Deary L, Roche J, Plotkin K, Zahourek R. Intentionality and hatha yoga: an exploration of the theory of intentionality, the matrix of healing--a growth model. Holist Nurs Pract. 2011 Sep-Oct;25(5):246-53. doi: 10.1097/HNP.0b013e31822a02e0.
- Results publication: PubMed 15665270Zahourek RP. Intentionality: evolutionary development in healing: a grounded theory study for holistic nursing. J Holist Nurs. 2005 Mar;23(1):89-109. doi: 10.1177/0898010104272026.
- Individual participant dataSharing planned: Undecided
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.
FATMA DURSUN ERGEZEN, phD principal investigator
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nurses' Perceptions of Intentionality and the Facilitators of Intentionality, run by Akdeniz 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 1 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: finished, as of the sponsor's last update on 7 Apr 2023. 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?
The perception of intentionality in the caring relationship (time frame: 3 month). The study lists 4 primary outcomes in all. 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 NCT05804110, which also lists 10 linked publications.
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 Apr 2023.