Hospital School ExperienceNCT04046692

School Activity for the Reduction of Distress, Pain and Negative Emotions in Children Experiencing Hospital School

An observational study of Hospital School Experience, run by Meyer Children's Hospital IRCCS at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Aim of present study is to evaluate the efficacy of hospital school experience in the reduction of distress, pain and negative emotion in children from 8 to 12 years old, hospitalized in oncology and pediatric wards. Read more about this study

Who is it for?: Ages 8 to 12 years
Conditions the study is for: Hospital School Experience
What is being tested?: Hospital School Experience, point of view of the children, Hospital School Experience, point of view of the hospital teachers and Hospital School Experience, point of view of the non hospital teachers
How many people: 180 participants
Where: 1 siteItaly
Study dates: 15 Mar 2017to 15 Mar 2020
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 8 to 12 years
All sexes
No healthy volunteers
Child

Study population: children 8-12 years old in oncology and pediatric wards, having hospital school into Meyer Hospital; parents of these children; hospital and not hospital teachers of the patients included in the study

Who may be able to join

age between 8 and 12 years old
knowledge of Italian language
consent for study participation
recovery
be/not be in contact with classmates (group A and group B)
Italian knowledge

Show all 13Show fewer

Being a hospital teacher
Italian knowledge
Being a teacher of the hospitalized children in the past or present time exclusion criteria for not hospital teachers:
A past experience as a hospital teacher
Italian knowledge
consent for study participation
Health or mental issues that can cause problems in completing questionnaires or answering questions

Who cannot join

patients who have already had hospital school experience in the past
cognitive disability
patients that cannot complete the study because of health or mental issues incoming during the period of the research
Have earlier experience as a hospital children in other hospitals
Cognitive disability
Health or mental issues that can cause problems in completing questionnaires or answering questions

Trial locations and contacts

1 site in 1 country.

Italy1 site

Meyer Chidren's Hospital
Florence, Firenze, 50139

Other trials in Italy

About this study

Official title: Cross - Observational Study About Hospital School Experience for the Reduction of Distress, Pain and Negative Experience and for the Promotion of School Experience's Continuity. the Point of View of Teachers, Children and Parents

Hypothesis: the investigators expect a reduction in pain, distress and negative emotions.

Read the detailed description

The school service into the hospital was born as an attempt to support emotionally, relationally and cognitively the hospitalized children, who have to spend a lot of time alone, without being educated by teachers with their classmates. There are not many studies in the Italian contest about this issue and with the present study the investigators intended to implement the acknowledgement about this theme.

The principal aim of this study is to explore if the school service reduces negative emotions experienced by oncological children as well as perceived pain and distress. To evaluate this aims, the investigators organized the study in 3 sections: the first is about the emotions experienced by oncological children between 8 and 12 years old, who benefit from the school service into the hospital; the second is about their parents' opinions and believes about the hospital school service; the third is about opinions, training and educational method dedicated by hospital school teachers and not hospital school teachers (who previously thought to our oncology children sample).

Conditions: Hospital School Experience
Being tested: Hospital School Experience, point of view of the children, Hospital School Experience, point of view of the hospital teachers, Hospital School Experience, point of view of the non hospital teachers, Hospital School Experience, point of view of parents
Keywords: hospital school, pain, distress, negative emotions, school continuity, child
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hospital School Experience, point of view of the childrenOther
Operators of the PANAS-C, PH-C and VAS ask the children to answer the questionnaire before/after the school lesson; then they ask the children to make 2 paintings about hospital and not hospital school experience.
Hospital School Experience, point of view of the hospital teachersOther
operators interview hospital teachers and make them complete a questionnaire (CEESQ)
Hospital School Experience, point of view of the non hospital teachersOther
operators interview the teachers and make them complete a questionnaire (CEESQ)
Hospital School Experience, point of view of parentsOther
Operators interview parents

Study groups in NCT04046692
Study group	Role	What they receive
children in hospital school in contact with outside school		children experience school's lesson with the hospital teacher in the school's room or into their bedrooms and the investigator give before/after the lesson 2 questionnaire (PANAS-C and PH-C) and the VAS to evaluate the aim's study. Then, the investigator asks the children to make 2 paintings: one about the hospital school experience (what is for him/her the hospital school) and one about the outside school (what he/she do/did outside during school). Receives: Other: Hospital School Experience, point of view of the children
children in hospital school NOT in contact with outside school		it's the same of the previous group ("children experiencing hospital school still in contact with outside school"); the only difference of this group is that children are not in contact with the outside school. Receives: Other: Hospital School Experience, point of view of the children
hospital teachers		teachers have to answer to some questions (qualitative interview) and fill in CEESQ schedule Receives: Other: Hospital School Experience, point of view of the hospital teachers
outside teachers		teachers have to answer to some questions (qualitative interview) and fill in CEESQ schedule Receives: Other: Hospital School Experience, point of view of the non hospital teachers
Parents		parents have to answer some questions (qualitative interview) Receives: Other: Hospital School Experience, point of view of parents

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Positive and Negative affect before/after hospital school experience
PANAS - C (Positive and Negative Affect Scale for Children): original version by Laurent (1999), italian version by Ciucci and collaborators. 30-item numerical scale assessing two dimensions (positive and negative affect, 15-item each) on a 5 point likert scale. Validated for children between 8 and 12 years old. Aim of this scale is to evaluate the presence of positive and negative emotions before/after an experience/activity.
Measured: PANAS - C is completed by the child before and after the school experience (average 3 months); it takes around 5 minutes for each investigation.
Change in Distress level before/after hospital school experience
PH - C (Psychological Hyperarousal Scale for Children): original version by Laurent (2004), italian version by Ciucci and collaborators. Numerical scale composed by 18 items measured on a 5 point Likert Scale. Aim of this scale is to evaluate the presence/absence of distress before and after the activity.
Measured: PH - C is completed by the child before and after the school experience (average 3 months); it takes around 3 minutes for each investigation.
Change in Pain level before/after hospital school experience
visual analogue scale (VAS) for children, by Scott, Ansell, \& Huskisson (1977). It's a likert scale measuring perceived pain from 0 (no pain) to 10 (maximum pain).
Measured: VAS is completed by the child before and after the school experience (average 3 months); it takes around 30 seconds for each investigation.

Secondary outcomes (8)

explorative interview for parents
it's a partially structured interview concerning ideas and opinions of parents about hospital school service
Measured: Investigators interview the parent in a silent and private room within 1 year after child's recruiting
explorative interview for hospital teachers
it's a partially structured interview concerning ideas and opinions of hospital teachers about hospital school service, methods of learning and teaching
Measured: investigators interview the hospital teacher in a silent and private room within 3 months after child's recruiting
explorative interview for outside teachers
it's a partially structured interview concerning ideas and opinions of outside teachers about hospital school service
Measured: investigators arranged an appointment to interview the teacher within 1 year after child's recruiting
research form for investigator
it's a research partially structured form regarding informations about how it's organised hospital school service
Measured: within 3 months after child's recruiting, the researcher observes a lesson and then fills in the form
research form for the outside teacher
it's a research partially structured form regarding informations about how it's organised hospital school service
Measured: through study completion, an average of 1 year, the outside teacher fill in the form after a lesson
child's emotions and ideas about hospital school service
investigators ask the child to draw the hospital school service and then is asked what he/she has drawn, what it represents, what's for him/her the best moment of hospital school
Measured: within 1 year after child's recruiting, investigators ask the child to draw when present in the Oncology Day Hospital or in the oncology/pediatric ward and then pick the draw
child's emotions and ideas about outside school service
investigators ask the child to draw the outside school service and then is asked what he has drawn, what it represents, what's for him/her the best moment of school; also, children is asked if he/she perceives a difference between outside school and hospital school service
Measured: within 1 year after child's recruiting, investigators ask the child to draw when present in the Oncology Day Hospital or in the oncology/pediatric ward and then pick the draw
emotions and self efficacy of hospital teachers
CEESQ (Crèche Educators Emotional Style Questionnaire): italian version by Ciucci, Baroncelli and Toselli (2015); numerical scale measuring emotions and self efficacy on a likert scale from 0 to 5; it takes around 10/15 minutes
Measured: the investigator asks the teacher to fill in the questionnaire, within 3 months after child's recruiting

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 201715 Mar 2020

First posted6 Aug 2019
Study start15 Mar 2017
Primary completion15 Jan 2020
Study completion15 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Hospital School ExperienceStudies of the same condition, open and under way.
More trials run by Meyer Children's Hospital IRCCSThe 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: Observational
Observational model: Case only
Time perspective: Cross-sectional
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04046692
Sponsor's protocol ID: Hospital_School
Status last verified: Oct 2024
First submitted: 29 Jul 2019
Last updated: 17 Feb 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: Decision has to be shared between Meyer Children's Hospital, University of Florence and Clinical Trial Office of Meyer Hospital

Publications

Antonelli E, Vagnoli L, Ciucci E, Vernucci C, Lachi F, Messeri A. A Comparison of Nonpharmacologic Interventions on the Emotional State of Children in the Emergency Department. Pediatr Emerg Care. 2019 Feb;35(2):81-88. doi: 10.1097/PEC.0000000000000900.
PubMed 27749803
Charlton A, Larcombe IJ, Meller ST, Morris Jones PH, Mott MG, Potton MW, Tranmer MD, Walker JJ. Absence from school related to cancer and other chronic conditions. Arch Dis Child. 1991 Oct;66(10):1217-22. doi: 10.1136/adc.66.10.1217.
PubMed 1953006
Clatworthy S, Simon K, Tiedeman ME. Child drawing: hospital--an instrument designed to measure the emotional status of hospitalized school-aged children. J Pediatr Nurs. 1999 Feb;14(1):2-9. doi: 10.1016/S0882-5963(99)80054-2.
PubMed 10063243
Clatworthy S, Simon K, Tiedeman M. Child drawing: hospital manual. J Pediatr Nurs. 1999 Feb;14(1):10-8. doi: 10.1016/S0882-5963(99)80055-4. No abstract available.
PubMed 10063244
Georgiadi, M., & Kourkoutas, E. E. (2010). Supporting pupils with cancer on their return to school: a case study report of a reintegration program. Procedia-Social and Behavioral Sciences, 5, 1288-1282.
Hughes AA, Kendall PC. Psychometric properties of the Positive and Negative Affect Scale for Children (PANAS-C) in children with anxiety disorders. Child Psychiatry Hum Dev. 2009 Sep;40(3):343-52. doi: 10.1007/s10578-009-0130-4. Epub 2009 Jan 14.
PubMed 19142724
Katz LF, Leary A, Breiger D, Friedman D. Pediatric cancer and the quality of children's dyadic peer interactions. J Pediatr Psychol. 2011 Mar;36(2):237-47. doi: 10.1093/jpepsy/jsq050. Epub 2010 Jun 2.
PubMed 20522423
Laurent J, Catanzaro SJ, Joiner TE Jr. Development and preliminary validation of the physiological hyperarousal scale for children. Psychol Assess. 2004 Dec;16(4):373-80. doi: 10.1037/1040-3590.16.4.373.
PubMed 15584796
Pelander T, Lehtonen K, Leino-Kilpi H. Children in the hospital: elements of quality in drawings. J Pediatr Nurs. 2007 Aug;22(4):333-41. doi: 10.1016/j.pedn.2007.06.004.
PubMed 17645961
af Sandeberg M, Johansson E, Bjork O, Wettergren L. Health-related quality of life relates to school attendance in children on treatment for cancer. J Pediatr Oncol Nurs. 2008 Sep-Oct;25(5):265-74. doi: 10.1177/1043454208321119. Epub 2008 Jul 22.
PubMed 18648091
Worchel-Prevatt, F. F., Heffer, R. W., Prevatt, B. C., Miner, J., Young-Saleme, T., Horgan, D., ... & Frankel, L. (1998). A school reentry program for chronically ill children. Journal of school psychology, 36(3), 261-289.
Yilmaz MC, Sari HY, Cetingul N, Kantar M, Erermis S, Aksoylar S. Determination of school-related problems in children treated for cancer. J Sch Nurs. 2014 Oct;30(5):376-84. doi: 10.1177/1059840513506942. Epub 2013 Sep 27.
PubMed 24076657

Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cross - Observational Study About Hospital School Experience for the Reduction of Distress, Pain and Negative Experience and for the Promotion of School Experience's Continuity. the Point of View of Teachers, Children and Parents
ClinicalTrials.gov ID: NCT04046692
Acronym / sponsor ID: Hospital_School
Conditions: Hospital School Experience
Keywords: hospital school, pain, distress, negative emotions, school continuity, child
Study type: Observational
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Meyer Children's Hospital IRCCSUniversity, hospital or other
Collaborators: University of Florence
Study start: 15 Mar 2017 (actual)
Primary completion: 15 Jan 2020 (actual)
Study completion: 15 Mar 2020 (actual)
First posted: 6 Aug 2019 (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.

Hypothesis: the investigators expect a reduction in pain, distress and negative emotions.

Detailed description

Study design

Observational model: Case only
Time perspective: Cross-sectional
Number of arms: 5

Arm	Type	Receives
children in hospital school in contact with outside school	–	Other: Hospital School Experience, point of view of the childrenchildren experience school's lesson with the hospital teacher in the school's room or into their bedrooms and the investigator give before/after the lesson 2 questionnaire (PANAS-C and PH-C) and the VAS to evaluate the aim's study. Then, the investigator asks the children to make 2 paintings: one about the hospital school experience (what is for him/her the hospital school) and one about the outside school (what he/she do/did outside during school).
children in hospital school NOT in contact with outside school	–	Other: Hospital School Experience, point of view of the childrenit's the same of the previous group ("children experiencing hospital school still in contact with outside school"); the only difference of this group is that children are not in contact with the outside school.
hospital teachers	–	Other: Hospital School Experience, point of view of the hospital teachersteachers have to answer to some questions (qualitative interview) and fill in CEESQ schedule
outside teachers	–	Other: Hospital School Experience, point of view of the non hospital teachersteachers have to answer to some questions (qualitative interview) and fill in CEESQ schedule
Parents	–	Other: Hospital School Experience, point of view of parentsparents have to answer some questions (qualitative interview)

Who may qualify

Ages: 8 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
Study population: children 8-12 years old in oncology and pediatric wards, having hospital school into Meyer Hospital; parents of these children; hospital and not hospital teachers of the patients included in the study

Key inclusion criteria (13 listed)

age between 8 and 12 years old
knowledge of Italian language
consent for study participation
recovery
be/not be in contact with classmates (group A and group B)

Key exclusion criteria (6 listed)

patients who have already had hospital school experience in the past
cognitive disability
patients that cannot complete the study because of health or mental issues incoming during the period of the research
Have earlier experience as a hospital children in other hospitals
Cognitive disability

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
Hospital School Experience, point of view of the childrenOperators of the PANAS-C, PH-C and VAS ask the children to answer the questionnaire before/after the school lesson; then they ask the children to make 2 paintings about hospital and not hospital school experience.	Other	children in hospital school NOT in contact with outside school, children in hospital school in contact with outside school
Hospital School Experience, point of view of the hospital teachersoperators interview hospital teachers and make them complete a questionnaire (CEESQ)	Other	hospital teachers
Hospital School Experience, point of view of the non hospital teachersoperators interview the teachers and make them complete a questionnaire (CEESQ)	Other	outside teachers
Hospital School Experience, point of view of parentsOperators interview parents	Other	Parents

Primary outcome

Change in Positive and Negative affect before/after hospital school experience
Time frame: PANAS - C is completed by the child before and after the school experience (average 3 months); it takes around 5 minutes for each investigation.
PANAS - C (Positive and Negative Affect Scale for Children): original version by Laurent (1999), italian version by Ciucci and collaborators. 30-item numerical scale assessing two dimensions (positive and negative affect, 15-item each) on a 5 point likert scale. Validated for children between 8 and 12 years old. Aim of this scale is to evaluate the presence of positive and negative emotions before/after an experience/activity.
Change in Distress level before/after hospital school experience
Time frame: PH - C is completed by the child before and after the school experience (average 3 months); it takes around 3 minutes for each investigation.
PH - C (Psychological Hyperarousal Scale for Children): original version by Laurent (2004), italian version by Ciucci and collaborators. Numerical scale composed by 18 items measured on a 5 point Likert Scale. Aim of this scale is to evaluate the presence/absence of distress before and after the activity.
Change in Pain level before/after hospital school experience
Time frame: VAS is completed by the child before and after the school experience (average 3 months); it takes around 30 seconds for each investigation.
visual analogue scale (VAS) for children, by Scott, Ansell, \& Huskisson (1977). It's a likert scale measuring perceived pain from 0 (no pain) to 10 (maximum pain).

8 secondary outcomes

explorative interview for parents
Time frame: Investigators interview the parent in a silent and private room within 1 year after child's recruiting
explorative interview for hospital teachers
Time frame: investigators interview the hospital teacher in a silent and private room within 3 months after child's recruiting
explorative interview for outside teachers
Time frame: investigators arranged an appointment to interview the teacher within 1 year after child's recruiting
research form for investigator
Time frame: within 3 months after child's recruiting, the researcher observes a lesson and then fills in the form
research form for the outside teacher
Time frame: through study completion, an average of 1 year, the outside teacher fill in the form after a lesson
child's emotions and ideas about hospital school service
Time frame: within 1 year after child's recruiting, investigators ask the child to draw when present in the Oncology Day Hospital or in the oncology/pediatric ward and then pick the draw
child's emotions and ideas about outside school service
Time frame: within 1 year after child's recruiting, investigators ask the child to draw when present in the Oncology Day Hospital or in the oncology/pediatric ward and then pick the draw
emotions and self efficacy of hospital teachers
Time frame: the investigator asks the teacher to fill in the questionnaire, within 3 months after child's recruiting

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 17 Feb 2025.
Background: PubMed 27749803Antonelli E, Vagnoli L, Ciucci E, Vernucci C, Lachi F, Messeri A. A Comparison of Nonpharmacologic Interventions on the Emotional State of Children in the Emergency Department. Pediatr Emerg Care. 2019 Feb;35(2):81-88. doi: 10.1097/PEC.0000000000000900.
Background: PubMed 1953006Charlton A, Larcombe IJ, Meller ST, Morris Jones PH, Mott MG, Potton MW, Tranmer MD, Walker JJ. Absence from school related to cancer and other chronic conditions. Arch Dis Child. 1991 Oct;66(10):1217-22. doi: 10.1136/adc.66.10.1217.
Background: PubMed 10063243Clatworthy S, Simon K, Tiedeman ME. Child drawing: hospital--an instrument designed to measure the emotional status of hospitalized school-aged children. J Pediatr Nurs. 1999 Feb;14(1):2-9. doi: 10.1016/S0882-5963(99)80054-2.
Background: PubMed 10063244Clatworthy S, Simon K, Tiedeman M. Child drawing: hospital manual. J Pediatr Nurs. 1999 Feb;14(1):10-8. doi: 10.1016/S0882-5963(99)80055-4. No abstract available.
BackgroundGeorgiadi, M., & Kourkoutas, E. E. (2010). Supporting pupils with cancer on their return to school: a case study report of a reintegration program. Procedia-Social and Behavioral Sciences, 5, 1288-1282.
Background: PubMed 19142724Hughes AA, Kendall PC. Psychometric properties of the Positive and Negative Affect Scale for Children (PANAS-C) in children with anxiety disorders. Child Psychiatry Hum Dev. 2009 Sep;40(3):343-52. doi: 10.1007/s10578-009-0130-4. Epub 2009 Jan 14.
Background: PubMed 20522423Katz LF, Leary A, Breiger D, Friedman D. Pediatric cancer and the quality of children's dyadic peer interactions. J Pediatr Psychol. 2011 Mar;36(2):237-47. doi: 10.1093/jpepsy/jsq050. Epub 2010 Jun 2.
Background: PubMed 15584796Laurent J, Catanzaro SJ, Joiner TE Jr. Development and preliminary validation of the physiological hyperarousal scale for children. Psychol Assess. 2004 Dec;16(4):373-80. doi: 10.1037/1040-3590.16.4.373.
Background: PubMed 17645961Pelander T, Lehtonen K, Leino-Kilpi H. Children in the hospital: elements of quality in drawings. J Pediatr Nurs. 2007 Aug;22(4):333-41. doi: 10.1016/j.pedn.2007.06.004.
Background: PubMed 18648091af Sandeberg M, Johansson E, Bjork O, Wettergren L. Health-related quality of life relates to school attendance in children on treatment for cancer. J Pediatr Oncol Nurs. 2008 Sep-Oct;25(5):265-74. doi: 10.1177/1043454208321119. Epub 2008 Jul 22.
BackgroundWorchel-Prevatt, F. F., Heffer, R. W., Prevatt, B. C., Miner, J., Young-Saleme, T., Horgan, D., ... & Frankel, L. (1998). A school reentry program for chronically ill children. Journal of school psychology, 36(3), 261-289.
Background: PubMed 24076657Yilmaz MC, Sari HY, Cetingul N, Kantar M, Erermis S, Aksoylar S. Determination of school-related problems in children treated for cancer. J Sch Nurs. 2014 Oct;30(5):376-84. doi: 10.1177/1059840513506942. Epub 2013 Sep 27.
Individual participant dataSharing planned: Undecided. Decision has to be shared between Meyer Children's Hospital, University of Florence and Clinical Trial Office of Meyer Hospital

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.

Rosanna Martin, MSc study director

Meyer Children's Hospital IRCCS

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 Hospital School Experience, run by Meyer Children's Hospital IRCCS at 1 site in Italy.

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 13 inclusion and 6 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 17 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 Italy. 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?

Change in Positive and Negative affect before/after hospital school experience (time frame: PANAS - C is completed by the child before and after the school experience (average 3 months); it takes around 5 minutes for each investigation.). The study lists 3 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 NCT04046692, which also lists 12 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 17 Feb 2025.