Psychological BurnoutNCT05601908
A Virtual Reality Relaxation Intervention for Clinical Staff
A study testing Virtual Reality Relaxation in people with Psychological Burnout and Stress, Psychological, run by King's College London at 1 site in United Kingdom.
Trial summary
Clinical staff working in mental health services experience high levels of work-related stress, burnout and poor wellbeing. They may work long hours, experience stress directly related to the emotional demands of the role and clinical responsibility, experience physical and psychological burnout and may experience… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Burnout, Stress, Psychological, Mental Health Burden
- What is being tested?
- Virtual Reality Relaxation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2022to 30 Dec 2023
- 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
- Clinical staff affiliated with South London and Maudsley National Health Service Trust (SLaM) and working in inpatient and outpatient mental health settings
- Aged 18 years or older
- Capacity to provide informed consent.
Who cannot join
- Staff with a history of epilepsy as there is a possibility that an epileptic episode may be generated by the VR equipment
- Is aged <18 years old.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
South London and Maudsley NHS Trust
London, Greater London, BR3 3BX
About this study
Official title: Feasibility and Acceptability of a Virtual Reality Relaxation Intervention for Mental Health Staff
Clinical staff working in mental health services experience high levels of work-related stress, burnout and poor wellbeing. They may work long hours, experience stress directly related to the emotional demands of the role and clinical responsibility, experience physical and psychological burnout and may experience high rates of workplace violence. Poorer wellbeing and high burnout amongst mental health staff has been associated with poorer quality of patient care, higher absenteeism, higher turnover rates, and low morale. Virtual reality (VR) relaxation is a technique whereby experiences of pleasant/ calming environments are accessed via a head mounted display to promote relaxation. The use of VR relaxation facilities in the workplace may provide a pragmatic approach to enabling employees to de-stress, relax and optimise their mental wellbeing and may reduce turnover and improve stress related sick leave across the National Health Service (NHS) workforce.
The research will involve a pre-post-test of 5-weeks of VR relaxation for clinical staff working in mental health settings, including those working in inpatient settings and community teams. The pre-post-test will act as a feasibility trial, the primary aim is thereby to determine whether VR relaxation is feasible and acceptable amongst mental health staff. This feasibility study will evaluate the feasibility and acceptability of a 5-week course of weekly 20-minute sessions of VR relaxation for clinical staff. Feasibility and acceptability measures will be collected and summarised at the end of the trial, including percentage of those recruited who consent to take part, completion and drop-out rates, adverse events, and satisfaction with sessions. The secondary objective is to investigate the impact of the VR relaxation intervention on potential outcome measures for a randomised controlled trial (RCT), including perceived psychological stress, worry, psychological burnout, sleep quality and anxiety. The results from this study will inform a later trial by providing key parameters including recruitment, retention, acceptability, and adherence to the treatment protocol. Additionally, follow-up qualitative interviews will be conducted with staff who engaged in the VR and staff who withdrew, to develop an understanding of attitudes towards the VR relaxation intervention.
Read the detailed description
Participants: Clinical staff affiliated within South London and Maudsley NHS Trust (SLaM) and working in inpatient and outpatient mental health settings will be recruited. The investigators anticipate recruiting 20-25 participants to the study. This number is based on recruiting a big-enough sample to assess the feasibility of the study and of the resources available.
Procedure: The study will be advertised to prospective participants via a general email to staff via the clinical team leader and email circulars. Posters will be displayed in staff rooms with a request that anyone interested in taking part contact the research team. Staff who display an interest in the study will be emailed a participant information sheet with study details. Once participants have provided online written informed consent to take part, they will be asked to undergo baseline assessments. Baseline assessments will be conducted online using Qualtrics and include: a socio-demographic questionnaire (age, gender, ethnicity, occupation, clinical setting, years of experience, highest level of education), measures of stress, worry, sleep, and burnout. All together, the baseline assessments will take approximately 15 mins to complete.
Following completion of baseline measures, participants will undergo a 5-week course of 20-min sessions of VR relaxation. The VR device used will be the Oculus Quest wireless head mounted display (HMD) with two handheld controllers. The HMD and software have been provided by a Germany based company called Magic Horizons. Participants will be asked to wear the HMD and will wear headphones to hear audio. Each session will involve participants experiencing two virtual environments designed to promote relaxation, at least one of which will have a small interactive component to aid engagement. Environments will focus on nature and will be paired with soothing music or guided meditation. For example, scenes might include dolphins dancing underwater, a beach with rock pools, waterfalls, a rainforest, green meadows with flowers, mountains with lakes and/or a sandy desert. Participants will be seated throughout all sessions. Sessions and assessments will be scheduled in working hours around the participant's clinical duties.
Before and after each session participants will be asked to complete state-measures of psychological wellbeing, and they will be asked to rate satisfaction with each session at session completion and complete a measure of sense of presence. Following completion of the 5-week VR relaxation course, participants will repeat baseline measures of stress, worry, burnout and sleep. Participants who drop out of the intervention will be invited to complete these measures providing they attend a minimum of one VR session. The investigators endeavour to complete pre-assessment measures within one week prior to the first VR session and end of intervention measures within one-week of participants finishing the course of VR. Study measures will be presented using the online survey platform Qualtrics. Participants will enter data independently with a member of the research time present to assist.
Follow-up Qualitative Interviews: Participants will be invited to participate in follow-up interviews and feedback regarding their experiences of the VR relaxation intervention will be sought. It is expected that 20 participants will attend a follow-up interview. Each interview will take approximately 30 minutes to complete. A series of simple open-ended questions will be asked, and participants will answer verbally. The questions will address staff's opinions regarding the acceptability and feasibility of conducting VR relaxation sessions in the workplace, aspects they enjoyed and barriers to implementation. An audio-recording will record responses to these questions when permission has been granted. The qualitative data gained from these questions will be analysed using thematic analysis to understand the main themes.
- Being tested
- Virtual Reality Relaxation
- Keywords
- virtual reality, relaxation, healthcare staff
- Medical subject headings
- Burnout, Psychological, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality RelaxationOther
Also called VR relaxation
Participants will undergo a 5-week course of 20-min sessions of VR relaxation. The VR device used will be the Oculus Quest wireless head mounted display (HMD) with two handheld controllers. The HMD and software have been provided by a Germany based company called Magic Horizons. Participants will be asked to wear the HMD and will wear headphones to hear audio. Each session will involve participants experiencing two virtual environments designed to promote relaxation, at least one of which will have a small interactive component to aid engagement. Environments will focus on nature and will be paired with soothing music or guided meditation. For example, scenes might include dolphins dancing underwater, a beach with rock pools, waterfalls, a rainforest, green meadows with flowers, mountains with lakes and/or a sandy desert. Participants will be seated throughout all sessions.
| Study group | Role | What they receive |
|---|---|---|
| VR Relaxation | Experimental | a 5-week course of 20-min sessions of VR relaxation Receives: Other: Virtual Reality Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of wards and community teams agree to hosting the project and number that do not agree to hosting the VR relaxation project
as assessed via a tally of acceptances and refusals
Measured: Through study completion, an average of 22 months
Number of people who consent to take part
as assessed via a tally of acceptances and refusals
Measured: Through study completion, an average of 22 months
Average adherence to VR relaxation sessions and assessments
as assessed via a record of number of VR sessions and number of assessments attended, and number of VR sessions and assessments not attended
Measured: Throughout length of participation in the VR trial, 5 weeks
Number of Participants With Treatment-Related Adverse Events
as assessed via a tally of all medical effects observed and all medical effects reported by participants
Measured: Through study completion, an average of 22 months
What proportion of participants adhere to the 20-min VR session
as assessed via a record of number of VR sessions completed in full (20 minutes) and number of sessions aborted before completion
Measured: Throughout length of participation in the VR trial, 5 weeks
Secondary outcomes (5)
Change in The Perceived Stress Scale (PSS-10) score
PSS-10 scores range between 0 and 40. Lower scores indicate lower perceived stress. A score of 27 or over is considered high perceived stress.
Measured: baseline, 5-weeks
Change in The Penn State Worry Questionnaire (PSWQ) score
Scores range from 16 to 80 with higher scores indicative of higher levels of trait worry. A score of 52 or above suggested the person is currently having some problems with worry
Measured: baseline, 5-weeks
Change in The Oldenburg Burnout Inventory (OLBI) score
Scores range from 16 to 64 with higher scores indicative of higher burnout. A score of 35 or above has been used to indicate a higher risk of burnout.
Measured: baseline, 5-weeks
Change in The Pittsburgh Sleep Quality Index (PSQI) score
Scores range from 0 to 21 with higher scores indicative of greater difficulty with sleep. A score of 5 or above is considered a significant sleep disturbance.
Measured: baseline, 5-weeks
What proportion of participants successfully complete their personal goal, this will be measured using the Goal Attainment Scaling (GAS)
personalized training goals (e.g. I would like to be able to sleep better) will be operationalised and measured using the GAS and the investigators will record the number of participants who complete their goal and the number who do not
Measured: baseline, 5-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start1 Dec 2022
- Primary completion30 Sep 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Psychological BurnoutStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-post-test
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Riches, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601908
- Sponsor's protocol ID
- REMAS15023
- Status last verified
- Jan 2024
- First submitted
- 7 Oct 2022
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Morse G, Salyers MP, Rollins AL, Monroe-DeVita M, Pfahler C. Burnout in mental health services: a review of the problem and its remediation. Adm Policy Ment Health. 2012 Sep;39(5):341-52. doi: 10.1007/s10488-011-0352-1.
PubMed 21533847d'Ettorre G, Pellicani V. Workplace Violence Toward Mental Healthcare Workers Employed in Psychiatric Wards. Saf Health Work. 2017 Dec;8(4):337-342. doi: 10.1016/j.shaw.2017.01.004. Epub 2017 Feb 6.
PubMed 29276631Johnson J, Hall LH, Berzins K, Baker J, Melling K, Thompson C. Mental healthcare staff well-being and burnout: A narrative review of trends, causes, implications, and recommendations for future interventions. Int J Ment Health Nurs. 2018 Feb;27(1):20-32. doi: 10.1111/inm.12416. Epub 2017 Dec 15.
PubMed 29243348Riches S, Azevedo L, Bird L, Pisani S, Valmaggia L. Virtual reality relaxation for the general population: a systematic review. Soc Psychiatry Psychiatr Epidemiol. 2021 Oct;56(10):1707-1727. doi: 10.1007/s00127-021-02110-z. Epub 2021 Jun 13.
PubMed 34120220Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011 May;45(5):626-9. doi: 10.1016/j.jpsychires.2010.10.008. Epub 2010 Oct 28.
PubMed 21035130
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of a Virtual Reality Relaxation Intervention for Mental Health Staff
- ClinicalTrials.gov ID
- NCT05601908
- Acronym / sponsor ID
- REMAS15023
- Keywords
- virtual reality, relaxation, healthcare staff
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 1 Nov 2022 (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.
Clinical staff working in mental health services experience high levels of work-related stress, burnout and poor wellbeing. They may work long hours, experience stress directly related to the emotional demands of the role and clinical responsibility, experience physical and psychological burnout and may experience high rates of workplace violence. Poorer wellbeing and high burnout amongst mental health staff has been associated with poorer quality of patient care, higher absenteeism, higher turnover rates, and low morale. Virtual reality (VR) relaxation is a technique whereby experiences of pleasant/ calming environments are accessed via a head mounted display to promote relaxation. The use of VR relaxation facilities in the workplace may provide a pragmatic approach to enabling employees to de-stress, relax and optimise their mental wellbeing and may reduce turnover and improve stress related sick leave across the National Health Service (NHS) workforce.
The research will involve a pre-post-test of 5-weeks of VR relaxation for clinical staff working in mental health settings, including those working in inpatient settings and community teams. The pre-post-test will act as a feasibility trial, the primary aim is thereby to determine whether VR relaxation is feasible and acceptable amongst mental health staff. This feasibility study will evaluate the feasibility and acceptability of a 5-week course of weekly 20-minute sessions of VR relaxation for clinical staff. Feasibility and acceptability measures will be collected and summarised at the end of the trial, including percentage of those recruited who consent to take part, completion and drop-out rates, adverse events, and satisfaction with sessions. The secondary objective is to investigate the impact of the VR relaxation intervention on potential outcome measures for a randomised controlled trial (RCT), including perceived psychological stress, worry, psychological burnout, sleep quality and anxiety. The results from this study will inform a later trial by providing key parameters including recruitment, retention, acceptability, and adherence to the treatment protocol. Additionally, follow-up qualitative interviews will be conducted with staff who engaged in the VR and staff who withdrew, to develop an understanding of attitudes towards the VR relaxation intervention.
Detailed description
Participants: Clinical staff affiliated within South London and Maudsley NHS Trust (SLaM) and working in inpatient and outpatient mental health settings will be recruited. The investigators anticipate recruiting 20-25 participants to the study. This number is based on recruiting a big-enough sample to assess the feasibility of the study and of the resources available.
Procedure: The study will be advertised to prospective participants via a general email to staff via the clinical team leader and email circulars. Posters will be displayed in staff rooms with a request that anyone interested in taking part contact the research team. Staff who display an interest in the study will be emailed a participant information sheet with study details. Once participants have provided online written informed consent to take part, they will be asked to undergo baseline assessments. Baseline assessments will be conducted online using Qualtrics and include: a socio-demographic questionnaire (age, gender, ethnicity, occupation, clinical setting, years of experience, highest level of education), measures of stress, worry, sleep, and burnout. All together, the baseline assessments will take approximately 15 mins to complete.
Following completion of baseline measures, participants will undergo a 5-week course of 20-min sessions of VR relaxation. The VR device used will be the Oculus Quest wireless head mounted display (HMD) with two handheld controllers. The HMD and software have been provided by a Germany based company called Magic Horizons. Participants will be asked to wear the HMD and will wear headphones to hear audio. Each session will involve participants experiencing two virtual environments designed to promote relaxation, at least one of which will have a small interactive component to aid engagement. Environments will focus on nature and will be paired with soothing music or guided meditation. For example, scenes might include dolphins dancing underwater, a beach with rock pools, waterfalls, a rainforest, green meadows with flowers, mountains with lakes and/or a sandy desert. Participants will be seated throughout all sessions. Sessions and assessments will be scheduled in working hours around the participant's clinical duties.
Before and after each session participants will be asked to complete state-measures of psychological wellbeing, and they will be asked to rate satisfaction with each session at session completion and complete a measure of sense of presence. Following completion of the 5-week VR relaxation course, participants will repeat baseline measures of stress, worry, burnout and sleep. Participants who drop out of the intervention will be invited to complete these measures providing they attend a minimum of one VR session. The investigators endeavour to complete pre-assessment measures within one week prior to the first VR session and end of intervention measures within one-week of participants finishing the course of VR. Study measures will be presented using the online survey platform Qualtrics. Participants will enter data independently with a member of the research time present to assist.
Follow-up Qualitative Interviews: Participants will be invited to participate in follow-up interviews and feedback regarding their experiences of the VR relaxation intervention will be sought. It is expected that 20 participants will attend a follow-up interview. Each interview will take approximately 30 minutes to complete. A series of simple open-ended questions will be asked, and participants will answer verbally. The questions will address staff's opinions regarding the acceptability and feasibility of conducting VR relaxation sessions in the workplace, aspects they enjoyed and barriers to implementation. An audio-recording will record responses to these questions when permission has been granted. The qualitative data gained from these questions will be analysed using thematic analysis to understand the main themes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-post-test
| Arm | Type | Receives |
|---|---|---|
| VR Relaxation | Experimental | Other: Virtual Reality Relaxationa 5-week course of 20-min sessions of VR relaxation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical staff affiliated with South London and Maudsley National Health Service Trust (SLaM) and working in inpatient and outpatient mental health settings
- Aged 18 years or older
- Capacity to provide informed consent.
Key exclusion criteria (2 listed)
- Staff with a history of epilepsy as there is a possibility that an epileptic episode may be generated by the VR equipment
- Is aged <18 years old.
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 |
|---|---|---|
| Virtual Reality RelaxationAlso: VR relaxationParticipants will undergo a 5-week course of 20-min sessions of VR relaxation. The VR device used will be the Oculus Quest wireless head mounted display (HMD) with two handheld controllers. The HMD and software have been provided by a Germany based company called Magic Horizons. Participants will be asked to wear the HMD and will wear headphones to hear audio. Each session will involve participants experiencing two virtual environments designed to promote relaxation, at least one of which will have a small interactive component to aid engagement. Environments will focus on nature and will be paired with soothing music or guided meditation. For example, scenes might include dolphins dancing underwater, a beach with rock pools, waterfalls, a rainforest, green meadows with flowers, mountains with lakes and/or a sandy desert. Participants will be seated throughout all sessions. | Other | VR Relaxation |
Primary outcome
Number of wards and community teams agree to hosting the project and number that do not agree to hosting the VR relaxation project
Time frame: Through study completion, an average of 22 months
as assessed via a tally of acceptances and refusals
Number of people who consent to take part
Time frame: Through study completion, an average of 22 months
as assessed via a tally of acceptances and refusals
Average adherence to VR relaxation sessions and assessments
Time frame: Throughout length of participation in the VR trial, 5 weeks
as assessed via a record of number of VR sessions and number of assessments attended, and number of VR sessions and assessments not attended
Number of Participants With Treatment-Related Adverse Events
Time frame: Through study completion, an average of 22 months
as assessed via a tally of all medical effects observed and all medical effects reported by participants
What proportion of participants adhere to the 20-min VR session
Time frame: Throughout length of participation in the VR trial, 5 weeks
as assessed via a record of number of VR sessions completed in full (20 minutes) and number of sessions aborted before completion
5 secondary outcomes
Change in The Perceived Stress Scale (PSS-10) score
Time frame: baseline, 5-weeks
Change in The Penn State Worry Questionnaire (PSWQ) score
Time frame: baseline, 5-weeks
Change in The Oldenburg Burnout Inventory (OLBI) score
Time frame: baseline, 5-weeks
Change in The Pittsburgh Sleep Quality Index (PSQI) score
Time frame: baseline, 5-weeks
What proportion of participants successfully complete their personal goal, this will be measured using the Goal Attainment Scaling (GAS)
Time frame: baseline, 5-weeks
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 30 Jan 2024.
- Background: PubMed 21533847Morse G, Salyers MP, Rollins AL, Monroe-DeVita M, Pfahler C. Burnout in mental health services: a review of the problem and its remediation. Adm Policy Ment Health. 2012 Sep;39(5):341-52. doi: 10.1007/s10488-011-0352-1.
- Background: PubMed 29276631d'Ettorre G, Pellicani V. Workplace Violence Toward Mental Healthcare Workers Employed in Psychiatric Wards. Saf Health Work. 2017 Dec;8(4):337-342. doi: 10.1016/j.shaw.2017.01.004. Epub 2017 Feb 6.
- Background: PubMed 29243348Johnson J, Hall LH, Berzins K, Baker J, Melling K, Thompson C. Mental healthcare staff well-being and burnout: A narrative review of trends, causes, implications, and recommendations for future interventions. Int J Ment Health Nurs. 2018 Feb;27(1):20-32. doi: 10.1111/inm.12416. Epub 2017 Dec 15.
- Background: PubMed 34120220Riches S, Azevedo L, Bird L, Pisani S, Valmaggia L. Virtual reality relaxation for the general population: a systematic review. Soc Psychiatry Psychiatr Epidemiol. 2021 Oct;56(10):1707-1727. doi: 10.1007/s00127-021-02110-z. Epub 2021 Jun 13.
- Background: PubMed 21035130Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011 May;45(5):626-9. doi: 10.1016/j.jpsychires.2010.10.008. Epub 2010 Oct 28.
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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.
Simon Riches, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Relaxation in people with Psychological Burnout and Stress, Psychological, run by King's College London at 1 site in United Kingdom.
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 3 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 30 Jan 2024. 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 United Kingdom. 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?
Number of wards and community teams agree to hosting the project and number that do not agree to hosting the VR relaxation project (time frame: Through study completion, an average of 22 months). The study lists 5 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 NCT05601908, which also lists 5 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 30 Jan 2024.