FibromyalgiaEFESAPQLNCT06239779
Effects of Fibromyalgia Education on Smart Phone Addiction, Pain, and Quality of Life
A study testing Education in people with Fibromyalgia and Pain Syndrome, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The study focuses on fibromyalgia, a condition characterized by chronic pain, fatigue, and associated issues like sleep disorders, depression, and anxiety. The investigators' goal is to detect smart phone addiction among fibromyalgia patients and assess potential decreases in pain and smart phone addiction after… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Fibromyalgia, Pain Syndrome, Addiction, Mobile Phone
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jan 2024to 24 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of Fibromyalgia: Participants must have received a definitive diagnosis of fibromyalgia from a specialist. This diagnosis should have been made within the last 6 -months or they should be newly diagnosed with fibromyalgia.
- Ownership of a Smart Phone: Participants are required to own a smart phone as this is essential for aspects of the research related to smart phone addiction.
- Ability to Collaborate: Participants must be willing to actively participate in the research process, follow data collection procedures, and collaborate with the research team.
Who cannot join
- Cognitive Impairment or Severe Neurological/Psychiatric Illness: Individuals with significant cognitive impairment or severe neurological or psychiatric conditions that may affect their participation are excluded.
- Serious Health Conditions: Individuals with severe health conditions (e.g., cancer, chronic heart disease) that substantially affect their daily life and could confound the study outcomes are excluded.
- Other Addictions: Individuals with other types of addictions (e.g., alcohol, substance addiction) are not eligible for participation.
- Recent Serious Surgery or Trauma: Individuals who have undergone major surgery or experienced significant trauma recently are excluded.
- Unwillingness to Participate: Individuals who are unwilling to participate in the research process or who do not consent to be part of the study are excluded.
- Non-Compliance with Procedures: Individuals who are unable or unwilling to comply with data collection procedures as outlined by the research team are excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Fibromyalgia Education on Smart Phone Addiction, Pain, and Quality of Life in Fibromyalgia Patients: A Randomized Controlled Study
The study focuses on fibromyalgia, a condition characterized by chronic pain, fatigue, and associated issues like sleep disorders, depression, and anxiety. The investigators' goal is to detect smart phone addiction among fibromyalgia patients and assess potential decreases in pain and smart phone addiction after receiving fibromyalgia education.
Participants will report their recent exercise and screen time for the past week. They will also complete the Revised Fibromyalgia Impact Questionnaire (FIQR) to measure pain and physical function and the Smart Phone Addiction Scale-Short Version (SAS-SV) to assess smart phone use. Diaries will track daily exercise and screen time for 20 days.
Read more
The intervention group will receive fibromyalgia education, covering an overview of fibromyalgia, coping strategies, and discussions on the impact of digital addictions. This education, delivered via Microsoft PowerPoint program presentation by a physician, aims to help patients.
After 20 days, all participants will redo the FIQR and SAS-SV assessments, and diary data will be collected.
This study examines how physician-provided fibromyalgia education affects pain levels, smart phone addiction, exercise and screen times. The results will deepen our understanding of how education can enhance the lives of fibromyalgia patients and aid in developing more effective strategies to manage pain and improve their quality of life.
Read the detailed description
Fibromyalgia is a musculoskeletal disease characterized by chronic pain, fatigue, and often accompanied by sleep disorders, depression, and anxiety. This study aims to identify smart phone addiction among fibromyalgia patients and explore potential improvements in their pain and smart phone addiction after receiving fibromyalgia education.
On the first day, all participants will be asked about their recent exercise duration and average screen time over the past week. They will then complete the FIQR to assess pain, quality of life and physical function in fibromyalgia, as well as the SAS-SV to measure smart phone use. Participants will receive their SAS-SV scores and be provided with diaries to record daily exercise and smart phone screen time for the next 20 days.
Patients in the intervention group will receive fibromyalgia education, which includes an overview of fibromyalgia, coping strategies (exercise, sleep management, stress reduction), and discussions on the impact of digital addictions like smart phone addiction on quality of life and stress levels. This education, presented as a face-to-face individual based Microsoft PowerPoint slide show, will be delivered by the researcher physician.
At the 20th-day follow-up, all participants will again complete the FIQR questionnaire and SAS-SV scale, and data from their diaries will be collected for further analysis.
This study aims to assess how fibromyalgia education provided by a physician affects pain levels, smart phone addiction (measured by FIQR and SAS-SV), exercise frequency, and daily screen time based on patient diaries. The findings will contribute to our understanding of how brief fibromyalgia education may impact the daily lives of patients and help develop more effective strategies to alleviate pain and enhance the quality of life for individuals with fibromyalgia.
- Conditions
- Fibromyalgia, Pain Syndrome, Addiction, Mobile Phone
- Being tested
- Education
- Keywords
- fibromyalgia, education, pain, phone addiction
- Medical subject headings
- Fibromyalgia, Somatoform Disorders, Technology Addiction, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
The education intervention will involve a PowerPoint presentation delivered individually by a physician to each participant in intervention group, covering an overview of fibromyalgia, coping strategies, and the potential impact of smart phone addiction on fibromyalgia.
| Study group | Role | What they receive |
|---|---|---|
| Education Group | Experimental | The Education Group will be comprised of study participants who will receive an educational intervention aimed at enhancing their understanding and management of fibromyalgia. This group is designed to assess the impact of fibromyalgia education on various aspects of participants' well-being, including pain levels, smart phone addiction, and daily activities.
Participants in the Education Group will attend an educational session. The educational content will cover the following key topics: an overview of fibromyalgia, coping strategies and potential harmful effects of smart phone addiction on fibromyalgia.
The primary objective of the Education Group is to evaluate the influence of fibromyalgia education on pain levels, quality of life and physical function (measured using the FIQR) and smart phone addiction (measured using the SAS-SV), exercise frequency and daily screen time based on participant diaries. Receives: Other: Education |
| Control Group | No intervention | The Control Group is a vital component of this study, serving as a reference group for evaluating the impact of the Education Group's intervention. Participants in this group will not receive the structured educational intervention. Instead they will follow their usual routines and receive standard care for fibromyalgia, which may include any recommendations typically offered by their healthcare providers but they are monitored similarly to the participants in the Education Group. The primary objective of the Control Group is to provide a baseline against which the effects of the educational intervention received by the Education Group can be compared. By not receiving the intervention, this group will help assess whether the educational program has a measurable impact on various aspects of participants' well-being when compared to standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Levels, Quality of Life, and Physical Function
These are measured using the Fibromyalgia Impact Questionnaire - Revised Form is a widely recognized instrument for assessing the impact of fibromyalgia on patients' lives. FIQR encompasses various dimensions, including pain levels, quality of life, and physical function. It employs a scale with a minimum value of 0, a maximum value of 100, and higher scores indicating worse outcome fibromyalgia impact. The study aims to assess the impact of fibromyalgia education on pain levels, quality of life, and physical function using this questionnaire.
Measured: This assessment is conducted at the beginning of the study (first day) and at the end of the study (20th day). Therefore, the time frame for this assessment spans from the first day to the 20th day of the study.
Smart Phone Addiction
This is measured using the Smartphone Addiction Scale-short version. The study aims to assess the impact of fibromyalgia education on smart phone addiction using this scale.
Measured: This assessment is conducted at the beginning of the study (first day) and at the end of the study (20th day). Therefore, the time frame for this assessment spans from the first day to the 20th day of the study
Secondary outcomes (2)
Exercise Frequency
This outcome is evaluated based on participant diaries. The study intends to determine how fibromyalgia education may affect participants' exercise habits.
Measured: Participants start filling out the diary on the first day of the study and continue to do so every day for the entire 20-day duration of the study. The time frame for the diary entries covers the entire 20-day period.
Daily Screen Time
This outcome is evaluated based on participants' self-reported daily screen time, retrieved from the settings of their smartphones and recorded in their diaries. The study intends to determine how fibromyalgia education may affect participants' daily screen time on smart phone.
Measured: Participants start filling out the diary on the first day of the study and continue to do so every day for the entire 20-day duration of the study. The time frame for the diary entries covers the entire 20-day period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start19 Jan 2024
- Primary completion19 Jun 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized controlled trial with a pre-post intervention (education) evaluation.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Selkin Yılmaz Muluk, Antalya Training and Research Hospital
- Investigators
- Nazlı Ölçücü, MD, Study director, Physical Medicine and Rehabilitation specialistSelkin Yılmaz Muluk, MD, Principal investigator, Antalya Ataturk State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239779
- Sponsor's protocol ID
- Antalya AtatürkStateHospital
- Acronym
- EFESAPQL
- Status last verified
- Mar 2025
- First submitted
- 26 Jan 2024
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators do not plan to share questionnaires, scales, or patient diaries as they include personal data but are open to sharing the results of the data and the statistic analysis details upon reasonable request,
Publications
Arnold LM, Bennett RM, Crofford LJ, Dean LE, Clauw DJ, Goldenberg DL, Fitzcharles MA, Paiva ES, Staud R, Sarzi-Puttini P, Buskila D, Macfarlane GJ. AAPT Diagnostic Criteria for Fibromyalgia. J Pain. 2019 Jun;20(6):611-628. doi: 10.1016/j.jpain.2018.10.008. Epub 2018 Nov 16.
PubMed 30453109Winslow BT, Vandal C, Dang L. Fibromyalgia: Diagnosis and Management. Am Fam Physician. 2023 Feb;107(2):137-144.
PubMed 36791450Nikolic A, Bukurov B, Kocic I, Vukovic M, Ladjevic N, Vrhovac M, Pavlovic Z, Grujicic J, Kisic D, Sipetic S. Smartphone addiction, sleep quality, depression, anxiety, and stress among medical students. Front Public Health. 2023 Sep 6;11:1252371. doi: 10.3389/fpubh.2023.1252371. eCollection 2023.
PubMed 37744504Kulekcioglu S, Cetin A. Social media use in patients with fibromyalgia and its effect on symptom severity and sleep quality. Adv Rheumatol. 2021 Aug 23;61(1):51. doi: 10.1186/s42358-021-00210-7.
PubMed 34425915
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fibromyalgia Education on Smart Phone Addiction, Pain, and Quality of Life in Fibromyalgia Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06239779
- Acronym / sponsor ID
- EFESAPQL / Antalya AtatürkStateHospital
- Conditions
- Fibromyalgia, Pain Syndrome, Addiction, Mobile Phone
- Keywords
- fibromyalgia, education, pain, phone addiction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 19 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 2 Feb 2024 (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.
The study focuses on fibromyalgia, a condition characterized by chronic pain, fatigue, and associated issues like sleep disorders, depression, and anxiety. The investigators' goal is to detect smart phone addiction among fibromyalgia patients and assess potential decreases in pain and smart phone addiction after receiving fibromyalgia education.
Participants will report their recent exercise and screen time for the past week. They will also complete the Revised Fibromyalgia Impact Questionnaire (FIQR) to measure pain and physical function and the Smart Phone Addiction Scale-Short Version (SAS-SV) to assess smart phone use. Diaries will track daily exercise and screen time for 20 days.
The intervention group will receive fibromyalgia education, covering an overview of fibromyalgia, coping strategies, and discussions on the impact of digital addictions. This education, delivered via Microsoft PowerPoint program presentation by a physician, aims to help patients.
After 20 days, all participants will redo the FIQR and SAS-SV assessments, and diary data will be collected.
This study examines how physician-provided fibromyalgia education affects pain levels, smart phone addiction, exercise and screen times. The results will deepen our understanding of how education can enhance the lives of fibromyalgia patients and aid in developing more effective strategies to manage pain and improve their quality of life.
Detailed description
Fibromyalgia is a musculoskeletal disease characterized by chronic pain, fatigue, and often accompanied by sleep disorders, depression, and anxiety. This study aims to identify smart phone addiction among fibromyalgia patients and explore potential improvements in their pain and smart phone addiction after receiving fibromyalgia education.
On the first day, all participants will be asked about their recent exercise duration and average screen time over the past week. They will then complete the FIQR to assess pain, quality of life and physical function in fibromyalgia, as well as the SAS-SV to measure smart phone use. Participants will receive their SAS-SV scores and be provided with diaries to record daily exercise and smart phone screen time for the next 20 days.
Patients in the intervention group will receive fibromyalgia education, which includes an overview of fibromyalgia, coping strategies (exercise, sleep management, stress reduction), and discussions on the impact of digital addictions like smart phone addiction on quality of life and stress levels. This education, presented as a face-to-face individual based Microsoft PowerPoint slide show, will be delivered by the researcher physician.
At the 20th-day follow-up, all participants will again complete the FIQR questionnaire and SAS-SV scale, and data from their diaries will be collected for further analysis.
This study aims to assess how fibromyalgia education provided by a physician affects pain levels, smart phone addiction (measured by FIQR and SAS-SV), exercise frequency, and daily screen time based on patient diaries. The findings will contribute to our understanding of how brief fibromyalgia education may impact the daily lives of patients and help develop more effective strategies to alleviate pain and enhance the quality of life for individuals with fibromyalgia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This study is a randomized controlled trial with a pre-post intervention (education) evaluation.
| Arm | Type | Receives |
|---|---|---|
| Education Group | Experimental | Other: EducationThe Education Group will be comprised of study participants who will receive an educational intervention aimed at enhancing their understanding and management of fibromyalgia. This group is designed to assess the impact of fibromyalgia education on various aspects of participants' well-being, including pain levels, smart phone addiction, and daily activities. Participants in the Education Group will attend an educational session. The educational content will cover the following key topics: an overview of fibromyalgia, coping strategies and potential harmful effects of smart phone addiction on fibromyalgia. The primary objective of the Education Group is to evaluate the influence of fibromyalgia education on pain levels, quality of life and physical function (measured using the FIQR) and smart phone addiction (measured using the SAS-SV), exercise frequency and daily screen time based on participant diaries. |
| Control Group | No intervention | –The Control Group is a vital component of this study, serving as a reference group for evaluating the impact of the Education Group's intervention. Participants in this group will not receive the structured educational intervention. Instead they will follow their usual routines and receive standard care for fibromyalgia, which may include any recommendations typically offered by their healthcare providers but they are monitored similarly to the participants in the Education Group. The primary objective of the Control Group is to provide a baseline against which the effects of the educational intervention received by the Education Group can be compared. By not receiving the intervention, this group will help assess whether the educational program has a measurable impact on various aspects of participants' well-being when compared to standard care. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of Fibromyalgia: Participants must have received a definitive diagnosis of fibromyalgia from a specialist. This diagnosis should have been made within the last 6 -months or they should be newly diagnosed with fibromyalgia.
- Ownership of a Smart Phone: Participants are required to own a smart phone as this is essential for aspects of the research related to smart phone addiction.
- Ability to Collaborate: Participants must be willing to actively participate in the research process, follow data collection procedures, and collaborate with the research team.
Key exclusion criteria (6 listed)
- Cognitive Impairment or Severe Neurological/Psychiatric Illness: Individuals with significant cognitive impairment or severe neurological or psychiatric conditions that may affect their participation are excluded.
- Serious Health Conditions: Individuals with severe health conditions (e.g., cancer, chronic heart disease) that substantially affect their daily life and could confound the study outcomes are excluded.
- Other Addictions: Individuals with other types of addictions (e.g., alcohol, substance addiction) are not eligible for participation.
- Recent Serious Surgery or Trauma: Individuals who have undergone major surgery or experienced significant trauma recently are excluded.
- Unwillingness to Participate: Individuals who are unwilling to participate in the research process or who do not consent to be part of the study are excluded.
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 |
|---|---|---|
| EducationThe education intervention will involve a PowerPoint presentation delivered individually by a physician to each participant in intervention group, covering an overview of fibromyalgia, coping strategies, and the potential impact of smart phone addiction on fibromyalgia. | Other | Education Group |
Primary outcome
Pain Levels, Quality of Life, and Physical Function
Time frame: This assessment is conducted at the beginning of the study (first day) and at the end of the study (20th day). Therefore, the time frame for this assessment spans from the first day to the 20th day of the study.
These are measured using the Fibromyalgia Impact Questionnaire - Revised Form is a widely recognized instrument for assessing the impact of fibromyalgia on patients' lives. FIQR encompasses various dimensions, including pain levels, quality of life, and physical function. It employs a scale with a minimum value of 0, a maximum value of 100, and higher scores indicating worse outcome fibromyalgia impact. The study aims to assess the impact of fibromyalgia education on pain levels, quality of life, and physical function using this questionnaire.
Smart Phone Addiction
Time frame: This assessment is conducted at the beginning of the study (first day) and at the end of the study (20th day). Therefore, the time frame for this assessment spans from the first day to the 20th day of the study
This is measured using the Smartphone Addiction Scale-short version. The study aims to assess the impact of fibromyalgia education on smart phone addiction using this scale.
2 secondary outcomes
Exercise Frequency
Time frame: Participants start filling out the diary on the first day of the study and continue to do so every day for the entire 20-day duration of the study. The time frame for the diary entries covers the entire 20-day period.
Daily Screen Time
Time frame: Participants start filling out the diary on the first day of the study and continue to do so every day for the entire 20-day duration of the study. The time frame for the diary entries covers the entire 20-day period.
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 3 Apr 2025.
- Background: PubMed 30453109Arnold LM, Bennett RM, Crofford LJ, Dean LE, Clauw DJ, Goldenberg DL, Fitzcharles MA, Paiva ES, Staud R, Sarzi-Puttini P, Buskila D, Macfarlane GJ. AAPT Diagnostic Criteria for Fibromyalgia. J Pain. 2019 Jun;20(6):611-628. doi: 10.1016/j.jpain.2018.10.008. Epub 2018 Nov 16.
- Background: PubMed 36791450Winslow BT, Vandal C, Dang L. Fibromyalgia: Diagnosis and Management. Am Fam Physician. 2023 Feb;107(2):137-144.
- Background: PubMed 37744504Nikolic A, Bukurov B, Kocic I, Vukovic M, Ladjevic N, Vrhovac M, Pavlovic Z, Grujicic J, Kisic D, Sipetic S. Smartphone addiction, sleep quality, depression, anxiety, and stress among medical students. Front Public Health. 2023 Sep 6;11:1252371. doi: 10.3389/fpubh.2023.1252371. eCollection 2023.
- Background: PubMed 34425915Kulekcioglu S, Cetin A. Social media use in patients with fibromyalgia and its effect on symptom severity and sleep quality. Adv Rheumatol. 2021 Aug 23;61(1):51. doi: 10.1186/s42358-021-00210-7.
- Individual participant dataSharing planned: Yes. The investigators do not plan to share questionnaires, scales, or patient diaries as they include personal data but are open to sharing the results of the data and the statistic analysis details upon reasonable request,
Related trials for Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
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.
Nazlı Ölçücü, MD study director
Physical Medicine and Rehabilitation specialist
Selkin Yılmaz Muluk, MD principal investigator
Antalya Ataturk State Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Fibromyalgia and Pain Syndrome, run by Antalya Training and Research Hospital 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 3 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 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Levels, Quality of Life, and Physical Function (time frame: This assessment is conducted at the beginning of the study (first day) and at the end of the study (20th day). Therefore, the time frame for this assessment spans from the first day to the 20th day of the study.). The study lists 2 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 NCT06239779, which also lists 4 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 3 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.