Prostate Cancer (Post Prostatectomy)NCT06687538
Effect of Education to be Provided to Patients to Undergo TURP With Mobile Application on Patient Outcomes
A study testing Mobile application in people with Prostate Cancer (Post Prostatectomy), run by Tarsus University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine the effect of mobile application training on patient outcomes (preoperative anxiety, surgical fear, postoperative pain, hemodynamic parameters, satisfaction level and length of hospital stay) in patients undergoing transurethral prostate resection surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer (Post Prostatectomy)
- What is being tested?
- Mobile application
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 10 May 2026
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older,
- Written permission to participate in the study,
- Conscious, oriented and cooperative,
- Speaks and understands Turkish,
- Literate,
- Undergoing TURP,
- No vision problems,
- Patients who or their caregivers have a phone/tablet with the ability to download mobile training
Who cannot join
- Undergoing TURP for the second time,
- Physically or mentally ill with a physical or mental illness that prevents communication,
- Underwent day surgery,
- Neither they nor their caregivers have a phone/tablet with the ability to download mobile training patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Education to be Provided to Patients to Undergo Prostate Surgery With Mobile Application on Patient Outcomes
The aim of this study was to determine the effect of mobile application training on patient outcomes (preoperative anxiety, surgical fear, postoperative pain, hemodynamic parameters, satisfaction level and length of hospital stay) in patients undergoing transurethral prostate resection surgery. It was planned as a prospective, two-arm (1:1), randomized controlled clinical trial. The study will be conducted with 68 patients in the urology clinic of a vir university hospital. Patients will be randomly assigned to the control group and the mobile application training group. Patients in the mobile application group will be trained with the mobile application, while patients in the control group will only receive routine care in the clinic. Patients assigned to the mobile application group will be introduced to the education to be given with the mobile application and the application will be downloaded to their phones/tablets. Data will be collected with the Introductory Information Form, Visual Comparison Scale, State Anxiety Scale, Hemodynamic Parameters Monitoring Form, Surgical Fear Scale and Education Satisfaction Scale. When the patient is admitted to the clinic, "Introductory Information Form", "State Anxiety Scale", and "Surgical Fear Scale" will be applied to the patients in the mobile intervention and control groups before surgical intervention, and "Hemodynamic Parameters Monitoring Form" will be completed. After the surgical intervention, "Visual Comparison Scale" and "Education Satisfaction Scale" will be applied to all patients and "Hemodynamic Parameters Monitoring Form" will be completed. The data will be analyzed in a computer environment.
Read the detailed description
The aim of this study was to determine the effect of mobile application training on patient outcomes (preoperative anxiety, surgical fear, postoperative pain, hemodynamic parameters, satisfaction level and length of hospital stay) in patients undergoing transurethral prostate resection surgery. It was planned as a prospective, two-arm (1:1), randomized controlled clinical trial. The study will be conducted with 68 patients in the urology clinic of a vir university hospital. Patients will be randomly assigned to the control group and the mobile application training group. Patients in the mobile application group will be trained with the mobile application, while patients in the control group will only receive routine care in the clinic. Patients assigned to the mobile application group will be introduced to the education to be given with the mobile application and the application will be downloaded to their phones/tablets. Data will be collected with the Introductory Information Form, Visual Comparison Scale, State Anxiety Scale, Hemodynamic Parameters Monitoring Form, Surgical Fear Scale and Education Satisfaction Scale. When the patient is admitted to the clinic, "Introductory Information Form", "State Anxiety Scale", and "Surgical Fear Scale" will be applied to the patients in the mobile intervention and control groups before surgical intervention, and "Hemodynamic Parameters Monitoring Form" will be completed. After the surgical intervention, "Visual Comparison Scale" and "Education Satisfaction Scale" will be applied to all patients and "Hemodynamic Parameters Monitoring Form" will be completed. The data will be analyzed in a computer environment. The suitability of the data for normal distribution will be evaluated by Shaphiro Wilk Test. For continuous variables with normal distribution, t-test in independent groups will be used to compare two independent group averages; Mann-Whitney U test will be used to compare continuous variables that do not show normal distribution. Statistical significance value will be taken as p<0.05.
- Conditions
- Prostate Cancer (Post Prostatectomy)
- Being tested
- Mobile application
- Keywords
- Mobile application, Patient education, Patient outcomes, Nursing, Transurethral prostate resection
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile applicationOther
The content of the mobile application training to be developed for patients who will undergo transurethral prostate resection will consist of 3 modules including preoperative, postoperative and discharge training process.
| Study group | Role | What they receive |
|---|---|---|
| Mobile application group | Experimental | When the executive (EP) goes to the patient for the procedure, he/she will fill out the "Informed Consent Form", open the envelope and find out which group the patient is in. "Introductory Information Form", 'State Anxiety Scale', 'Hemodynamic Variables Monitoring Form' and 'Surgical Fear Scale' will be completed for all patients undergoing TURP. Patients in the study group will be introduced to the training to be given with the mobile application and downloaded to their phones/tablets. According to randomization, patients in the study group will receive training with the mobile application and patients in the control group will receive routine care. In the postoperative period, "Hemodynamic Variables Monitoring Form", "Visual Analog Scale" and "Education Satisfaction Scale" will be completed for all patients. Receives: Other: Mobile application |
| Control group | No intervention | When the executive (EP) goes to the patient for the procedure, he/she will fill out the "Informed Consent Form", open the envelope and find out which group the patient is in. "Introductory Information Form", 'State Anxiety Scale', 'Hemodynamic Variables Monitoring Form' and 'Surgical Fear Scale' will be filled out for all patients who will undergo TURP. Patients in the control group will receive routine care. In the postoperative period, "Hemodynamic Variables Monitoring Form", "Visual Analog Scale" and "Education Satisfaction Scale" will be completed for all patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Visual Analog Scale: It is a scale that provides a subjective assessment of pain on a horizontal or vertical line from 0 (no pain at all)-10 (very severe pain) to evaluate the level of pain (Wewers and Lowe, 1990).
Measured: 7 months
Anxiety
The State Anxiety Scale : In this study, the DAQ, which is structured to measure momentary feelings, was used. Its Turkish validity and reliability was conducted by Öner and Le Compte in 1983. The DAQ consists of 20 questions on a four-point Likert scale. The statements in the DAQ are evaluated as not at all (1), a little (2), a lot (3) and completely (4). In this section, the statements are divided into direct and reversed statements. Inverted statements: 1st, 2nd, 5th, 5th, 8th, 8th, 10th, 11th, 15th, 16th, 19th, 20th items. The total score of the reversed statements is subtracted from the total score of the direct statements and the number 50, which is the invariant value of the DAQ, is added to the value obtained and the DAQ score is calculated. The scale score ranges between 20-80 and an increase in the score indicates an increase in the level of anxiety.
Measured: 7 months
Hemodynamic Variables
Hemodynamic Variables Monitoring Form, hemodynamic variables findings of the mobile treatment and control group before and after TURP will be recorded.
Measured: 7 months
Surgical Fear
Surgical Fear Scale: The Turkish validity and reliability study of the scale was conducted by Bağdigen and Karaman Özlü in 2018. The questionnaire, which consists of eight items, has an 11-point Likert structure ranging from 0 (I am not afraid at all) to 10 (I am very afraid). The questionnaire has two subscales indicating the fear of short-term and long-term consequences of surgery. The subscale score is obtained by summing the scores of the four items in the subscales of the questionnaire. The total score of the questionnaire will be obtained by summing the scores of the two subscales, with a minimum score of 0 and a maximum score of 80. The Cronbach alpha coefficient of the scale was found to be 0.89, 0.86 for the short-term outcomes sub-dimension and 0.87 for the long-term outcomes (Bağdiven \& Karaman Özlü, 2016).
Measured: 7 months
Education Satisfaction
Education Satisfaction Scale:It is a scale that provides a subjective assessment of pain on a horizontal or vertical line from 0 (no good at all)-10 (very severe good) to evaluate the level of patient education satisfaction
Measured: 7 months
Urinalysis results
Hemodynamic Variables Monitoring Form, complete urinalysis (density, bacteriuria, etc.) findings of the mobile treatment and control group before and after TURP will be recorded.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start1 Nov 2025
- Primary completion10 May 2026
- Study completion10 May 2026
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 Prostate Cancer (Post Prostatectomy)Studies 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
- The study was planned as a prospective, two-arm (1:1), randomized controlled trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Collaborators
- Mersin University, Necmettin Erbakan University
- Responsible party
- Principal investigator, Gamze BOZKUL, Tarsus University
- Investigators
- Murat Bozlu, Principal investigator, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687538
- Sponsor's protocol ID
- TU-BOZKUL-010
- Status last verified
- Aug 2026
- First submitted
- 9 Nov 2024
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Belarmino A, Walsh R, Alshak M, Patel N, Wu R, Hu JC. Feasibility of a Mobile Health Application To Monitor Recovery and Patient-reported Outcomes after Robot-assisted Radical Prostatectomy. Eur Urol Oncol. 2019 Jul;2(4):425-428. doi: 10.1016/j.euo.2018.08.016. Epub 2018 Sep 10.
PubMed 31277778Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
PubMed 38572751Deniz-Garcia A, Fabelo H, Rodriguez-Almeida AJ, Zamora-Zamorano G, Castro-Fernandez M, Alberiche Ruano MDP, Solvoll T, Granja C, Schopf TR, Callico GM, Soguero-Ruiz C, Wagner AM; WARIFA Consortium. Quality, Usability, and Effectiveness of mHealth Apps and the Role of Artificial Intelligence: Current Scenario and Challenges. J Med Internet Res. 2023 May 4;25:e44030. doi: 10.2196/44030.
PubMed 37140973Elterman D, Aube-Peterkin M, Evans H, Elmansy H, Meskawi M, Zorn KC, Bhojani N. UPDATE - Canadian Urological Association guideline: Male lower urinary tract symptoms/benign prostatic hyperplasia. Can Urol Assoc J. 2022 Aug;16(8):245-256. doi: 10.5489/cuaj.7906. No abstract available.
PubMed 35905485
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education to be Provided to Patients to Undergo Prostate Surgery With Mobile Application on Patient Outcomes
- ClinicalTrials.gov ID
- NCT06687538
- Acronym / sponsor ID
- TU-BOZKUL-010
- Conditions
- Prostate Cancer (Post Prostatectomy)
- Keywords
- Mobile application, Patient education, Patient outcomes, Nursing, Transurethral prostate resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Collaborators
- Mersin University, Necmettin Erbakan University
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 10 May 2026 (actual)
- Study completion
- 10 May 2026 (actual)
- First posted
- 13 Nov 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 aim of this study was to determine the effect of mobile application training on patient outcomes (preoperative anxiety, surgical fear, postoperative pain, hemodynamic parameters, satisfaction level and length of hospital stay) in patients undergoing transurethral prostate resection surgery. It was planned as a prospective, two-arm (1:1), randomized controlled clinical trial. The study will be conducted with 68 patients in the urology clinic of a vir university hospital. Patients will be randomly assigned to the control group and the mobile application training group. Patients in the mobile application group will be trained with the mobile application, while patients in the control group will only receive routine care in the clinic. Patients assigned to the mobile application group will be introduced to the education to be given with the mobile application and the application will be downloaded to their phones/tablets. Data will be collected with the Introductory Information Form, Visual Comparison Scale, State Anxiety Scale, Hemodynamic Parameters Monitoring Form, Surgical Fear Scale and Education Satisfaction Scale. When the patient is admitted to the clinic, "Introductory Information Form", "State Anxiety Scale", and "Surgical Fear Scale" will be applied to the patients in the mobile intervention and control groups before surgical intervention, and "Hemodynamic Parameters Monitoring Form" will be completed. After the surgical intervention, "Visual Comparison Scale" and "Education Satisfaction Scale" will be applied to all patients and "Hemodynamic Parameters Monitoring Form" will be completed. The data will be analyzed in a computer environment.
Detailed description
The aim of this study was to determine the effect of mobile application training on patient outcomes (preoperative anxiety, surgical fear, postoperative pain, hemodynamic parameters, satisfaction level and length of hospital stay) in patients undergoing transurethral prostate resection surgery. It was planned as a prospective, two-arm (1:1), randomized controlled clinical trial. The study will be conducted with 68 patients in the urology clinic of a vir university hospital. Patients will be randomly assigned to the control group and the mobile application training group. Patients in the mobile application group will be trained with the mobile application, while patients in the control group will only receive routine care in the clinic. Patients assigned to the mobile application group will be introduced to the education to be given with the mobile application and the application will be downloaded to their phones/tablets. Data will be collected with the Introductory Information Form, Visual Comparison Scale, State Anxiety Scale, Hemodynamic Parameters Monitoring Form, Surgical Fear Scale and Education Satisfaction Scale. When the patient is admitted to the clinic, "Introductory Information Form", "State Anxiety Scale", and "Surgical Fear Scale" will be applied to the patients in the mobile intervention and control groups before surgical intervention, and "Hemodynamic Parameters Monitoring Form" will be completed. After the surgical intervention, "Visual Comparison Scale" and "Education Satisfaction Scale" will be applied to all patients and "Hemodynamic Parameters Monitoring Form" will be completed. The data will be analyzed in a computer environment. The suitability of the data for normal distribution will be evaluated by Shaphiro Wilk Test. For continuous variables with normal distribution, t-test in independent groups will be used to compare two independent group averages; Mann-Whitney U test will be used to compare continuous variables that do not show normal distribution. Statistical significance value will be taken as p<0.05.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study was planned as a prospective, two-arm (1:1), randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Mobile application group | Experimental | Other: Mobile applicationWhen the executive (EP) goes to the patient for the procedure, he/she will fill out the "Informed Consent Form", open the envelope and find out which group the patient is in. "Introductory Information Form", 'State Anxiety Scale', 'Hemodynamic Variables Monitoring Form' and 'Surgical Fear Scale' will be completed for all patients undergoing TURP. Patients in the study group will be introduced to the training to be given with the mobile application and downloaded to their phones/tablets. According to randomization, patients in the study group will receive training with the mobile application and patients in the control group will receive routine care. In the postoperative period, "Hemodynamic Variables Monitoring Form", "Visual Analog Scale" and "Education Satisfaction Scale" will be completed for all patients. |
| Control group | No intervention | –When the executive (EP) goes to the patient for the procedure, he/she will fill out the "Informed Consent Form", open the envelope and find out which group the patient is in. "Introductory Information Form", 'State Anxiety Scale', 'Hemodynamic Variables Monitoring Form' and 'Surgical Fear Scale' will be filled out for all patients who will undergo TURP. Patients in the control group will receive routine care. In the postoperative period, "Hemodynamic Variables Monitoring Form", "Visual Analog Scale" and "Education Satisfaction Scale" will be completed for all patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age or older,
- Written permission to participate in the study,
- Conscious, oriented and cooperative,
- Speaks and understands Turkish,
- Literate,
Key exclusion criteria (4 listed)
- Undergoing TURP for the second time,
- Physically or mentally ill with a physical or mental illness that prevents communication,
- Underwent day surgery,
- Neither they nor their caregivers have a phone/tablet with the ability to download mobile training patients
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 |
|---|---|---|
| Mobile applicationThe content of the mobile application training to be developed for patients who will undergo transurethral prostate resection will consist of 3 modules including preoperative, postoperative and discharge training process. | Other | Mobile application group |
Primary outcome
Pain score
Time frame: 7 months
Visual Analog Scale: It is a scale that provides a subjective assessment of pain on a horizontal or vertical line from 0 (no pain at all)-10 (very severe pain) to evaluate the level of pain (Wewers and Lowe, 1990).
Anxiety
Time frame: 7 months
The State Anxiety Scale : In this study, the DAQ, which is structured to measure momentary feelings, was used. Its Turkish validity and reliability was conducted by Öner and Le Compte in 1983. The DAQ consists of 20 questions on a four-point Likert scale. The statements in the DAQ are evaluated as not at all (1), a little (2), a lot (3) and completely (4). In this section, the statements are divided into direct and reversed statements. Inverted statements: 1st, 2nd, 5th, 5th, 8th, 8th, 10th, 11th, 15th, 16th, 19th, 20th items. The total score of the reversed statements is subtracted from the total score of the direct statements and the number 50, which is the invariant value of the DAQ, is added to the value obtained and the DAQ score is calculated. The scale score ranges between 20-80 and an increase in the score indicates an increase in the level of anxiety.
Hemodynamic Variables
Time frame: 7 months
Hemodynamic Variables Monitoring Form, hemodynamic variables findings of the mobile treatment and control group before and after TURP will be recorded.
Surgical Fear
Time frame: 7 months
Surgical Fear Scale: The Turkish validity and reliability study of the scale was conducted by Bağdigen and Karaman Özlü in 2018. The questionnaire, which consists of eight items, has an 11-point Likert structure ranging from 0 (I am not afraid at all) to 10 (I am very afraid). The questionnaire has two subscales indicating the fear of short-term and long-term consequences of surgery. The subscale score is obtained by summing the scores of the four items in the subscales of the questionnaire. The total score of the questionnaire will be obtained by summing the scores of the two subscales, with a minimum score of 0 and a maximum score of 80. The Cronbach alpha coefficient of the scale was found to be 0.89, 0.86 for the short-term outcomes sub-dimension and 0.87 for the long-term outcomes (Bağdiven \& Karaman Özlü, 2016).
Education Satisfaction
Time frame: 7 months
Education Satisfaction Scale:It is a scale that provides a subjective assessment of pain on a horizontal or vertical line from 0 (no good at all)-10 (very severe good) to evaluate the level of patient education satisfaction
Urinalysis results
Time frame: 7 months
Hemodynamic Variables Monitoring Form, complete urinalysis (density, bacteriuria, etc.) findings of the mobile treatment and control group before and after TURP will be recorded.
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 4 Aug 2026.
- Results publication: PubMed 31277778Belarmino A, Walsh R, Alshak M, Patel N, Wu R, Hu JC. Feasibility of a Mobile Health Application To Monitor Recovery and Patient-reported Outcomes after Robot-assisted Radical Prostatectomy. Eur Urol Oncol. 2019 Jul;2(4):425-428. doi: 10.1016/j.euo.2018.08.016. Epub 2018 Sep 10.
- Results publication: PubMed 38572751Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
- Results publication: PubMed 37140973Deniz-Garcia A, Fabelo H, Rodriguez-Almeida AJ, Zamora-Zamorano G, Castro-Fernandez M, Alberiche Ruano MDP, Solvoll T, Granja C, Schopf TR, Callico GM, Soguero-Ruiz C, Wagner AM; WARIFA Consortium. Quality, Usability, and Effectiveness of mHealth Apps and the Role of Artificial Intelligence: Current Scenario and Challenges. J Med Internet Res. 2023 May 4;25:e44030. doi: 10.2196/44030.
- Results publication: PubMed 35905485Elterman D, Aube-Peterkin M, Evans H, Elmansy H, Meskawi M, Zorn KC, Bhojani N. UPDATE - Canadian Urological Association guideline: Male lower urinary tract symptoms/benign prostatic hyperplasia. Can Urol Assoc J. 2022 Aug;16(8):245-256. doi: 10.5489/cuaj.7906. No abstract available.
- Individual participant dataSharing planned: No
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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.
Murat Bozlu principal investigator
Mersin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile application in people with Prostate Cancer (Post Prostatectomy), run by Tarsus 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 8 inclusion and 4 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 4 Aug 2026. 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 score (time frame: 7 months). The study lists 6 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 NCT06687538, 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 4 Aug 2026.