Flexible CystoscopyNCT05429879
The Impact of Music on Pain and Anxiety During Flexible Cystoscopies
A study testing Preferred Music Arm and Classical Music Arm in people with Flexible Cystoscopy, run by Horizon Health Network at 1 site in Canada.
Trial summary
Background: Cystoscopy is a routine diagnostic test often performed in the outpatient Urology setting. However, patients may sometimes feel pain and anxiety during this procedure. Distraction therapies, including patient preferred music and classical music may reduce pain and anxiety associated with cystoscopy. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Flexible Cystoscopy
- What is being tested?
- Preferred Music Arm and Classical Music Arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteCanada
- Study dates
- 23 Jun 2022to 30 May 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 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All outpatient men and women needing diagnostic or surveillance flexible cystoscopy.
- 40 years or older.
- Presenting to outpatient urology clinic.
Who cannot join
- Narcotics/analgesics within the past 24 hours
- Stricture/anatomic urethra problems
- Current UTI
- Inability to complete survey or comply with experimental methods,
- Refusal to participate
- Rigid cystoscopy
- Manipulation during cystoscopy (stent removal, fulguration tumor, etc)
- Pre-existing chronic pelvic pain condition/diagnosis
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Gavin M Langille, MD, 506-636-8818, Gavin.Langille@Dal.ca
Ali A Sherazi, BMSc, 506-271-1199, Ali.Sherazi@Dal.ca
About this study
Official title: The Impact of Music on Pain and Anxiety During Flexible Cystoscopies: A Comparison Between the Patient's Preferred Music, Classical Music, and the Absence of Music
Background: Cystoscopy is a routine diagnostic test often performed in the outpatient Urology setting. However, patients may sometimes feel pain and anxiety during this procedure. Distraction therapies, including patient preferred music and classical music may reduce pain and anxiety associated with cystoscopy. However, it is unclear if patient preferred music has greater positive outcomes for patients than classical music.
Hypothesis: We hypothesize that patient preferred music during flexible cystoscopies will reduce patient self-reported pain and anxiety scores when compared to classical music and absence of music.
Read more
Objective: To assess whether a patient's preferred music reduces pain and anxiety during cystoscopies when compared to classical music and the absence of music Methods: This is a prospective randomized control study where patients undergoing flexible cystoscopy in the outpatient Urology clinic will be randomly assigned to one of three groups: Preferred music, classical music, or no music for their procedure. Differences in pain and anxiety will be assessed between groups using the Visual Analog Scale and State-Trait Anxiety Inventory scale.
Potential Benefits: Identifying and understanding non-pharmacological interventions that can reduce pain and anxiety during cystoscopies is an important task that will allow urologists to better manage these patients.
Read the detailed description
Previous studies have shown that using music as a non-pharmacological intervention is an effective, safe, and inexpensive way to address pain and anxiety in patients during cystoscopies. However few studies have compared patient outcomes between preferred music and classical music groups, and no studies have compared these groups in a North American sample population. The intent of this project is to compare pain and anxiety in those listening to their preferred music, classical music, and no music during their cystoscopy to assess what might be the optimal way to provide this non-pharmacological intervention. Identifying and understanding non-pharmacological interventions that can reduce pain and anxiety during cystoscopies is an important task that will allow urologists to better manage these patients. The purpose of this study is to assess the impact of a patient's preferred choice of music on pain and anxiety when compared to classical music and the absence of music.
The study design will included a 1:1:1 randomization with equal group membership performed for both male and female sexes. Group 1 will allow patients to listen to their preferred music choice during cystoscopy, group 2 will listen to a standardized copyright free playlist of classical music, and group 3 will listen to no music and serve as a control group. Patients will be recruited and consented on the day of the procedure prior to filling out the State Trait Anxiety Inventory (STAI) questionnaire. After their procedure, patients will fill out the STAI questionnaire; Visual Analog Scales (VAS) for pain, satisfaction, and discomfort; and Likert scales for patients to rate their music experience.
Music, when present, will be delivered via a speaker system allowing for communication between the urologist and the patient during the procedure. Only one urologist will be performing all flexible cystoscopies. Aside from the addition of music therapy for groups 1 and 2, standard of care will not be impacted.
Statistical analysis will be conducted by two-way ANCOVA comparing the mean of quantitative outcome variables between the three music groups and each sex. In the event of a significant interaction between the music and sex variables, one way-ANCOVA will be performed within each sex, followed by Bonferroni-corrected post-hoc tests.
All data will be collected and stored appropriately as according to institutional policies as well as any relevant chapters and sections of TCPS2.
Power analysis was performed to estimate the minimum sample size required to conduct the proposed ANCOVA analyses. A review of relevant literature indicated effect sizes ranging from small to large for both VAS and STAI scores. We therefore estimated our sample size using a medium effect size to provide a reasonable common ground among findings in the literature. Due to the 1:1:1 design for both sexes, we will target a sample size of 162 to allow for an equal allocation of 27 participants per group.
- Conditions
- Flexible Cystoscopy
- Being tested
- Preferred Music Arm, Classical Music Arm
- Keywords
- Flexible cystoscopy, Music therapy, Urology, Anxiety, Pain, Satisfaction, Discomfort, Preferred music, Classical music
- Medical subject headings
- Anxiety Disorders, Pain, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preferred Music ArmOther
Patients will choose their preferred music to be played during the cystoscopy procedure. No music will be played prior to or immediately after the flexible cystoscopy procedure. Music will be delivered via a speaker allowing for communication between the urologist and the patient during the procedure. Aside from addition of music, standard of care will not be impacted.
Classical Music ArmOther
A standardized playlist of copyright free classical music will be played during the cystoscopy procedure. No music will be played prior to or immediately after the flexible cystoscopy procedure. Music will be delivered via a speaker allowing for communication between the urologist and the patient during the procedure. Aside from addition of music, standard of care will not be impacted.
| Study group | Role | What they receive |
|---|---|---|
| Preferred Music Arm | Experimental | This arm will allow patients to listen to their preferred music choice during their cystoscopy. Receives: Other: Preferred Music Arm |
| Classical Music Arm | Experimental | Patients will listen to a standard playlist of copyright free classical music. Receives: Other: Classical Music Arm |
| No music Arm | No intervention | Patients will not listen to music during cystoscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Cystoscopy Anxiety Score
Anxiety score is measured using the State Trait Anxiety Inventory (STAI). The STAI consists of two questionnaires that classifies a patient's anxiety into three groups on a scale of 20 to 80. The STAI includes two component questionnaires known as State Anxiety and Trait Anxiety. Trait Anxiety corresponds with stable individual anxiety measures while State Anxiety refers to anxiety that an individual is experiencing at a specific given moment at time. As described by the State-Trait Anxiety Inventory for Adults manual, people with higher Trait Anxiety measures may have elevated State Anxiety measures as compared to people with lower Trait Anxiety. In our study, Trait Anxiety will be controlled for, since differences in Trait Anxiety may confound State Anxiety measurements due to the individual being naturally more anxious due to unrelated reasons. A higher STAI anxiety score indicates higher anxiety.
Measured: Immediately after the procedure
Change in Anxiety Score from immediately before to immediately after cystoscopy (delta STAI)
The delta State Trait Anxiety Inventory (delta STAI) is a measure of the change in STAI anxiety score immediately after the cystoscopy minus STAI anxiety score immediately prior to the cystoscopy. The delta STAI ranges on a scale from negative 60 to positive 60. A positive delta STAI score indicates that there was a greater STAI anxiety score immediately after the procedure as compared to immediately before the procedure. A higher positive delta STAI score means a greater increase in anxiety as compared to a lower delta STAI score. A negative delta STAI score indicates that there was a lower STAI anxiety score immediately after the procedure as compared to immediately before the procedure. A more negative delta STAI score indicates a greater decrease in anxiety as compared to a less negative delta STAI score. A delta STAI score of 0 indicates that there was no change in STAI anxiety score from immediately before the procedure to immediately after the procedure.
Measured: Change from immediately before the procedure to immediately after the procedure
Pelvic pain score
Pelvic pain will be measured using a Visual Analog Scale (VAS). The VAS score is completed by the patient ranking their pain intensity on 10-cm lines and providing a range of scores from 0 to 100. This measure is then converted to a score of 10 (to 1 decimal eg. 8.2/10). For this study, VAS scales will be filled out by the patient immediately following their cystoscopy. A higher VAS score indicates greater self reported pelvic pain.
Measured: Immediately after the procedure
Secondary outcomes (6)
Pelvic discomfort score
Pelvic discomfort will be measured using a Visual Analog Scale (VAS). The VAS score is completed by the patient ranking their discomfort on 10-cm lines and providing a range of scores from 0 to 100. This measure is then converted to a score of 10 (to 1 decimal eg. 8.2/10). For this study, VAS scales will be filled out in the post-procedure questionnaire by the patient immediately following their cystoscopy. A higher VAS score indicates greater self reported pelvic discomfort.
Measured: Immediately after the procedure
Patient satisfaction score
Patient satisfaction with cystoscopy will be measured using a Visual Analog Scale (VAS). The VAS score is completed by the patient ranking their satisfaction on 10-cm lines and providing a range of scores from 0 to 100. This measure is then converted to a score of 10 (to 1 decimal eg. 8.2/10). For this study, VAS scales will be filled out in the post-procedure questionnaire by the patient immediately following their cystoscopy. A higher VAS score indicates greater self reported patient satisfaction.
Measured: Immediately after the procedure
Willingness to repeat cystoscopy score
Willingness to repeat cystoscopy will be measured using a Visual Analog Scale (VAS). The VAS score is completed by the patient ranking their willingness to repeat cystoscopy on 10-cm lines and providing a range of scores from 0 to 100. This measure is then converted to a score of 10 (to 1 decimal eg. 8.2/10). For this study, VAS scales will be filled out in the post-procedure questionnaire by the patient immediately following their cystoscopy. A higher VAS score indicates greater willingness to repeat cystoscopy.
Measured: Immediately after the procedure
How pleasant patients from music intervention groups found the music
How pleasant patients found the music during their cystoscopy will be measured using a 5-point Likert scale where patients rate their agreement with the statement "I found the music pleasant". Ratings include "Strongly agree, Agree, Neither agree nor disagree, Disagree, Strongly disagree".
Measured: Immediately after the procedure
How calming patients from music intervention groups found the music
How calming patients found the music during their cystoscopy will be measured using a 5-point Likert scale where patients rate their agreement with the statement "I found the music calming". Ratings include "Strongly agree, Agree, Neither agree nor disagree, Disagree, Strongly disagree".
Measured: Immediately after the procedure
How much patients from music intervention groups found that music helped distract them from the cystoscopy procedure
How distracting patients found the music during their cystoscopy will be measured using a 5-point Likert scale where patients rate their agreement with the statement "The music helped distract me from the cystoscopy procedure". Ratings include "Strongly agree, Agree, Neither agree nor disagree, Disagree, Strongly disagree".
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start23 Jun 2022
- Primary completion30 May 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flexible CystoscopyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective randomized control study that is designed to study outcomes between subjects. Participants will be randomly assigned to one of three groups and will be stratified according to sex. Stratified randomization will be done by selection of sequential pre-filled envelopes containing the group for a particular patient at the time of cystoscopy - This is a 1:1:1 randomization with equal group membership performed for both male and female sexes - The envelopes will be randomized by pre-assigning an order of participants to each of the three groups within each sex using a Random sequence generator.
- Masking
- None (open label)
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Horizon Health Network
- Sponsor type
- University, hospital or other
- Collaborators
- Dalhousie University
- Responsible party
- Principal investigator, Gavin Langille, Horizon Health Network
- Investigators
- Gavin M Langille, MD, Principal investigator, Horizon Health Network, Dalhousie University Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429879
- Sponsor's protocol ID
- 101548
- Status last verified
- Jul 2023
- First submitted
- 26 May 2022
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Music on Pain and Anxiety During Flexible Cystoscopies: A Comparison Between the Patient's Preferred Music, Classical Music, and the Absence of Music
- ClinicalTrials.gov ID
- NCT05429879
- Acronym / sponsor ID
- 101548
- Conditions
- Flexible Cystoscopy
- Keywords
- Flexible cystoscopy, Music therapy, Urology, Anxiety, Pain, Satisfaction, Discomfort, Preferred music
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Horizon Health NetworkUniversity, hospital or other
- Collaborators
- Dalhousie University
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 23 Jun 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.
Background: Cystoscopy is a routine diagnostic test often performed in the outpatient Urology setting. However, patients may sometimes feel pain and anxiety during this procedure. Distraction therapies, including patient preferred music and classical music may reduce pain and anxiety associated with cystoscopy. However, it is unclear if patient preferred music has greater positive outcomes for patients than classical music.
Hypothesis: We hypothesize that patient preferred music during flexible cystoscopies will reduce patient self-reported pain and anxiety scores when compared to classical music and absence of music.
Objective: To assess whether a patient's preferred music reduces pain and anxiety during cystoscopies when compared to classical music and the absence of music Methods: This is a prospective randomized control study where patients undergoing flexible cystoscopy in the outpatient Urology clinic will be randomly assigned to one of three groups: Preferred music, classical music, or no music for their procedure. Differences in pain and anxiety will be assessed between groups using the Visual Analog Scale and State-Trait Anxiety Inventory scale.
Potential Benefits: Identifying and understanding non-pharmacological interventions that can reduce pain and anxiety during cystoscopies is an important task that will allow urologists to better manage these patients.
Detailed description
Previous studies have shown that using music as a non-pharmacological intervention is an effective, safe, and inexpensive way to address pain and anxiety in patients during cystoscopies. However few studies have compared patient outcomes between preferred music and classical music groups, and no studies have compared these groups in a North American sample population. The intent of this project is to compare pain and anxiety in those listening to their preferred music, classical music, and no music during their cystoscopy to assess what might be the optimal way to provide this non-pharmacological intervention. Identifying and understanding non-pharmacological interventions that can reduce pain and anxiety during cystoscopies is an important task that will allow urologists to better manage these patients. The purpose of this study is to assess the impact of a patient's preferred choice of music on pain and anxiety when compared to classical music and the absence of music.
The study design will included a 1:1:1 randomization with equal group membership performed for both male and female sexes. Group 1 will allow patients to listen to their preferred music choice during cystoscopy, group 2 will listen to a standardized copyright free playlist of classical music, and group 3 will listen to no music and serve as a control group. Patients will be recruited and consented on the day of the procedure prior to filling out the State Trait Anxiety Inventory (STAI) questionnaire. After their procedure, patients will fill out the STAI questionnaire; Visual Analog Scales (VAS) for pain, satisfaction, and discomfort; and Likert scales for patients to rate their music experience.
Music, when present, will be delivered via a speaker system allowing for communication between the urologist and the patient during the procedure. Only one urologist will be performing all flexible cystoscopies. Aside from the addition of music therapy for groups 1 and 2, standard of care will not be impacted.
Statistical analysis will be conducted by two-way ANCOVA comparing the mean of quantitative outcome variables between the three music groups and each sex. In the event of a significant interaction between the music and sex variables, one way-ANCOVA will be performed within each sex, followed by Bonferroni-corrected post-hoc tests.
All data will be collected and stored appropriately as according to institutional policies as well as any relevant chapters and sections of TCPS2.
Power analysis was performed to estimate the minimum sample size required to conduct the proposed ANCOVA analyses. A review of relevant literature indicated effect sizes ranging from small to large for both VAS and STAI scores. We therefore estimated our sample size using a medium effect size to provide a reasonable common ground among findings in the literature. Due to the 1:1:1 design for both sexes, we will target a sample size of 162 to allow for an equal allocation of 27 participants per group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a prospective randomized control study that is designed to study outcomes between subjects. Participants will be randomly assigned to one of three groups and will be stratified according to sex. Stratified randomization will be done by selection of sequential pre-filled envelopes containing the group for a particular patient at the time of cystoscopy - This is a 1:1:1 randomization with equal group membership performed for both male and female sexes - The envelopes will be randomized by pre-assigning an order of participants to each of the three groups within each sex using a Random sequence generator.
| Arm | Type | Receives |
|---|---|---|
| Preferred Music Arm | Experimental | Other: Preferred Music ArmThis arm will allow patients to listen to their preferred music choice during their cystoscopy. |
| Classical Music Arm | Experimental | Other: Classical Music ArmPatients will listen to a standard playlist of copyright free classical music. |
| No music Arm | No intervention | –Patients will not listen to music during cystoscopy. |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All outpatient men and women needing diagnostic or surveillance flexible cystoscopy.
- 40 years or older.
- Presenting to outpatient urology clinic.
Key exclusion criteria (8 listed)
- Narcotics/analgesics within the past 24 hours
- Stricture/anatomic urethra problems
- Current UTI
- Inability to complete survey or comply with experimental methods,
- Refusal to participate
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 |
|---|---|---|
| Preferred Music ArmPatients will choose their preferred music to be played during the cystoscopy procedure. No music will be played prior to or immediately after the flexible cystoscopy procedure. Music will be delivered via a speaker allowing for communication between the urologist and the patient during the procedure. Aside from addition of music, standard of care will not be impacted. | Other | Preferred Music Arm |
| Classical Music ArmA standardized playlist of copyright free classical music will be played during the cystoscopy procedure. No music will be played prior to or immediately after the flexible cystoscopy procedure. Music will be delivered via a speaker allowing for communication between the urologist and the patient during the procedure. Aside from addition of music, standard of care will not be impacted. | Other | Classical Music Arm |
Primary outcome
Post-Cystoscopy Anxiety Score
Time frame: Immediately after the procedure
Anxiety score is measured using the State Trait Anxiety Inventory (STAI). The STAI consists of two questionnaires that classifies a patient's anxiety into three groups on a scale of 20 to 80. The STAI includes two component questionnaires known as State Anxiety and Trait Anxiety. Trait Anxiety corresponds with stable individual anxiety measures while State Anxiety refers to anxiety that an individual is experiencing at a specific given moment at time. As described by the State-Trait Anxiety Inventory for Adults manual, people with higher Trait Anxiety measures may have elevated State Anxiety measures as compared to people with lower Trait Anxiety. In our study, Trait Anxiety will be controlled for, since differences in Trait Anxiety may confound State Anxiety measurements due to the individual being naturally more anxious due to unrelated reasons. A higher STAI anxiety score indicates higher anxiety.
Change in Anxiety Score from immediately before to immediately after cystoscopy (delta STAI)
Time frame: Change from immediately before the procedure to immediately after the procedure
The delta State Trait Anxiety Inventory (delta STAI) is a measure of the change in STAI anxiety score immediately after the cystoscopy minus STAI anxiety score immediately prior to the cystoscopy. The delta STAI ranges on a scale from negative 60 to positive 60. A positive delta STAI score indicates that there was a greater STAI anxiety score immediately after the procedure as compared to immediately before the procedure. A higher positive delta STAI score means a greater increase in anxiety as compared to a lower delta STAI score. A negative delta STAI score indicates that there was a lower STAI anxiety score immediately after the procedure as compared to immediately before the procedure. A more negative delta STAI score indicates a greater decrease in anxiety as compared to a less negative delta STAI score. A delta STAI score of 0 indicates that there was no change in STAI anxiety score from immediately before the procedure to immediately after the procedure.
Pelvic pain score
Time frame: Immediately after the procedure
Pelvic pain will be measured using a Visual Analog Scale (VAS). The VAS score is completed by the patient ranking their pain intensity on 10-cm lines and providing a range of scores from 0 to 100. This measure is then converted to a score of 10 (to 1 decimal eg. 8.2/10). For this study, VAS scales will be filled out by the patient immediately following their cystoscopy. A higher VAS score indicates greater self reported pelvic pain.
6 secondary outcomes
Pelvic discomfort score
Time frame: Immediately after the procedure
Patient satisfaction score
Time frame: Immediately after the procedure
Willingness to repeat cystoscopy score
Time frame: Immediately after the procedure
How pleasant patients from music intervention groups found the music
Time frame: Immediately after the procedure
How calming patients from music intervention groups found the music
Time frame: Immediately after the procedure
How much patients from music intervention groups found that music helped distract them from the cystoscopy procedure
Time frame: Immediately after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- 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.
Gavin M Langille, MD principal investigator
Horizon Health Network, Dalhousie University Department of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preferred Music Arm and Classical Music Arm in people with Flexible Cystoscopy, run by Horizon Health Network at 1 site in Canada.
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 8 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: status not confirmed, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gavin M Langille, MD (506-636-8818, Gavin.Langille@Dal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Cystoscopy Anxiety Score (time frame: Immediately after the procedure). 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?
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 14 Jul 2023.