Interstitial CystitisNCT05155384
Biopsychosocial and Conventional Approach in Bladder Pain Syndrome
A study testing Pain Neuroscience Education, Relaxation exercises and Cognition target exercise in people with Interstitial Cystitis and Bladder Pain Syndrome, run by Hacettepe University at 3 sites in Turkey (Türkiye).
Trial summary
The aim of the present study is to compare the effects of biopsychosocial and conventional approach on symptom severity, pain parameters (pain intensity and pain cognitions), disability, psychological distress and quality of life in patients who are suffering from bladder pain syndrome/interstitial cystitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Cystitis, Bladder Pain Syndrome
- What is being tested?
- Pain Neuroscience Education, Relaxation exercises and Cognition target exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 12 Nov 2021to 15 Oct 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Bladder Pain Syndrome/Interstitial Cystitis
- with chronic symptoms (more than 6 months)
- Bladder pain severity in the last week should be at least 3/10 according to the Visual Analogue Scale (VAS)
- Stable medication schedule
- Individuals over the age of 18 (individuals over 65 years of age with a Mini Mental Test score ≥ 24) voluntarily to participate in the study will be included.
Who cannot join
- Acute disease state (with ongoing urinary tract infection, active vaginitis, active Herpes infection)
- Stones in the bladder, ureter, or urethra in the last 3 months
- Having an ulcer appearance on cystoscopy
- For women: during pregnancy and/or breastfeeding
- Previous history of urological and/or pelvic malignancy
- Congenital anomaly of the upper and/or lower urinary tract
Show all 10Show fewer
- who have started a new drug treatment in the last 3 months, or undergoing implantation operation of neuromodulation devices
- Diagnosed with opioid dependence
- Neurogenic bladder dysfunction or concomitant neurologic conditions
- Not cooperating with assessment and/or treatment, and illiterate individuals
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites, 3 recruiting
- Recruiting
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Ankara, 06100
Ceren Gursen, Phd, +905380644120, cerengursen@yahoo.com
Naside Mangir Bolat, PhD
- Recruiting
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Ankara, 06100
Ceren Gursen, PhD, +905380644120, cerengursen@yahoo.com
- Recruiting
Hacettepe University
Ankara, 06100
Ceren Gursen, PhD, +905380644120, cerengursen@yahoo.com
About this study
Official title: Comparison of Biopsychosocial and Conventional Approach in the Treatment of Bladder Pain Syndrome/Interstitial Cystitis
The aim of the present study is to compare the effects of biopsychosocial and conventional approach on symptom severity, pain parameters (pain intensity and pain cognitions), disability, psychological distress and quality of life in patients who are suffering from bladder pain syndrome/interstitial cystitis. The study is designed as a randomized clinical trial including two parallel arms.
Individuals who meet the inclusion criteria and agree to participate will be randomly assigned into one of the two research arms: biopsychosocial approach group or conventional approach group. A biopsychosocial approach, which is a holistic approach that includes pain neuroscience education, relaxation training and cognitive exercises, will be applied to the patients in the first research arm for the treatment of chronic pain symptoms. For the patients in the second research arm, a conventional approach including pelvic floor stretching exercises and Transcutaneous Electrical Nerve Stimulation (TENS) will be applied for the treatment of chronic pain complaints. Treatments will be lasted for a total of six weeks, with two sessions per week. Participants will be evaluated at the baseline (before treatments) and at the end of the 6th week (after treatments). In the evaluations, information about the demographic and physical characteristics, medical and surgical background, medications and lifestyle characteristics (water, tea, coffee, alcohol, cigarette consumption, the presence constipation and physical activity level) of the individuals will be recorded. For primary or secondary outcome measures, Interstitial Cystitis Symptom and Problem Index, Visual Analog Scale, Pain Catastrophizing Scale, Pain Self-Efficacy Questionnaire, 3-day voiding diary, Pain Disability Index, Hospital Anxiety and Depression Scale, and Short Form-36 will be used. The present study is planned to be carried out with a total of 60 individuals, 30 for each study group based on a sample size analysis.
After reaching required sample for the present study, in patients with bladder pain syndrome/interstitial cystitis, the effects of biopsychosocial and conventional approach on symptom and problem severity, pain parameters, disability, psychological status and quality of life will be analyzed using (2*2) two-way ANOVA.
- Conditions
- Interstitial Cystitis, Bladder Pain Syndrome
- Being tested
- Pain Neuroscience Education, Relaxation exercises, Cognition target exercise, Pelvic floor stretching exercises, Transcutaneous electrical nerve stimulation
- Keywords
- chronic pain, pain neuroscience education, Bladder Pain Syndrome, Interstitial Cystitis
- Medical subject headings
- Cystitis, Interstitial, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Neuroscience EducationOther
main topics of pain neuroscience education; neurophysiology of the nervous system, protective mechanism of pain, acute pain formation and chronic pain, factors that increase/reduce pain, central sensitization mechanism, neuroplasticity and treatment strategies in chronic pain.
Relaxation exercisesOther
Relaxation exercises are a training based on deep relaxation techniques and visual imagery. Relaxation exercises will be applied at the end of the training sessions.
Cognition target exerciseOther
Cognition target exercises are a time-based approach that is not symptom-conditioned (not based on fatigue or pain). It includes functional and dynamic exercises.
Pelvic floor stretching exercisesOther
Pelvic floor stretching exercises; consists of stretching exercises involving the pelvic floor muscles and surrounding group muscles (such as piriformis, hamstring, adductor group muscles and lumbar extensors).
Transcutaneous electrical nerve stimulationDevice
It will be used with superficial electrodes attached to the suprapubic region of the patients for 20 minutes in each session.
| Study group | Role | What they receive |
|---|---|---|
| biopsychosocial model-based treatment | Experimental | Biopsychosocial model-based management will be applied including pain neuroscience education, functional exercises, and relaxation training. Receives: Other: Pain Neuroscience Education; Other: Relaxation exercises; Other: Cognition target exercise |
| Conventional physiotherapy | Active comparator | Conventional physiotherapy will be applied including standard exercises and electrical stimulation. Receives: Other: Pelvic floor stretching exercises; Device: Transcutaneous electrical nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of symptoms
The Interstitial Cystitis Symptom and Problem Index will be used to assess the severity of symptoms. This scale consists of two separate parts as symptom and problem index, both of which are four questions. Participants will be asked to fill in both parts.
Measured: change in severity of symptoms from baseline up to end of 6th week
Secondary outcomes (6)
severity of pain
Pain severity will be evaluated with the Visual Analogue Scale (VAS). Considering the last week, the patients will be asked to mark the severity of pain on a 10-centimeter (cm) straight line, with the starting end as "no pain" and the ending end as "unbearable pain". It will be calculated in cm by measuring the starting tip and the part marked by the patient.
Measured: change in severity of pain from baseline up to end of 6th week
Pain cognitions
Pain Catastrophizing Scale and Pain Self-Efficacy Questionnaire will be used to assess individuals' cognitions about pain (catastrophizing and self-efficacy).
Measured: change in pain cognitions from baseline up to end of 6th week
urinary symptoms
A 3-day voiding diary will be used to evaluate Urinary Symptoms. On this chart, they are asked to record the time they urinate, the amount of urine, the presence of urinary incontinence, the amount and type of fluid consumed.
Measured: change in urinary symptoms from baseline up to end of 6th week
severity of disability
The Pain Disability Index will be used to question the impact of individuals' daily life due to their pain and the resulting disability.
Measured: change in severity of disability from baseline up to end of 6th week
psychological distress
The Hospital Anxiety and Depression Scale will be used to evaluate the psychological distress of individuals. The questionnaire has two sub-dimensions, depression and anxiety.
Measured: change in psychological distress from baseline up to end of 6th week
quality of life of the patients
Quality of Life will be assessed using the SF-36 scale. Short Form-36 will be used for evaluations. This questionnaire consists of eight different sub-parameters (physical function, physical role difficulty, general health status, pain status, energy/fatigue, social function, emotional role difficulty, and emotional well-being).
Measured: change in quality of life from baseline up to end of 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start12 Nov 2021
- Primary completion15 Oct 2022 (estimated)
- Study completion15 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceren Gursen, Hacettepe University
- Investigators
- Ceren Gürşen, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155384
- Sponsor's protocol ID
- KA- 21109
- Status last verified
- Dec 2021
- First submitted
- 10 Dec 2021
- Last updated
- 3 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
O'Leary MP, Sant GR, Fowler FJ Jr, Whitmore KE, Spolarich-Kroll J. The interstitial cystitis symptom index and problem index. Urology. 1997 May;49(5A Suppl):58-63. doi: 10.1016/s0090-4295(99)80333-1.
PubMed 9146003Von Korff M, Jensen MP, Karoly P. Assessing global pain severity by self-report in clinical and health services research. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3140-51. doi: 10.1097/00007632-200012150-00009. No abstract available.
PubMed 11124730Suren M, Okan I, Gokbakan AM, Kaya Z, Erkorkmaz U, Arici S, Karaman S, Kahveci M. Factors associated with the pain catastrophizing scale and validation in a sample of the Turkish population. Turk J Med Sci. 2014;44(1):104-8. doi: 10.3906/sag-1206-67.
PubMed 25558568Nicholas MK. The pain self-efficacy questionnaire: Taking pain into account. Eur J Pain. 2007 Feb;11(2):153-63. doi: 10.1016/j.ejpain.2005.12.008. Epub 2006 Jan 30.
PubMed 16446108Pollard CA. Preliminary validity study of the pain disability index. Percept Mot Skills. 1984 Dec;59(3):974. doi: 10.2466/pms.1984.59.3.974. No abstract available.
PubMed 6240632Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820Ware JE Jr. SF-36 health survey update. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3130-9. doi: 10.1097/00007632-200012150-00008. No abstract available.
PubMed 11124729Fitzgerald MP, Anderson RU, Potts J, Payne CK, Peters KM, Clemens JQ, Kotarinos R, Fraser L, Cosby A, Fortman C, Neville C, Badillo S, Odabachian L, Sanfield A, O'Dougherty B, Halle-Podell R, Cen L, Chuai S, Landis JR, Mickelberg K, Barrell T, Kusek JW, Nyberg LM; Urological Pelvic Pain Collaborative Research Network. Randomized multicenter feasibility trial of myofascial physical therapy for the treatment of urological chronic pelvic pain syndromes. J Urol. 2013 Jan;189(1 Suppl):S75-85. doi: 10.1016/j.juro.2012.11.018.
PubMed 23234638Yazici Ilhan H, Ozgul S, Akbayrak T, Mangir N, Guloren G, Gursen C. Effects of functional versus conventional Physiotherapy-Based pain management on symptoms, psychological outcomes, and quality of life in women with Bladder Pain Syndrome: A Randomized Controlled Trial. Physiother Theory Pract. 2026 Aug 16:1-15. doi: 10.1080/09593985.2026.2715733. Online ahead of print.
PubMed 42604487
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Biopsychosocial and Conventional Approach in the Treatment of Bladder Pain Syndrome/Interstitial Cystitis
- ClinicalTrials.gov ID
- NCT05155384
- Acronym / sponsor ID
- KA- 21109
- Conditions
- Interstitial Cystitis, Bladder Pain Syndrome
- Keywords
- chronic pain, pain neuroscience education, Bladder Pain Syndrome, Interstitial Cystitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 12 Nov 2021 (actual)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 15 Oct 2022 (estimated)
- First posted
- 13 Dec 2021 (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 the present study is to compare the effects of biopsychosocial and conventional approach on symptom severity, pain parameters (pain intensity and pain cognitions), disability, psychological distress and quality of life in patients who are suffering from bladder pain syndrome/interstitial cystitis. The study is designed as a randomized clinical trial including two parallel arms.
Individuals who meet the inclusion criteria and agree to participate will be randomly assigned into one of the two research arms: biopsychosocial approach group or conventional approach group. A biopsychosocial approach, which is a holistic approach that includes pain neuroscience education, relaxation training and cognitive exercises, will be applied to the patients in the first research arm for the treatment of chronic pain symptoms. For the patients in the second research arm, a conventional approach including pelvic floor stretching exercises and Transcutaneous Electrical Nerve Stimulation (TENS) will be applied for the treatment of chronic pain complaints. Treatments will be lasted for a total of six weeks, with two sessions per week. Participants will be evaluated at the baseline (before treatments) and at the end of the 6th week (after treatments). In the evaluations, information about the demographic and physical characteristics, medical and surgical background, medications and lifestyle characteristics (water, tea, coffee, alcohol, cigarette consumption, the presence constipation and physical activity level) of the individuals will be recorded. For primary or secondary outcome measures, Interstitial Cystitis Symptom and Problem Index, Visual Analog Scale, Pain Catastrophizing Scale, Pain Self-Efficacy Questionnaire, 3-day voiding diary, Pain Disability Index, Hospital Anxiety and Depression Scale, and Short Form-36 will be used. The present study is planned to be carried out with a total of 60 individuals, 30 for each study group based on a sample size analysis.
After reaching required sample for the present study, in patients with bladder pain syndrome/interstitial cystitis, the effects of biopsychosocial and conventional approach on symptom and problem severity, pain parameters, disability, psychological status and quality of life will be analyzed using (2*2) two-way ANOVA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| biopsychosocial model-based treatment | Experimental | Other: Pain Neuroscience Education, Other: Relaxation exercises, Other: Cognition target exerciseBiopsychosocial model-based management will be applied including pain neuroscience education, functional exercises, and relaxation training. |
| Conventional physiotherapy | Active comparator | Other: Pelvic floor stretching exercises, Device: Transcutaneous electrical nerve stimulationConventional physiotherapy will be applied including standard exercises and electrical stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with Bladder Pain Syndrome/Interstitial Cystitis
- with chronic symptoms (more than 6 months)
- Bladder pain severity in the last week should be at least 3/10 according to the Visual Analogue Scale (VAS)
- Stable medication schedule
- Individuals over the age of 18 (individuals over 65 years of age with a Mini Mental Test score ≥ 24) voluntarily to participate in the study will be included.
Key exclusion criteria (10 listed)
- Acute disease state (with ongoing urinary tract infection, active vaginitis, active Herpes infection)
- Stones in the bladder, ureter, or urethra in the last 3 months
- Having an ulcer appearance on cystoscopy
- For women: during pregnancy and/or breastfeeding
- Previous history of urological and/or pelvic malignancy
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 |
|---|---|---|
| Pain Neuroscience Educationmain topics of pain neuroscience education; neurophysiology of the nervous system, protective mechanism of pain, acute pain formation and chronic pain, factors that increase/reduce pain, central sensitization mechanism, neuroplasticity and treatment strategies in chronic pain. | Other | biopsychosocial model-based treatment |
| Relaxation exercisesRelaxation exercises are a training based on deep relaxation techniques and visual imagery. Relaxation exercises will be applied at the end of the training sessions. | Other | biopsychosocial model-based treatment |
| Cognition target exerciseCognition target exercises are a time-based approach that is not symptom-conditioned (not based on fatigue or pain). It includes functional and dynamic exercises. | Other | biopsychosocial model-based treatment |
| Pelvic floor stretching exercisesPelvic floor stretching exercises; consists of stretching exercises involving the pelvic floor muscles and surrounding group muscles (such as piriformis, hamstring, adductor group muscles and lumbar extensors). | Other | Conventional physiotherapy |
| Transcutaneous electrical nerve stimulationIt will be used with superficial electrodes attached to the suprapubic region of the patients for 20 minutes in each session. | Device | Conventional physiotherapy |
Primary outcome
severity of symptoms
Time frame: change in severity of symptoms from baseline up to end of 6th week
The Interstitial Cystitis Symptom and Problem Index will be used to assess the severity of symptoms. This scale consists of two separate parts as symptom and problem index, both of which are four questions. Participants will be asked to fill in both parts.
6 secondary outcomes
severity of pain
Time frame: change in severity of pain from baseline up to end of 6th week
Pain cognitions
Time frame: change in pain cognitions from baseline up to end of 6th week
urinary symptoms
Time frame: change in urinary symptoms from baseline up to end of 6th week
severity of disability
Time frame: change in severity of disability from baseline up to end of 6th week
psychological distress
Time frame: change in psychological distress from baseline up to end of 6th week
quality of life of the patients
Time frame: change in quality of life from baseline up to end of 6th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Background: PubMed 9146003O'Leary MP, Sant GR, Fowler FJ Jr, Whitmore KE, Spolarich-Kroll J. The interstitial cystitis symptom index and problem index. Urology. 1997 May;49(5A Suppl):58-63. doi: 10.1016/s0090-4295(99)80333-1.
- Background: PubMed 11124730Von Korff M, Jensen MP, Karoly P. Assessing global pain severity by self-report in clinical and health services research. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3140-51. doi: 10.1097/00007632-200012150-00009. No abstract available.
- Background: PubMed 25558568Suren M, Okan I, Gokbakan AM, Kaya Z, Erkorkmaz U, Arici S, Karaman S, Kahveci M. Factors associated with the pain catastrophizing scale and validation in a sample of the Turkish population. Turk J Med Sci. 2014;44(1):104-8. doi: 10.3906/sag-1206-67.
- Background: PubMed 16446108Nicholas MK. The pain self-efficacy questionnaire: Taking pain into account. Eur J Pain. 2007 Feb;11(2):153-63. doi: 10.1016/j.ejpain.2005.12.008. Epub 2006 Jan 30.
- Background: PubMed 6240632Pollard CA. Preliminary validity study of the pain disability index. Percept Mot Skills. 1984 Dec;59(3):974. doi: 10.2466/pms.1984.59.3.974. No abstract available.
- Background: PubMed 6880820Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- Background: PubMed 11124729Ware JE Jr. SF-36 health survey update. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3130-9. doi: 10.1097/00007632-200012150-00008. No abstract available.
- Background: PubMed 23234638Fitzgerald MP, Anderson RU, Potts J, Payne CK, Peters KM, Clemens JQ, Kotarinos R, Fraser L, Cosby A, Fortman C, Neville C, Badillo S, Odabachian L, Sanfield A, O'Dougherty B, Halle-Podell R, Cen L, Chuai S, Landis JR, Mickelberg K, Barrell T, Kusek JW, Nyberg LM; Urological Pelvic Pain Collaborative Research Network. Randomized multicenter feasibility trial of myofascial physical therapy for the treatment of urological chronic pelvic pain syndromes. J Urol. 2013 Jan;189(1 Suppl):S75-85. doi: 10.1016/j.juro.2012.11.018.
- Derived from this study: PubMed 42604487Yazici Ilhan H, Ozgul S, Akbayrak T, Mangir N, Guloren G, Gursen C. Effects of functional versus conventional Physiotherapy-Based pain management on symptoms, psychological outcomes, and quality of life in women with Bladder Pain Syndrome: A Randomized Controlled Trial. Physiother Theory Pract. 2026 Aug 16:1-15. doi: 10.1080/09593985.2026.2715733. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Interstitial Cystitis
Active, not recruiting
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
Bladder Cancer, Prostate Cancer
Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
Recruiting
Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome
Bladder Pain Syndrome, Painful Bladder 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.
Ceren Gürşen, PhD principal investigator
Hacettepe University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Neuroscience Education, Relaxation exercises and Cognition target exercise in people with Interstitial Cystitis and Bladder Pain Syndrome, run by Hacettepe University at 3 sites 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 5 inclusion and 10 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 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ceren Gursen, PhD (+905380644120, cerengursen@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severity of symptoms (time frame: change in severity of symptoms from baseline up to end of 6th week). 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 NCT05155384, which also lists 9 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 Jan 2022.