4-7-8 Breathing TechniqueNCT07457086
The Effects of the 4-7-8 Breathing Technique on Sleep Quality, Pain, and Recovery Outcomes in Patients Undergoing Transurethral Resection of the Bladder
A study testing 4-7-8 breathing technique in people with 4-7-8 Breathing Technique, run by Tarsus University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine the effects of the 4-7-8 breathing technique on sleep quality, pain, and recovery quality in patients undergoing transurethral resection of the bladder (TUR-B). The population of the study will consist of patients who undergo TUR-B in the urology clinics of Tarsus State Hospital. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- 4-7-8 Breathing Technique
- What is being tested?
- 4-7-8 breathing technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2026to 20 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 years and older,
- Patients undergoing transurethral resection of the bladder (TUR-B),
- Patients who are conscious, oriented, and cooperative,
- Patients who provide written consent to participate in the study,
- Patients who stay in the hospital for at least one night postoperatively,
- Patients who speak and understand Turkish.
Who cannot join
- Patients who do not wish to participate or who withdraw from the study,
- Patients who develop complications during or after the surgical procedure,
- Patients who are followed in the intensive care unit postoperatively,
- Patients with chronic pain.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Tarsus University
Mersin, Turkey, 33400
Gamze Bozkul, 03246000033, gamze.bozkul@gmail.com
About this study
Official title: The Effects of the 4-7-8 Breathing Technique on Sleep Quality, Pain, and Recovery Outcomes in Patients Undergoing Transurethral Resection of the Bladder:A Randomized Controlled Trial
The aim of this study was to determine the effects of the 4-7-8 breathing technique on sleep quality, pain, and recovery quality in patients undergoing transurethral resection of the bladder (TUR-B). The population of the study will consist of patients who undergo TUR-B in the urology clinics of Tarsus State Hospital. In determining the sample size, the number of samples calculated based on the pain variable in reference studies was minimal; therefore, an effect size of 0.80, considered the upper limit, was taken as the basis. Using a power level of 90% and a two-tailed significance level (1-α), the calculation performed with G*Power (version 3.1) resulted in a minimum total sample size of 68 patients, with 34 patients in each group (study group = 34; control group = 34). Data in the study will be collected using the "Descriptive Characteristics Form," "Richard Campbell Sleep Questionnaire," "Quality of Recovery-15 Scale," and "Visual Analog Scale." When the researchers visit the patient, they will first provide the "Informed Consent Form" and then have the patient complete the "Descriptive Characteristics Form," "Richard Campbell Sleep Questionnaire," and "Quality of Recovery-15 Scale." The researcher will then learn from another researcher (MB), who will not be involved in data collection, which group the patient belongs to. Patients in the study group will be taught the 4-7-8 breathing technique by the researchers after their admission to the clinic. The patients will begin the application preoperatively and continue after returning to the clinic following the TUR-B procedure, starting from the 2nd hour after the effects of anesthesia have worn off. Initially, patients will be asked to perform the 4-7-8 breathing technique under the guidance of the researchers, and then continue the practice under researcher supervision. Subsequently, until discharge, patients will perform sets of four breaths every two hours. The control group will receive the routine postoperative procedures and care in the clinic. All patients will be assessed with the "Richard Campbell Sleep Questionnaire" and "Quality of Recovery-15 Scale" at the 24th hour postoperatively, and with the "Visual Analog Scale" at the 4th, 8th, 12th, and 24th postoperative hours.
Read the detailed description
The aim of this study was to determine the effects of the 4-7-8 breathing technique on sleep quality, pain, and recovery quality in patients undergoing transurethral resection of the bladder (TUR-B). The population of the study will consist of patients who undergo TUR-B in the urology clinics of Tarsus State Hospital. In determining the sample size, the number of samples calculated based on the pain variable in reference studies was minimal; therefore, an effect size of 0.80, considered the upper limit, was taken as the basis. Using a power level of 90% and a two-tailed significance level (1-α), the calculation performed with G*Power (version 3.1) resulted in a minimum total sample size of 68 patients, with 34 patients in each group (study group = 34; control group = 34).
Data in the study will be collected using the "Descriptive Characteristics Form," "Richard Campbell Sleep Questionnaire," "Quality of Recovery-15 Scale," and "Visual Analog Scale." When the researchers visit the patient, they will first provide the "Informed Consent Form" and then have the patient complete the "Descriptive Characteristics Form," "Richard Campbell Sleep Questionnaire," and "Quality of Recovery-15 Scale." The researcher will then learn from another researcher (MB), who will not be involved in data collection, which group the patient belongs to. Patients in the study group will be taught the 4-7-8 breathing technique by the researchers after their admission to the clinic. The patients will begin the application preoperatively and continue after returning to the clinic following the TUR-B procedure, starting from the 2nd hour after the effects of anesthesia have worn off. Initially, patients will be asked to perform the 4-7-8 breathing technique under the guidance of the researchers, and then continue the practice under researcher supervision. Subsequently, until discharge, patients will perform sets of four breaths every two hours. The control group will receive the routine postoperative procedures and care in the clinic. All patients will be assessed with the "Richard Campbell Sleep Questionnaire" and "Quality of Recovery-15 Scale" at the 24th hour postoperatively, and with the "Visual Analog Scale" at the 4th, 8th, 12th, and 24th postoperative hours.The data will be analyzed using a computer. Descriptive characteristics of the patients will be summarized as mean ± standard deviation, median (minimum-maximum), percentage, and frequency values. Qualitative data will be categorized and converted into quantitative data, and presented as percentages and frequency distributions. After examining the normality of the data distribution, the independent samples t-test will be used to compare continuous variables that show a normal distribution between two independent groups. For continuous variables that do not follow a normal distribution, group comparisons will be performed using the Mann-Whitney U test. A p-value of <0.05 will be considered statistically significant, with a 95% confidence interval.
- Conditions
- 4-7-8 Breathing Technique
- Being tested
- 4-7-8 breathing technique
- Keywords
- Sleep Quality, Pain, Nursing, Quality of Recovery
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-7-8 breathing techniqueOther
Patients in the study group will be taught the 4-7-8 breathing technique by the researchers after their admission to the clinic. The patients will begin the application preoperatively and continue after returning to the clinic following the TUR-B procedure, starting from the 2nd hour after the effects of anesthesia have worn off. Initially, patients will be asked to perform the 4-7-8 breathing technique under the guidance of the researchers, and then continue the practice under researcher supervision. Subsequently, until discharge, patients will perform sets of four breaths every two hours.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: 4-7-8 breathing exercise group | Experimental | Patients in the study group will be taught the 4-7-8 breathing technique by the researchers after their admission to the clinic. The patients will begin the application preoperatively and continue after returning to the clinic following the TUR-B procedure, starting from the 2nd hour after the effects of anesthesia have worn off. Initially, patients will be asked to perform the 4-7-8 breathing technique under the guidance of the researchers, and then continue the practice under researcher supervision. Subsequently, until discharge, patients will perform sets of four breaths every two hours. Receives: Other: 4-7-8 breathing technique |
| Control group | No intervention | The control group will receive the routine postoperative procedures and care in the clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep
Richard Campbell Sleep Questionnaire: This questionnaire is designed to assess various dimensions of an individual's nocturnal sleep, including sleep depth, sleep latency, number of awakenings during the night, duration of wakefulness after nocturnal awakenings, overall sleep quality, and environmental noise level. T. Each item is evaluated using a visual analog scale ranging from 0 to 100. When calculating the total score, only the first five items are considered, while the sixth item, which assesses environmental noise, is excluded from the evaluation. Scores between 0 and 25 indicate very poor sleep, whereas scores between 76 and 100 indicate very good sleep. Higher scores are interpreted as reflecting better sleep quality.
Measured: 6 months
Quality of Recovery
Quality of Recovery-15 (QoR-15) Scale: Aimed at assessing recovery quality and overall well-being, this instrument uses a visual analog scale for evaluation. The scale consists of 15 items and includes two subdimensions. Each item is marked on a horizontal line 10 cm in length, with each centimeter representing 1 point, resulting in item scores ranging from 0 to 10. During evaluation, positive statements are scored such that 0 corresponds to "never" and 10 to "always," while negative statements are reverse-scored, with 0 representing "always" and 10 representing "never." The total score of the scale ranges from 0 to 150, with higher scores indicating better recovery quality. The first subdimension assesses the patient's subjective feelings and emotions over the past 24 hour
Measured: 6 months
Pain Level
This scale allows patients to evaluate their level of pain on a line ranging from 0 (no pain) to 10 (extremely severe pain). It will be used to assess the intensity of pain experienced by the patients.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start20 Mar 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion20 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 4-7-8 Breathing TechniqueStudies 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 randomized controlled experimental study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze BOZKUL, Tarsus University
- Investigators
- Gamze Bozkul, Principal investigator, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457086
- Sponsor's protocol ID
- TU-BOZKUL-016
- Status last verified
- Sep 2026
- First submitted
- 3 Mar 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aktas GK, Ilgin VE. The Effect of Deep Breathing Exercise and 4-7-8 Breathing Techniques Applied to Patients After Bariatric Surgery on Anxiety and Quality of Life. Obes Surg. 2023 Mar;33(3):920-929. doi: 10.1007/s11695-022-06405-1. Epub 2022 Dec 8.
PubMed 364801017. Eskici İlgin, V., & Yayla, A. (2023). Effect of the 4-7-8 breathing technique on pain level and sleep quality of patients after laparoscopic bariatric surgery: A randomized controlled study. Bariatric Surgical Practice and Patient Care, 18(4), 225-232. https://doi.org/10.1089/bari.2022.0044
Eskimez Z, Keskin A, Kurt E, Ozbarlas HS, Tekin M, Kundakci B. 4-7-8 Breathing Techniques Make It Possible to Reduce Pain Associated With Total Knee Arthroplasty: A New Technique in Respiratory Exercises. J Perianesth Nurs. 2026 Feb;41(1):48-53. doi: 10.1016/j.jopan.2025.04.009. Epub 2025 Jul 30.
PubMed 407423422. Özlü, Z. K. ve Özer, N. (2015). Richard-campbell uyku ölçeği geçerlilik ve güvenilirlik çalışması. Journal of Turkish Sleep Medicine, 2: 29-32.
Kara U, Simsek F, Kamburoglu H, Ozhan MO, Alakus U, Ince ME, Eksert S, Ozkan G, Eskin MB, Senkal S. Linguistic validation of a widely used recovery score: quality of recovery-15 (QoR-15). Turk J Med Sci. 2022 Apr;52(2):427-435. doi: 10.55730/1300-0144.5330. Epub 2022 Apr 14.
PubMed 36161615
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the 4-7-8 Breathing Technique on Sleep Quality, Pain, and Recovery Outcomes in Patients Undergoing Transurethral Resection of the Bladder:A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07457086
- Acronym / sponsor ID
- TU-BOZKUL-016
- Conditions
- 4-7-8 Breathing Technique
- Keywords
- Sleep Quality, Pain, Nursing, Quality of Recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 20 Aug 2027 (estimated)
- First posted
- 9 Mar 2026 (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 effects of the 4-7-8 breathing technique on sleep quality, pain, and recovery quality in patients undergoing transurethral resection of the bladder (TUR-B). The population of the study will consist of patients who undergo TUR-B in the urology clinics of Tarsus State Hospital. In determining the sample size, the number of samples calculated based on the pain variable in reference studies was minimal; therefore, an effect size of 0.80, considered the upper limit, was taken as the basis. Using a power level of 90% and a two-tailed significance level (1-α), the calculation performed with G*Power (version 3.1) resulted in a minimum total sample size of 68 patients, with 34 patients in each group (study group = 34; control group = 34). Data in the study will be collected using the "Descriptive Characteristics Form," "Richard Campbell Sleep Questionnaire," "Quality of Recovery-15 Scale," and "Visual Analog Scale." When the researchers visit the patient, they will first provide the "Informed Consent Form" and then have the patient complete the "Descriptive Characteristics Form," "Richard Campbell Sleep Questionnaire," and "Quality of Recovery-15 Scale." The researcher will then learn from another researcher (MB), who will not be involved in data collection, which group the patient belongs to. Patients in the study group will be taught the 4-7-8 breathing technique by the researchers after their admission to the clinic. The patients will begin the application preoperatively and continue after returning to the clinic following the TUR-B procedure, starting from the 2nd hour after the effects of anesthesia have worn off. Initially, patients will be asked to perform the 4-7-8 breathing technique under the guidance of the researchers, and then continue the practice under researcher supervision. Subsequently, until discharge, patients will perform sets of four breaths every two hours. The control group will receive the routine postoperative procedures and care in the clinic. All patients will be assessed with the "Richard Campbell Sleep Questionnaire" and "Quality of Recovery-15 Scale" at the 24th hour postoperatively, and with the "Visual Analog Scale" at the 4th, 8th, 12th, and 24th postoperative hours.
Detailed description
The aim of this study was to determine the effects of the 4-7-8 breathing technique on sleep quality, pain, and recovery quality in patients undergoing transurethral resection of the bladder (TUR-B). The population of the study will consist of patients who undergo TUR-B in the urology clinics of Tarsus State Hospital. In determining the sample size, the number of samples calculated based on the pain variable in reference studies was minimal; therefore, an effect size of 0.80, considered the upper limit, was taken as the basis. Using a power level of 90% and a two-tailed significance level (1-α), the calculation performed with G*Power (version 3.1) resulted in a minimum total sample size of 68 patients, with 34 patients in each group (study group = 34; control group = 34).
Data in the study will be collected using the "Descriptive Characteristics Form," "Richard Campbell Sleep Questionnaire," "Quality of Recovery-15 Scale," and "Visual Analog Scale." When the researchers visit the patient, they will first provide the "Informed Consent Form" and then have the patient complete the "Descriptive Characteristics Form," "Richard Campbell Sleep Questionnaire," and "Quality of Recovery-15 Scale." The researcher will then learn from another researcher (MB), who will not be involved in data collection, which group the patient belongs to. Patients in the study group will be taught the 4-7-8 breathing technique by the researchers after their admission to the clinic. The patients will begin the application preoperatively and continue after returning to the clinic following the TUR-B procedure, starting from the 2nd hour after the effects of anesthesia have worn off. Initially, patients will be asked to perform the 4-7-8 breathing technique under the guidance of the researchers, and then continue the practice under researcher supervision. Subsequently, until discharge, patients will perform sets of four breaths every two hours. The control group will receive the routine postoperative procedures and care in the clinic. All patients will be assessed with the "Richard Campbell Sleep Questionnaire" and "Quality of Recovery-15 Scale" at the 24th hour postoperatively, and with the "Visual Analog Scale" at the 4th, 8th, 12th, and 24th postoperative hours.The data will be analyzed using a computer. Descriptive characteristics of the patients will be summarized as mean ± standard deviation, median (minimum-maximum), percentage, and frequency values. Qualitative data will be categorized and converted into quantitative data, and presented as percentages and frequency distributions. After examining the normality of the data distribution, the independent samples t-test will be used to compare continuous variables that show a normal distribution between two independent groups. For continuous variables that do not follow a normal distribution, group comparisons will be performed using the Mann-Whitney U test. A p-value of <0.05 will be considered statistically significant, with a 95% confidence interval.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study was planned as a randomized controlled experimental study
| Arm | Type | Receives |
|---|---|---|
| Experimental: 4-7-8 breathing exercise group | Experimental | Other: 4-7-8 breathing techniquePatients in the study group will be taught the 4-7-8 breathing technique by the researchers after their admission to the clinic. The patients will begin the application preoperatively and continue after returning to the clinic following the TUR-B procedure, starting from the 2nd hour after the effects of anesthesia have worn off. Initially, patients will be asked to perform the 4-7-8 breathing technique under the guidance of the researchers, and then continue the practice under researcher supervision. Subsequently, until discharge, patients will perform sets of four breaths every two hours. |
| Control group | No intervention | –The control group will receive the routine postoperative procedures and care in the clinic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 18 years and older,
- Patients undergoing transurethral resection of the bladder (TUR-B),
- Patients who are conscious, oriented, and cooperative,
- Patients who provide written consent to participate in the study,
- Patients who stay in the hospital for at least one night postoperatively,
Key exclusion criteria (4 listed)
- Patients who do not wish to participate or who withdraw from the study,
- Patients who develop complications during or after the surgical procedure,
- Patients who are followed in the intensive care unit postoperatively,
- Patients with chronic pain.
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 |
|---|---|---|
| 4-7-8 breathing techniquePatients in the study group will be taught the 4-7-8 breathing technique by the researchers after their admission to the clinic. The patients will begin the application preoperatively and continue after returning to the clinic following the TUR-B procedure, starting from the 2nd hour after the effects of anesthesia have worn off. Initially, patients will be asked to perform the 4-7-8 breathing technique under the guidance of the researchers, and then continue the practice under researcher supervision. Subsequently, until discharge, patients will perform sets of four breaths every two hours. | Other | Experimental: 4-7-8 breathing exercise group |
Primary outcome
Sleep
Time frame: 6 months
Richard Campbell Sleep Questionnaire: This questionnaire is designed to assess various dimensions of an individual's nocturnal sleep, including sleep depth, sleep latency, number of awakenings during the night, duration of wakefulness after nocturnal awakenings, overall sleep quality, and environmental noise level. T. Each item is evaluated using a visual analog scale ranging from 0 to 100. When calculating the total score, only the first five items are considered, while the sixth item, which assesses environmental noise, is excluded from the evaluation. Scores between 0 and 25 indicate very poor sleep, whereas scores between 76 and 100 indicate very good sleep. Higher scores are interpreted as reflecting better sleep quality.
Quality of Recovery
Time frame: 6 months
Quality of Recovery-15 (QoR-15) Scale: Aimed at assessing recovery quality and overall well-being, this instrument uses a visual analog scale for evaluation. The scale consists of 15 items and includes two subdimensions. Each item is marked on a horizontal line 10 cm in length, with each centimeter representing 1 point, resulting in item scores ranging from 0 to 10. During evaluation, positive statements are scored such that 0 corresponds to "never" and 10 to "always," while negative statements are reverse-scored, with 0 representing "always" and 10 representing "never." The total score of the scale ranges from 0 to 150, with higher scores indicating better recovery quality. The first subdimension assesses the patient's subjective feelings and emotions over the past 24 hour
Pain Level
Time frame: 6 months
This scale allows patients to evaluate their level of pain on a line ranging from 0 (no pain) to 10 (extremely severe pain). It will be used to assess the intensity of pain experienced by the patients.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Background: PubMed 36480101Aktas GK, Ilgin VE. The Effect of Deep Breathing Exercise and 4-7-8 Breathing Techniques Applied to Patients After Bariatric Surgery on Anxiety and Quality of Life. Obes Surg. 2023 Mar;33(3):920-929. doi: 10.1007/s11695-022-06405-1. Epub 2022 Dec 8.
- Background7. Eskici İlgin, V., & Yayla, A. (2023). Effect of the 4-7-8 breathing technique on pain level and sleep quality of patients after laparoscopic bariatric surgery: A randomized controlled study. Bariatric Surgical Practice and Patient Care, 18(4), 225-232. https://doi.org/10.1089/bari.2022.0044
- Background: PubMed 40742342Eskimez Z, Keskin A, Kurt E, Ozbarlas HS, Tekin M, Kundakci B. 4-7-8 Breathing Techniques Make It Possible to Reduce Pain Associated With Total Knee Arthroplasty: A New Technique in Respiratory Exercises. J Perianesth Nurs. 2026 Feb;41(1):48-53. doi: 10.1016/j.jopan.2025.04.009. Epub 2025 Jul 30.
- Background2. Özlü, Z. K. ve Özer, N. (2015). Richard-campbell uyku ölçeği geçerlilik ve güvenilirlik çalışması. Journal of Turkish Sleep Medicine, 2: 29-32.
- Results publication: PubMed 36161615Kara U, Simsek F, Kamburoglu H, Ozhan MO, Alakus U, Ince ME, Eksert S, Ozkan G, Eskin MB, Senkal S. Linguistic validation of a widely used recovery score: quality of recovery-15 (QoR-15). Turk J Med Sci. 2022 Apr;52(2):427-435. doi: 10.55730/1300-0144.5330. Epub 2022 Apr 14.
- 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.
Gamze Bozkul principal investigator
Tarsus 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 4-7-8 breathing technique in people with 4-7-8 Breathing Technique, 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 6 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: looking for participants now, as of the sponsor's last update on 2 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GAMZE Bozkul, Dr (+903246000033, gamze.bozkul@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep (time frame: 6 months). 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?
On the ClinicalTrials.gov record for NCT07457086, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.