HemodialysisNCT06519136
The Effect of Second Level Reiki on Pain Severity and Quality of Life in Patients Receiving Hemodialysis Treatment
A study testing Distance Reiki in people with Hemodialysis, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: The aim of this study is to determine the effect of 20-minute second-level Reiki application for 4 consecutive days on pain intensity and quality of life in patients receiving hemodialysis (HD) treatment and It is a comparison of the follow-up results of the first level Reiki applied within the scope of the… Read more about this study
- Who is it for?
- Ages 28 to 84 years
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Distance Reiki
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 14 Dec 2024
- 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 28 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who volunteered to participate in the research and received first level Reiki within the scope of the study titled "The effect of Reiki application on pain severity and quality of life in patients receiving hemodialysis treatment",
- In patients over 65 years of age, patients with a Standardized Mini Mental Test (SMMT) score of 24 points and above will be included in the sample.
Who cannot join
- Those who do not volunteer to participate in the research,
- Deceased,
- Changing the treatment center,
- Starting to receive peritoneal dialysis treatment or having renal transplantation,
- Using another complementary integrative therapy application,
- In patients over 65 years of age, patients with an SMMT value below 24 will not be included in the sample.
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
Sultan Çeçen
Çorum, 19030
About this study
Official title: The Effect of Reiki Therapy on Pain Severity and Quality of Life in Patients Undergoing Hemodialysis: A Follow-Up and Evaluation Study of First-Level Reiki Versus Second-Level Reiki Application
Purpose: The aim of this study is to determine the effect of 20-minute second-level Reiki application for 4 consecutive days on pain intensity and quality of life in patients receiving hemodialysis (HD) treatment and It is a comparison of the follow-up results of the first level Reiki applied within the scope of the doctoral thesis and the second level Reiki applications to be applied within the scope of this study.
Method: The study will be conducted as a pre-test-post-test, double-blind, randomized controlled trial. After obtaining Ethical Committee approval, participants in the Reiki group will receive 20-minute Reiki sessions at the second level daily from 7:00 PM to 9:00 PM for four days, while participants in the sham Reiki group will be informed that distant energy application will be performed but no actual treatment will be administered. The researcher will plan to administer second-level Reiki sessions to 8 patients daily. Throughout the study, patients in both groups will continue their routine treatments. At the beginning and three weeks after the end of the intervention, Kidney Disease Quality of Life Scale (KDQOLTM-36) scores will be collected face-to-face at HD centers, before and after the intervention Visual Analog Scale for Pain (VAS-Pain), additionally, psychodynamic responses experienced during the first and last Reiki sessions will be evaluated by three blinded assessors via telephone in both study groups.
Results: Statistical analyses of the data will be conducted using the Statistical Package for Social Sciences (Version 22.0, SPSS Inc., Chicago, IL, USA, License: Hitit University). Depending on the homogeneity of the data distribution, appropriate parametric or nonparametric tests will be performed for data evaluation.
Read the detailed description
Chronic kidney disease (CKD) is the chronic, progressive and irreversible loss of kidney functions associated with many causes and consists of a total of five clinical stages that require different treatment and care. The fifth of these stages is called end-stage renal disease (ESRD), and hemodialysis (HD) is offered to patients as a renal replacement treatment option unless a successful kidney transplantation occurs at this stage. Although HD treatment is a treatment option that aims to reduce mortality and morbidity rates and improve quality of life, it can also bring about different problems caused by the disease and treatment. Many physical and psychological symptoms are observed in patients receiving HD treatment, such as pain, fatigue, dyspnea, sleep problems, restless legs syndrome, itching, muscle cramps, nausea-vomiting, loss of appetite, constipation, dry skin, sexual dysfunction, anxiety, depression, and delirium. In addition, these symptoms bring about social and economic problems and negatively affect the patient's quality of life. In patients with ESRD and receiving HD treatment; The most common symptom is pain due to reasons such as accumulation of fluid and metabolic wastes, comorbid causes such as diabetes, cardiovascular and pulmonary diseases, infections, changes in the musculoskeletal system, HD procedure, carpal tunnel syndrome, and anxiety. It is known that hemodialysis patients experience moderate to severe pain, and unless the pain they experience is eliminated, the quality of life of individuals and their motivation for the continuity of treatment are negatively affected. Therefore, the importance of pain management in these patients increases considerably. The essence of effective pain management is a multidisciplinary approach and the combined use of pharmacological and non-pharmacological methods. When the studies are examined, it is seen that pharmacological and/or complementary and integrative treatment (TIT) methods are used in the management of pain in patients receiving HD treatment. In pharmacological treatment, non-opioid analgesics such as acetaminophen, topical analgesics, gabapentinoids and tricyclic antidepressants are primarily preferred. However, patients' inability to fully express their pain, their unwillingness to increase the already existing medication load, fear of addiction or side effects of the medications to be used, ethnic or cultural factors, healthcare professionals' inability to adequately evaluate pain and lack of training in pain management are among the reasons for HD patients. There are difficulties in pain management due to reasons such as the lack of a guide on pain management. For this reason, patients prefer TIT methods such as yoga, reflexology, music therapy, relaxation exercises, aromatherapy, acupressure and Reiki instead of drug treatment.
Reiki, one of the energy-based treatments that has attracted great attention from nurses among TIT methods in recent years; It provides physical, mental and emotional healing by balancing the disrupted energy flow.
While only two studies examining the effect of Reiki on pain in patients receiving HD treatment have been found in the literature, no studies investigating its effect on quality of life have been found. Reiki is a method that can be easily learned, is non-invasive, does not require special equipment, is cost-free, easy to apply, reduces the use of analgesics and has no side effects. In addition, when applied together with standard treatment, it stands out as one of the different approaches that nurses can offer to the patient in providing pain management, as it increases the quality of life by reducing the severity of pain. Based on this point, the doctoral thesis titled "The Effect of Reiki Application on Pain Intensity and Quality of Life in Patients Receiving Hemodialysis Treatment" has a mixed design; It was conducted as a pretest-posttest, double-blind, randomized controlled study and a qualitative study with individual in-depth interviews. In the study data, it was observed that first level Reiki, applied for a total of 12 sessions for 30 minutes three times a week in the first three hours of HD, reduced the severity of pain, improved mental health, and positively affected the quality of life by reducing the symptoms and problems of kidney disease. The fact that first level Reiki application takes a long time puts pressure on the practitioner, considering the other workloads of nurse practitioners, and a limited number of patients can benefit from this application.There is also a second level (distance) Reiki application in the literature that has been applied to different patient groups and examines the effect of Reiki on pain intensity. In addition, no study has been found in the literature examining the effect of second-level Reiki on pain intensity and quality of life in HD patients, nor has there been any study examining how long the effect of Reiki application lasts. Therefore, this study aims to determine the effect of 20-minute second-level Reiki application for 4 consecutive days on pain intensity and quality of life in patients receiving HD treatment and to compare the follow-up results of first-level Reiki and second-level Reiki applications.
- Conditions
- Hemodialysis
- Being tested
- Distance Reiki, Sham Reiki
- Keywords
- Hemodialysis, Distance Reiki, Pain, Quality of life, Nursing
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distance ReikiOther
According to Usui, the second level Reiki application will be applied for 20 minutes a day between 19.00 and 21.00 in the evening for four consecutive days by the researcher who has completed his second level training, in accordance with the "Second Level Reiki Application Protocol".
Sham ReikiOther
It will be stated that remote energy application will be applied to the Sham Reiki group and no application will be made.
| Study group | Role | What they receive |
|---|---|---|
| Distance Reiki Group | Experimental | According to Usui, the second level Reiki application will be applied for 20 minutes a day between 19.00 and 21.00 in the evening for four consecutive days by the researcher who has completed his second level training, in accordance with the "Second Level Reiki Application Protocol". Receives: Other: Distance Reiki |
| Sham Reiki Group | Sham comparator | It will be stated that remote energy application will be applied to the Sham Reiki group and no application will be made. Receives: Other: Sham Reiki |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity measurement
"Visual Analog Scale (VAS-Pain)" was applied to the patients in the Reiki and sham Reiki groups before and after application. In VAS-Pain, 1-3 cm is considered a "mild pain" score, 4-6 cm is considered a "moderate pain" score, and 7-10 cm is considered a "severe pain" score.
Measured: Day 1
Initial quality of life measurement
Initial quality of life measurement, "Kidney Disease Quality of Life -KDQOLTM-36" were applied to the patients in the Reiki and sham Reiki groups. Scores in each subscale of the KDQOLTM-36 scale range from 0 to 100, with higher scores indicating better health-related quality of life.
Measured: Day 1
Secondary outcomes (2)
Pain severity measurement at the end of the 4th session
"Visual Analog Scale (VAS-Pain)" was applied to the patients in the Reiki and sham Reiki groups before and after application. In VAS-Pain, 1-3 cm is considered a "mild pain" score, 4-6 cm is considered a "moderate pain" score, and 7-10 cm is considered a "severe pain" score.
Measured: Day 4
Quality of life measurement at the end of 4 week later
Quality of life measurement at the end of 4 week later, "Kidney Disease Quality of Life -KDQOLTM-36" were applied to the patients in the Reiki and sham Reiki groups. Scores in each subscale of the KDQOLTM-36 scale range from 0 to 100, with higher scores indicating better health-related quality of life.
Measured: 4 week later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Oct 2024
- Primary completion28 Oct 2024
- Study completion14 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Mersin 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Sultan ÇEÇEN, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519136
- Sponsor's protocol ID
- Distance Reiki
- Status last verified
- Nov 2024
- First submitted
- 19 Jul 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participation data will be made available for all outcome measure
Publications
Yilmaz CK, Karakoyun A, Yurtsever S. The Effect of Distant Reiki Applied to Individuals with Extremity Amputation on Pain Level and Holistic Well-Being: A Quasi-experimental Study. Pain Manag Nurs. 2024 Apr;25(2):e87-e92. doi: 10.1016/j.pmn.2023.11.003. Epub 2023 Nov 28.
PubMed 38030555Unal N, Bektas Akpinar N, Bek D, Yurtsever S. The Effect of Reiki on Pain, Functional Status, and Holistic Well-Being in Patients With Knee Osteoarthritis: A Randomized Controlled Trial. Orthop Nurs. 2024 Mar-Apr 01;43(2):109-118. doi: 10.1097/NOR.0000000000001017.
PubMed 38546686Cecen S, Tasci S. Impact of Reiki Levels 1 and 2 on Pain and Quality of Life Among Hemodialysis Patients: A Comparative Study. J Holist Nurs. 2025 Nov 20:8980101251393300. doi: 10.1177/08980101251393300. Online ahead of print.
PubMed 41264460
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reiki Therapy on Pain Severity and Quality of Life in Patients Undergoing Hemodialysis: A Follow-Up and Evaluation Study of First-Level Reiki Versus Second-Level Reiki Application
- ClinicalTrials.gov ID
- NCT06519136
- Acronym / sponsor ID
- Distance Reiki
- Conditions
- Hemodialysis
- Keywords
- Hemodialysis, Distance Reiki, Pain, Quality of life, Nursing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 28 Oct 2024 (actual)
- Study completion
- 14 Dec 2024 (estimated)
- First posted
- 25 Jul 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.
Purpose: The aim of this study is to determine the effect of 20-minute second-level Reiki application for 4 consecutive days on pain intensity and quality of life in patients receiving hemodialysis (HD) treatment and It is a comparison of the follow-up results of the first level Reiki applied within the scope of the doctoral thesis and the second level Reiki applications to be applied within the scope of this study.
Method: The study will be conducted as a pre-test-post-test, double-blind, randomized controlled trial. After obtaining Ethical Committee approval, participants in the Reiki group will receive 20-minute Reiki sessions at the second level daily from 7:00 PM to 9:00 PM for four days, while participants in the sham Reiki group will be informed that distant energy application will be performed but no actual treatment will be administered. The researcher will plan to administer second-level Reiki sessions to 8 patients daily. Throughout the study, patients in both groups will continue their routine treatments. At the beginning and three weeks after the end of the intervention, Kidney Disease Quality of Life Scale (KDQOLTM-36) scores will be collected face-to-face at HD centers, before and after the intervention Visual Analog Scale for Pain (VAS-Pain), additionally, psychodynamic responses experienced during the first and last Reiki sessions will be evaluated by three blinded assessors via telephone in both study groups.
Results: Statistical analyses of the data will be conducted using the Statistical Package for Social Sciences (Version 22.0, SPSS Inc., Chicago, IL, USA, License: Hitit University). Depending on the homogeneity of the data distribution, appropriate parametric or nonparametric tests will be performed for data evaluation.
Detailed description
Chronic kidney disease (CKD) is the chronic, progressive and irreversible loss of kidney functions associated with many causes and consists of a total of five clinical stages that require different treatment and care. The fifth of these stages is called end-stage renal disease (ESRD), and hemodialysis (HD) is offered to patients as a renal replacement treatment option unless a successful kidney transplantation occurs at this stage. Although HD treatment is a treatment option that aims to reduce mortality and morbidity rates and improve quality of life, it can also bring about different problems caused by the disease and treatment. Many physical and psychological symptoms are observed in patients receiving HD treatment, such as pain, fatigue, dyspnea, sleep problems, restless legs syndrome, itching, muscle cramps, nausea-vomiting, loss of appetite, constipation, dry skin, sexual dysfunction, anxiety, depression, and delirium. In addition, these symptoms bring about social and economic problems and negatively affect the patient's quality of life. In patients with ESRD and receiving HD treatment; The most common symptom is pain due to reasons such as accumulation of fluid and metabolic wastes, comorbid causes such as diabetes, cardiovascular and pulmonary diseases, infections, changes in the musculoskeletal system, HD procedure, carpal tunnel syndrome, and anxiety. It is known that hemodialysis patients experience moderate to severe pain, and unless the pain they experience is eliminated, the quality of life of individuals and their motivation for the continuity of treatment are negatively affected. Therefore, the importance of pain management in these patients increases considerably. The essence of effective pain management is a multidisciplinary approach and the combined use of pharmacological and non-pharmacological methods. When the studies are examined, it is seen that pharmacological and/or complementary and integrative treatment (TIT) methods are used in the management of pain in patients receiving HD treatment. In pharmacological treatment, non-opioid analgesics such as acetaminophen, topical analgesics, gabapentinoids and tricyclic antidepressants are primarily preferred. However, patients' inability to fully express their pain, their unwillingness to increase the already existing medication load, fear of addiction or side effects of the medications to be used, ethnic or cultural factors, healthcare professionals' inability to adequately evaluate pain and lack of training in pain management are among the reasons for HD patients. There are difficulties in pain management due to reasons such as the lack of a guide on pain management. For this reason, patients prefer TIT methods such as yoga, reflexology, music therapy, relaxation exercises, aromatherapy, acupressure and Reiki instead of drug treatment.
Reiki, one of the energy-based treatments that has attracted great attention from nurses among TIT methods in recent years; It provides physical, mental and emotional healing by balancing the disrupted energy flow.
While only two studies examining the effect of Reiki on pain in patients receiving HD treatment have been found in the literature, no studies investigating its effect on quality of life have been found. Reiki is a method that can be easily learned, is non-invasive, does not require special equipment, is cost-free, easy to apply, reduces the use of analgesics and has no side effects. In addition, when applied together with standard treatment, it stands out as one of the different approaches that nurses can offer to the patient in providing pain management, as it increases the quality of life by reducing the severity of pain. Based on this point, the doctoral thesis titled "The Effect of Reiki Application on Pain Intensity and Quality of Life in Patients Receiving Hemodialysis Treatment" has a mixed design; It was conducted as a pretest-posttest, double-blind, randomized controlled study and a qualitative study with individual in-depth interviews. In the study data, it was observed that first level Reiki, applied for a total of 12 sessions for 30 minutes three times a week in the first three hours of HD, reduced the severity of pain, improved mental health, and positively affected the quality of life by reducing the symptoms and problems of kidney disease. The fact that first level Reiki application takes a long time puts pressure on the practitioner, considering the other workloads of nurse practitioners, and a limited number of patients can benefit from this application.There is also a second level (distance) Reiki application in the literature that has been applied to different patient groups and examines the effect of Reiki on pain intensity. In addition, no study has been found in the literature examining the effect of second-level Reiki on pain intensity and quality of life in HD patients, nor has there been any study examining how long the effect of Reiki application lasts. Therefore, this study aims to determine the effect of 20-minute second-level Reiki application for 4 consecutive days on pain intensity and quality of life in patients receiving HD treatment and to compare the follow-up results of first-level Reiki and second-level Reiki applications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Distance Reiki Group | Experimental | Other: Distance ReikiAccording to Usui, the second level Reiki application will be applied for 20 minutes a day between 19.00 and 21.00 in the evening for four consecutive days by the researcher who has completed his second level training, in accordance with the "Second Level Reiki Application Protocol". |
| Sham Reiki Group | Sham comparator | Other: Sham ReikiIt will be stated that remote energy application will be applied to the Sham Reiki group and no application will be made. |
Who may qualify
- Ages
- 28 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who volunteered to participate in the research and received first level Reiki within the scope of the study titled "The effect of Reiki application on pain severity and quality of life in patients receiving hemodialysis treatment",
- In patients over 65 years of age, patients with a Standardized Mini Mental Test (SMMT) score of 24 points and above will be included in the sample.
Key exclusion criteria (6 listed)
- Those who do not volunteer to participate in the research,
- Deceased,
- Changing the treatment center,
- Starting to receive peritoneal dialysis treatment or having renal transplantation,
- Using another complementary integrative therapy application,
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 |
|---|---|---|
| Distance ReikiAccording to Usui, the second level Reiki application will be applied for 20 minutes a day between 19.00 and 21.00 in the evening for four consecutive days by the researcher who has completed his second level training, in accordance with the "Second Level Reiki Application Protocol". | Other | Distance Reiki Group |
| Sham ReikiIt will be stated that remote energy application will be applied to the Sham Reiki group and no application will be made. | Other | Sham Reiki Group |
Primary outcome
Pain severity measurement
Time frame: Day 1
"Visual Analog Scale (VAS-Pain)" was applied to the patients in the Reiki and sham Reiki groups before and after application. In VAS-Pain, 1-3 cm is considered a "mild pain" score, 4-6 cm is considered a "moderate pain" score, and 7-10 cm is considered a "severe pain" score.
Initial quality of life measurement
Time frame: Day 1
Initial quality of life measurement, "Kidney Disease Quality of Life -KDQOLTM-36" were applied to the patients in the Reiki and sham Reiki groups. Scores in each subscale of the KDQOLTM-36 scale range from 0 to 100, with higher scores indicating better health-related quality of life.
2 secondary outcomes
Pain severity measurement at the end of the 4th session
Time frame: Day 4
Quality of life measurement at the end of 4 week later
Time frame: 4 week later
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 4 Dec 2024.
- Background: PubMed 38030555Yilmaz CK, Karakoyun A, Yurtsever S. The Effect of Distant Reiki Applied to Individuals with Extremity Amputation on Pain Level and Holistic Well-Being: A Quasi-experimental Study. Pain Manag Nurs. 2024 Apr;25(2):e87-e92. doi: 10.1016/j.pmn.2023.11.003. Epub 2023 Nov 28.
- Background: PubMed 38546686Unal N, Bektas Akpinar N, Bek D, Yurtsever S. The Effect of Reiki on Pain, Functional Status, and Holistic Well-Being in Patients With Knee Osteoarthritis: A Randomized Controlled Trial. Orthop Nurs. 2024 Mar-Apr 01;43(2):109-118. doi: 10.1097/NOR.0000000000001017.
- Derived from this study: PubMed 41264460Cecen S, Tasci S. Impact of Reiki Levels 1 and 2 on Pain and Quality of Life Among Hemodialysis Patients: A Comparative Study. J Holist Nurs. 2025 Nov 20:8980101251393300. doi: 10.1177/08980101251393300. Online ahead of print.
- Individual participant dataSharing planned: Yes. De-identified individual participation data will be made available for all outcome measure
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distance Reiki in people with Hemodialysis, run by Mersin 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 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2024. 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. Some participants in this study may receive a placebo. 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 Sultan Çeçen (+90 364 223 15 61 ext. 3006, sultancecen@hitit.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain severity measurement (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06519136, which also lists 3 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 Dec 2024.