Neuropathic Pain Diagnostic Questionnaire (DN4) ≥ 4NCT06979739
Reiki and Reflexology Massage Diyabetik Neuropathy Pain
A study testing reiki, refleksologia and reiki and refleksologia in people with Neuropathic Pain Diagnostic Questionnaire (DN4) ≥ 4, run by Kahramanmaras Sutcu Imam University at 2 sites in Turkey (Türkiye).
Trial summary
Diabetes Mellitus is a chronic endocrine and metabolic disease that occurs as a result of insufficiency, absence and/or deficiency of the insulin hormone secreted from the beta cells of the pancreas, and is characterized by hyperglycemia, disorders in carbohydrate, protein and fat metabolism, capillary membrane… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Neuropathic Pain Diagnostic Questionnaire (DN4) ≥ 4
- What is being tested?
- reiki, refleksologia and reiki and refleksologia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Jun 2024to 15 Jan 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- PEOPLE WITH NEUROPATHY PAIN NEUROPATHIC PAIN IS POSSIBLE MUST HAVE DIABETES Volunteering to participate in the study,
- Being able to understand and speak Turkish and not having a hearing impairment,
- Not having any diagnosed psychiatric disorder that would reduce the ability to comprehend and understand,
- Agreeing to participate in the study.
- Having no communication problems,
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Adana City Hospital
Adana, Adana
Adana Hospital
Adana, Adana
About this study
Official title: The Effect of Reiki and Reflexology Massage Application on Patient's Quality of Life and Pain Level in Diabetic Neuropathy Pain
Diabetes Mellitus is a chronic endocrine and metabolic disease that occurs as a result of insufficiency, absence and/or deficiency of the insulin hormone secreted from the beta cells of the pancreas, and is characterized by hyperglycemia, disorders in carbohydrate, protein and fat metabolism, capillary membrane changes and accelerated atherosclerosis, and has a high risk of morbidity and early mortality, with the development of macrovascular and microvascular complications and a high cost of care.
Diabetic neuropathy is not always painful, but 12% of all diabetic patients are affected by symptomatic painful diabetic neuropathy, the most common chronic and earliest presenting complication.
Read more
Reflexology is a special pressure technique and energy balancing system that is performed by applying pressure to reflex points with rubbing, patting and squeezing movements to ensure healing. Reflexology; It advocates that stimulating nerve points in the feet and hands with certain techniques produces electrochemical messages, which in turn stimulate the relevant organ with the help of neurons.
Feet are widely preferred for reflexology massage due to their features such as having many nerve endings, more sensitive reflexes, being easily accessible, having a large area, and the effectiveness and comfort of the application. Reflexology massage is a supportive and complementary method, not an alternative to medical treatment.
According to the Reiki principle, everything in the universe, including the human body, consists of energy in the universe, and deviations in the energy field cause diseases.
This study aims to investigate the effects of Reiki and reflexology applications on the patient's quality of life and pain level in diabetic neuropathy pain.
- Being tested
- reiki, refleksologia, reiki and refleksologia
- Keywords
- diabetic neuropathy
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reikiBehavioural
6 week reiki
refleksologiaBehavioural
6 week refleksologia
reiki and refleksologiaBehavioural
6 week reiki and refleksologia
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: reiki |
| 2 | Experimental | Not described Receives: Behavioral: refleksologia |
| 3 | No intervention | Not described |
| 4 | Experimental | Not described Receives: Behavioral: reiki and refleksologia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Douleur Neuropathique 4 Questions-DN4
Measured: 6 MOUNTH
visual analog scale
pain
Measured: 6 MOUNTH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start15 Jun 2024
- Primary completion15 Jun 2024
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic Pain Diagnostic Questionnaire (DN4) ≥ 4Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pinar Sahin, Hasan Kalyoncu University
- Investigators
- PINAR ŞAHİN, Principal investigator, www.hku.edu.trnermin olgun, Study director, www.hku.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979739
- Sponsor's protocol ID
- 2024/38
- Status last verified
- May 2025
- First submitted
- 6 Apr 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reiki and Reflexology Massage Application on Patient's Quality of Life and Pain Level in Diabetic Neuropathy Pain
- ClinicalTrials.gov ID
- NCT06979739
- Acronym / sponsor ID
- 2024/38
- Keywords
- diabetic neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 20 May 2025 (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.
Diabetes Mellitus is a chronic endocrine and metabolic disease that occurs as a result of insufficiency, absence and/or deficiency of the insulin hormone secreted from the beta cells of the pancreas, and is characterized by hyperglycemia, disorders in carbohydrate, protein and fat metabolism, capillary membrane changes and accelerated atherosclerosis, and has a high risk of morbidity and early mortality, with the development of macrovascular and microvascular complications and a high cost of care.
Diabetic neuropathy is not always painful, but 12% of all diabetic patients are affected by symptomatic painful diabetic neuropathy, the most common chronic and earliest presenting complication.
Reflexology is a special pressure technique and energy balancing system that is performed by applying pressure to reflex points with rubbing, patting and squeezing movements to ensure healing. Reflexology; It advocates that stimulating nerve points in the feet and hands with certain techniques produces electrochemical messages, which in turn stimulate the relevant organ with the help of neurons.
Feet are widely preferred for reflexology massage due to their features such as having many nerve endings, more sensitive reflexes, being easily accessible, having a large area, and the effectiveness and comfort of the application. Reflexology massage is a supportive and complementary method, not an alternative to medical treatment.
According to the Reiki principle, everything in the universe, including the human body, consists of energy in the universe, and deviations in the energy field cause diseases.
This study aims to investigate the effects of Reiki and reflexology applications on the patient's quality of life and pain level in diabetic neuropathy pain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: reiki |
| 2 | Experimental | Behavioral: refleksologia |
| 3 | No intervention | – |
| 4 | Experimental | Behavioral: reiki and refleksologia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- PEOPLE WITH NEUROPATHY PAIN NEUROPATHIC PAIN IS POSSIBLE MUST HAVE DIABETES Volunteering to participate in the study,
- Being able to understand and speak Turkish and not having a hearing impairment,
- Not having any diagnosed psychiatric disorder that would reduce the ability to comprehend and understand,
- Agreeing to participate in the study.
- Having no communication problems,
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| reiki6 week reiki | Behavioural | 1 |
| refleksologia6 week refleksologia | Behavioural | 2 |
| reiki and refleksologia6 week reiki and refleksologia | Behavioural | 4 |
Primary outcome
Douleur Neuropathique 4 Questions-DN4
Time frame: 6 MOUNTH
visual analog scale
Time frame: 6 MOUNTH
pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Neuropathic Pain Diagnostic Questionnaire (DN4) ≥ 4
RecruitingObservational study
Hematological Indices and Sympathetic Block Response in Neuropathic Pain
Neuropathic Pain, Neuropathic Pain Diagnostic Questionnaire (DN4) ≥ 4
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.
PINAR ŞAHİN principal investigator
www.hku.edu.tr
nermin olgun study director
www.hku.edu.tr
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reiki, refleksologia and reiki and refleksologia in people with Neuropathic Pain Diagnostic Questionnaire (DN4) ≥ 4, run by Kahramanmaras Sutcu Imam University at 2 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 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Douleur Neuropathique 4 Questions-DN4 (time frame: 6 MOUNTH). 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?
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 20 May 2025.