NCT06979739

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 20, 2025

Completed
Last Updated

May 20, 2025

Status Verified

May 1, 2025

Enrollment Period

Same day

First QC Date

April 6, 2025

Last Update Submit

May 16, 2025

Conditions

Keywords

diabetic neuropathy

Outcome Measures

Primary Outcomes (2)

  • Douleur Neuropathique 4 Questions-DN4

    6 MOUNTH

  • visual analog scale

    pain

    6 MOUNTH

Study Arms (4)

1

EXPERIMENTAL
Behavioral: reiki

2

EXPERIMENTAL
Behavioral: refleksologia

3

NO INTERVENTION

4

EXPERIMENTAL
Behavioral: reiki and refleksologia

Interventions

reikiBEHAVIORAL

6 week reiki

1
refleksologiaBEHAVIORAL

6 week refleksologia

2

6 week reiki and refleksologia

4

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Adana City Hospital

Adana, Adana, Turkey (Türkiye)

Location

Adana Hospital

Adana, Adana, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual Therapies

Study Officials

  • PINAR ŞAHİN

    www.hku.edu.tr

    PRINCIPAL INVESTIGATOR
  • nermin olgun

    www.hku.edu.tr

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

April 6, 2025

First Posted

May 20, 2025

Study Start

June 15, 2024

Primary Completion

June 15, 2024

Study Completion

January 15, 2025

Last Updated

May 20, 2025

Record last verified: 2025-05

Locations