A randomized control study to assess the effect of WIBMAS (Warm and Ice Bath Massager) in adults with diabetes mellitus.

Effectiveness of Warm and Ice Bath Massager (WIBMAS) on Diabetic Neuropathic pain, quality of sleep and fatigue and psychological wellbeing among adults with Diabetic Mellitus at rural areas of Puducherry- Randomized control trial - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/105521

Enrollment

172

Registered

2026-03-06

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications

Interventions

Intervention1: WARM AND ICE BATH MASSAGER for diabetic neuropathic pain: WIBMAS refers to the intervention provided by the researcher using self-device Warm Ice Bath Massager for diabetic neuropathic

Eligibility

Inclusion criteria

Inclusion criteria: Adults aged 60 years and above Both male female and transgender participants Adults with Type I or Type II diabetes mellitus Participants with diabetic neuropathic pain Participants residing in rural areas of Puducherry Individuals who are physically able and willing to use the Warm and Ice Bath Massager (WIBMAS) Participants with a stable medication regimen for diabetes management (no recent changes in the last few weeks) Good general health excluding severe comorbidities that might interfere with study participation Individuals who provide informed consent and are willing to comply with the study requirements

Exclusion criteria

Exclusion criteria: Adults with swelling in their legs foot ulcers gangrene or skin infections Individuals who have intolerance to cold or warm temperatures Participants on pain medications or alternative therapies for pain management Adults with debilitating illnesses or severe medical conditions that may interfere with participation Individuals with severe visual or hearing impairments that may affect their ability to use WIBMAS or report outcomes Participants using special footwear for diabetic neuropathy or those who have lost sensation in their feet

Design outcomes

Primary

Measure	Time frame
Reducing the Diabetic Neuropathic Pain and fatigue, improve the quality of sleep and psychological wellbeingTimepoint: 6 WEEKS	—

Secondary

Measure	Time frame
Prevent complication of Diabetic Mellitus Association between WIBMAS Effectiveness and Demographic Factors Timepoint: Follow-up over a period of 1 year. Investigating potential differences in effectiveness based on age, gender, and duration of diabetes.	—

Countries

India

Contacts

Public ContactK. Kalaiarasi

SRI BALAJI VIDYAPEETH UNIVERSITY

kripaangelinea@kgnc.ac.in9715262821

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026