Effect of Acupressure on Blood Glucose And Anxiety in Elderly With Diabetes: A Three Arm, Parallel Group, Double Blind, A Randomized Controlled Trial
| Registry | NCT07356024 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, supportive care |
| Enrollment | 48 (Estimated) |
| Sponsor | Abant Izzet Baysal University (Other) |
| Conditions | Diabetes Mellitus, Acupressure |
| Interventions | Acupressure, Sham Acupressure, Routine care (Other) |
| Dates | start 2026-02-16, primary completion 2026-08-24, completion 2026-10-27 (estimated), first posted 2026-01-21, last updated 2026-10-09 |
| Locations | 1 site in Turkey (Türkiye) |
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All trials for Diabetes Mellitus All trials for Acupressure All trials of Acupressure All trials of Sham Acupressure
This study aims to evaluate the effects of acupressure on blood glucose levels and anxiety in older adults with diabetes. A three-arm randomized controlled trial will be conducted, comparing acupressure, sham acupressure, and routine care groups. Fasting and postprandial blood glucose levels will be assessed as primary outcomes, and state anxiety will be assessed as a secondary outcome.
Diabetes is a common chronic disease in older adults and may be associated with difficulties in maintaining optimal blood glucose levels and increased anxiety. This study is designed to evaluate the effects of acupressure on blood glucose levels and anxiety in older adults with diabetes. This is a three-arm, parallel-group, double-blind randomized controlled trial. Participants will be randomly assigned in a 1:1:1 ratio to an acupressure group, a sham acupressure group, or a routine care control group. Participants in the intervention group will receive acupressure applied to the HT7, SP6, and ST36 acupoints by a trained researcher. The intervention will be administered once daily for six sessions, with each session lasting approximately 15-20 minutes. The sham acupressure group will receive light pressure applied to non-acupoint areas near the same anatomical regions, while the control group will continue to receive routine clinical care without any additional intervention. The primary outcome of the study is blood glucose level, assessed using fasting and postprandial capillary blood glucose measurements at baseline and at predefined time points during the intervention period. Secondary outcomes include anxiety levels, measured using the State-Trait Anxiety Inventory.Outcome assessments will be conducted by assessors blinded to group allocation. Prior to the main trial, a pilot study will be conducted to evaluate the feasibility of the intervention protocol and data collection procedures, and to estimate the effect size required for calculating the final sample size of the main study. Findings from the pilot study will be used to refine the intervention procedures and to determine the final sample size. Participants included in the pilot study will not be included in the main trial.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Acupressure Group | Experimental | Other: Acupressure | Participants assigned to this group will receive acupressure treatment at points HT7, SP6, and ST36 by a trained researcher. The intervention will be administered once daily for six days, in addition to routine clinical care, with each session lasting approximately 15-20 minutes. |
| Sham Group | Sham comparator | Other: Sham Acupressure | Participants assigned to this group will receive sham acupressure, consisting of light pressure applied to non-acupoint areas near the same anatomical regions as the intervention group. |
| Control Group (Routine Care) | Other | Other: Routine care | Participants assigned to this group will receive routine clinical care only and will not receive any additional intervention during the study period. |
Sex: All, ages: 65 Years to any, accepts healthy volunteers
Inclusion Criteria: * Being 65 years of age or older, * Having been diagnosed with diabetes for at least one year, * There should be no hearing, speech, or vision problems that would hinder the exchange and communication of the information, * Being able to speak and understand Turkish, * Not using any other complementary or supportive therapies during the study period, * Successfully passing the mini mental and cognitive assessment routinely performed in the clinic, * Continuing routine diabetes treatment for the past month. Exclusion Criteria: * The presence of open wounds, infections, skin lesions, or anatomical abnormalities in the areas where acupressure will be applied, * Discontinuing prescribed diabetes treatment or showing significant non-adherence to treatment regimen during the investigation period.
| Facility | City | Country | Status |
|---|---|---|---|
| Bolu Abant Izzet Baysal University | Bolu | Turkey (Türkiye) | Recruiting |