Effect of Acupressure on Blood Glucose And Anxiety in Elderly With Diabetes

Abant Izzet Baysal University

Status: Not yet enrolling

Conditions: Acupressure; Diabetes Mellitus

Treatments: Other: Placebo Sham Acupressure; Other: Routine care; Other: Acupressure

Study type: Interventional

Funder types: Other

Identifiers

NCT07356024

BAIBU-SBF-YO-2025

Details and patient eligibility

About

This study is designed to evaluate the effect of acupressure on blood glucose levels and anxiety in elderly individuals with diabetes. Participants will be assigned to an acupressure intervention group or a control group. The primary outcome of the study is blood glucose level, which will be assessed at baseline and at the end of the intervention period. Secondary outcomes include anxiety levels.

Full description

This study is a prospective, interventional, randomized, double-blind, controlled trial designed to evaluate the effect of acupressure on blood glucose levels and anxiety in elderly individuals with diabetes. Eligible participants will be randomly assigned to one of three groups: an acupressure intervention group, a sham acupressure (placebo) group, or a control group receiving routine care.

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Voluntarily agreeing to participate in the study,
• Being 65 years of age or older,
• Having been diagnosed with diabetes for at least one year,
• Not having any hearing, speech, or vision impairments that would interfere with communication,
• Being able to speak and understand Turkish,
• Having a Mini-Mental State Examination (MMSE) score of 23 or higher for literate participants and 19 or higher for illiterate participants,
• Not using any other complementary or supportive therapies during the study period,
• Receiving dietary treatment or oral antidiabetic medication for diabetes management,
• Having no skin irritation, ulceration, or other impairment of skin integrity at the application sites.

Exclusion criteria

• Initiation of a new medication with potential effects on blood glucose levels in addition to the current treatment during the study period,
• Use of insulin therapy for diabetes management.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 3 patient groups, including a placebo group

Acupressure Group

Experimental group

Description:

Participants assigned to this 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, in addition to routine clinical care.

Treatment:

Other: Acupressure

Placebo Group

Placebo Comparator group

Description:

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. The sham procedure will be administered once daily for six sessions, with each session lasting approximately 15-20 minutes, in addition to routine clinical care. Pressure will be applied on the bone area where the meridians do not pass, parallel to the points where acupressure is applied to the sham points (approximately 1-1.5 cm away).

Treatment:

Other: Placebo Sham Acupressure

Control Group (Routine Care)

Other group

Description:

Participants assigned to this group will receive routine clinical care only and will not receive any additional intervention during the study period.

Treatment:

Other: Routine care