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Not yet recruiting NCT07356024

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

No phase Interventional Diabetes Mellitus Acupressure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acupressure, Placebo Sham Acupressure, Routine care.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Acupressure. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Acupressure on Blood Glucose And Anxiety in Elderly With Diabetes: A Three Arm, Parallel Group, Double Blind, A Randomized Controlled Trial

Overview

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.

Detailed 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.

Interventions

  • Other Acupressure
    The acupressure intervention will be conducted in a designated room at the institution, once daily for 6 consecutive days, with each session lasting 15-20 minutes, totaling 6 sessions. During the first 3-5 minutes of each session, participants will be guided to the appropriate position and approached to ensure comfort. Acupressure will then be applied to a total of six points: both wrists (HT7) and both legs (ST36, SP6), with two points on each limb. Each of the six points will receive a 30-seco
  • Other Placebo Sham Acupressure
    Participants in the placebo group will receive sham acupressure administered by the researcher in a quiet, designated room at the institution, once daily for 6 consecutive days, with each session lasting 15-20 minutes, totaling 6 sessions. Pressure will be applied to bony areas approximately 1.5-2 cm away from the HT7, SP6, and ST36 points, where no meridians pass. Prior to the application, the sham points will be gently warmed and massaged for approximately 20 seconds to reduce tissue sensitivi
  • Other Routine care
    Participants will receive routine clinical care only and no additional intervention.

Primary outcome measures

  • Blood Glucose [Time frame: Baseline to Day 6]
  • Anxiety [Time frame: Baseline to Day 6]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Bolu Abant Izzet Baysal University — Bolu

Identifiers

NCT: NCT07356024 · BAIBU-SBF-YO-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗