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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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
• Другое 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
• Другое Routine care
  Participants will receive routine clinical care only and no additional intervention.

Первичные конечные точки

• Blood Glucose [Срок оценки: Baseline to Day 6]
• Anxiety [Срок оценки: Baseline to Day 6]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Bolu Abant Izzet Baysal University — Bolu

Идентификаторы

NCT: NCT07356024 · BAIBU-SBF-YO-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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