Effect of Acupressure on Blood Glucose And Anxiety in Elderly With Diabetes: A Three Arm, Parallel Group, Double Blind, A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Blood Glucose
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Data collection and data entry will be performed by trained personnel independent of the intervention process. All data will be recorded and entered into the dataset using coded identifiers only. Participants will be blinded to group allocation, and the statistician performing the data analysis will also be blinded to group assignments. The study will therefore be conducted using a double-blind design.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Acupressure Group
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.
干预措施: Acupressure (Other)
Placebo Group
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).
干预措施: Placebo Sham Acupressure (Other)
Control Group (Routine Care)
Participants assigned to this group will receive routine clinical care only and will not receive any additional intervention during the study period.
干预措施: Routine care (Other)
结局指标
主要结局
Blood Glucose
时间窗: Baseline to Day 6
Participant's blood glucose results will be evaluated by capillary blood glucose measurement after at least 8-10 hours of fasting and 2 hours after meals in a postprandial state. Measurement Process: Fasting blood sugar measurement: Fasting blood glucose will be evaluated before starting the application, after 3 sessions and 24 hours after the end of 6 sessions, after an 8-10 hour fast. Postprandial blood glucose measurement: Postprandial blood glucose levels will be assessed at the 2nd hour after the first bite of the meal. The first postprandial blood glucose assessment will take into account the first meal after the first session, the second assessment will take into account the first meal after the 3rd session, and the third assessment will take into account the postprandial blood glucose levels measured at the first meal after the 6th session.
Anxiety
时间窗: Baseline to Day 6
Anxiety levels will be assessed using the Spielberger State-Trait Anxiety Inventory (STAI). The Spielberger State-Trait Anxiety Inventory (STAI) is a validated self-report questionnaire used to assess anxiety. It consists of two distinct subscales: State Anxiety (STAI-S), which measures temporary anxiety related to the individual's current condition, and Trait Anxiety (STAI-T), which measures a person's general and long-term tendency to experience anxiety. Each subscale includes 20 items, with total scores ranging from 20 to 80. Higher scores indicate higher levels of anxiety, while lower scores indicate lower anxiety levels. Measurement Process: Before the intervention, the Spielberger State-Trait Anxiety Inventory (STAI) will be administered. The Spielberger State Anxiety Inventory will be applied to the participants half an hour after the first session, before the sixth session, and half an hour after the completion of the sixth session to assess their current anxiety levels.
次要结局
未报告次要终点
研究者
Saadet Can Çiçek
Associate Professor
Abant Izzet Baysal University