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

NCT07356024 — Not applicable, Recruiting, 48 participants, Abant Izzet Baysal University

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

RegistryNCT07356024
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, supportive care
Enrollment48 (Estimated)
SponsorAbant Izzet Baysal University (Other)
ConditionsDiabetes Mellitus, Acupressure
InterventionsAcupressure, Sham Acupressure, Routine care (Other)
Datesstart 2026-02-16, primary completion 2026-08-24, completion 2026-10-27 (estimated), first posted 2026-01-21, last updated 2026-10-09
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Diabetes Mellitus All trials for Acupressure All trials of Acupressure All trials of Sham Acupressure

-Summary

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.

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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
Acupressure GroupExperimentalOther: AcupressureParticipants 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 GroupSham comparatorOther: Sham AcupressureParticipants 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)OtherOther: Routine careParticipants assigned to this group will receive routine clinical care only and will not receive any additional intervention during the study period.
  • Acupressure (Other): 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-second preparation followed by 2 minutes of acupressure application
  • Sham Acupressure (Other): 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. In the intervention group, evaluation will be made at the specified frequency, using the same measurement tools and the same measurement methods.
  • Routine care (Other): Participants will receive routine clinical care only and no additional intervention.

+Outcome measures

Primary outcomes

  • Blood Glucose [Baseline to Day 6]: Participants' blood glucose results will be assessed by capillary blood glucose measurement after at least 8-10 hours of fasting and 2 hours after meals. Measurement Process: Fasting blood sugar measurement: Fasting blood glucose measurement: This will be assessed before the start of the treatment, 24 hours after the completion of 3 sessions, and 24 hours after the completion 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 main meal after the first session, the second assessment will take into account the first main meal after the 3rd session, and the third assessment will take into account the postprandial blood glucose levels measured at the first main meal after the 6th session.
  • Anxiety [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.

+Eligibility

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.

+Locations (1)

FacilityCityCountryStatus
Bolu Abant Izzet Baysal UniversityBoluTurkey (Türkiye)Recruiting