NCT07356024

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
6mo left

Started Jan 2026

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress38%
Jan 2026Oct 2026

First Submitted

Initial submission to the registry

January 11, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

January 24, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2026

Expected
Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

January 11, 2026

Last Update Submit

January 24, 2026

Conditions

Keywords

Randomized Controlled TrialDiabetesElderlyAcupressureAnxietyBlood Glucose

Outcome Measures

Primary Outcomes (2)

  • Blood Glucose

    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.

    Baseline to Day 6

  • Anxiety

    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.

    Baseline to Day 6

Study Arms (3)

Acupressure Group

EXPERIMENTAL

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.

Other: Acupressure

Placebo Group

PLACEBO COMPARATOR

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).

Other: Placebo Sham Acupressure

Control Group (Routine Care)

OTHER

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

Other: Routine care

Interventions

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

Acupressure Group

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 sensitivity, preparing the area for the sham acupressure procedure. In the intervention group, evaluation will be made at the specified frequency, using the same measurement tools and the same measurement methods.

Placebo Group

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

Control Group (Routine Care)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bolu Abant Izzet Baysal University

Bolu, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes MellitusAnxiety Disorders

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Central Study Contacts

Saadet CAN ÇİÇEK

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned to one of three parallel groups: an acupressure intervention group, a sham acupressure (placebo) group, or a control group receiving routine care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 11, 2026

First Posted

January 21, 2026

Study Start

January 24, 2026

Primary Completion

April 24, 2026

Study Completion (Estimated)

October 27, 2026

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations