Diabetes MellitusNCT07356024
Effect of Acupressure on Blood Glucose And Anxiety in Elderly With Diabetes
A study testing Acupressure and Routine care in people with Diabetes Mellitus and Acupressure, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Acupressure
- What is being tested?
- Acupressure and Routine care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Feb 2026to 27 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bolu Abant Izzet Baysal University
Bolu
Saadet Can Çiçek, +905062846936
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Acupressure
- Being tested
- Acupressure, Sham Acupressure, Routine care
- Keywords
- Randomized Controlled Trial, Diabetes, Elderly, Acupressure, Anxiety, Blood Glucose
- Medical subject headings
- Diabetes Mellitus, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureOther
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 AcupressureOther
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 careOther
Participants will receive routine clinical care only and no additional intervention.
| Study group | Role | What they receive |
|---|---|---|
| Acupressure Group | Experimental | Participants 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. Receives: Other: Acupressure |
| Sham Group | Sham 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. Receives: Other: 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. Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose
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.
Measured: 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.
Measured: Baseline to Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start16 Feb 2026
- Primary completion24 Aug 2026
- Study completion27 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of three parallel groups: an acupressure intervention group, a sham acupressure group, or a control group receiving routine care.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saadet Can Çiçek, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356024
- Sponsor's protocol ID
- BAIBU-SBF-YO-2025
- Status last verified
- Oct 2026
- First submitted
- 11 Jan 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07356024
- Acronym / sponsor ID
- BAIBU-SBF-YO-2025
- Conditions
- Diabetes Mellitus, Acupressure
- Keywords
- Randomized Controlled Trial, Diabetes, Elderly, Acupressure, Anxiety, Blood Glucose
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- 24 Aug 2026 (actual)
- Study completion
- 27 Oct 2026 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants are randomly assigned to one of three parallel groups: an acupressure intervention group, a sham acupressure group, or a control group receiving routine care.
| Arm | Type | Receives |
|---|---|---|
| Acupressure Group | Experimental | Other: 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 Group | Sham comparator | Other: 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) | Other | Other: Routine careParticipants assigned to this group will receive routine clinical care only and will not receive any additional intervention during the study period. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupressureThe 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 | Other | Acupressure Group |
| Sham AcupressureParticipants 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. | Other | Sham Group |
| Routine careParticipants will receive routine clinical care only and no additional intervention. | Other | Control Group (Routine Care) |
Primary outcome
Blood Glucose
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure and Routine care in people with Diabetes Mellitus and Acupressure, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saadet CAN ÇİÇEK (+905062846936, saadet.cancicek@ibu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Glucose (time frame: Baseline to Day 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.