Type 2 DiabetesNCT06936956
The Effect of Acupressure on Polyneuropathy-related Pain and Sleep Quality
A study testing Acupressure in people with Type 2 Diabetes, run by Giresun University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to determine the effect of acupressure on polyneuropathy-related pain and sleep quality in patients with type 2 diabetes. A randomized controlled experimental design was employed in the study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jan 2019to 12 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Were between the ages of 18-65 years old
- Resided in the city center
- Had no additional diseases that could cause sensory neuropathy, such as peripheral arterial disease, peripheric vein disease, nervous system diseases, benign or malign tumor, chemotherapy history, carpal tunnel syndrome, and arthritis.
- Had no clotting or bleeding disorders
- Were not undergoing dialysis treatment during the study period
- Had no ulcers, physical deformities or foot calluses
- Had no history of analgesic medication, except for medication used for DPN
- Had no physical diseases, cognitive deficiencies or psychiatric disease diagnosis that would prevent understanding of the questions on the scales used for data collection.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Endocrinology Clinic and Outpatient Clinic of a Atatürk University Hospital
Erzurum, 25000
About this study
Official title: The Effect of Acupressure on Polyneuropathy-related Pain and Sleep Quality in Patients With Type 2 Diabetes
This study aimed to determine the effect of acupressure on polyneuropathy-related pain and sleep quality in patients with type 2 diabetes. A randomized controlled experimental design was employed in the study. The study sample consisted of 86 patients with type 2 diabetes (44 in the acupressure group and 42 in the control group) who met the inclusion criteria and agreed to participate. Participants were randomly assigned to either the experimental or control group. The experimental group received six sessions of acupressure over six consecutive days, while the control group received no intervention. Data were collected using a personal information form, the Pain Quality Assessment Scale (PQAS), and the Pittsburgh Sleep Quality Index (PSQI). Statistical analyses were conducted using SPSS for Windows 22. Acupressure was found to reduce polyneuropathy-related pain and enhance sleep quality in patients with type 2 diabetes. Therefore, acupressure may be considered an alternative nursing intervention for individuals with type 2 diabetes.
- Conditions
- Type 2 Diabetes
- Being tested
- Acupressure
- Keywords
- Acupressure, diabetes, nursing, polyneuropathy, sleep quality
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Polyneuropathies, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureOther
Acupressure is a noninvasive type of acupuncture. It is applied using fingers, joints or a suitable acupressure tool.
| Study group | Role | What they receive |
|---|---|---|
| Acupressure group | Experimental | Particiants in this group received acupressure application. Receives: Other: Acupressure |
| Control group | No intervention | Participants in this group did not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Quality Assessment Scale (PQAS)
This scale was originally developed by Galer et al. as the Neuropathic Pain Scale and its validity was confirmed with multiple sclerosis patients (Galer\&Jensen 1997). However, this original scale does not include allodynia and paroxysmal pain characteristics, which are common in neuropathic pain syndromes. Jensen et al. developed the Pain Quality Assessment Scale (PQAS) by adding 10 items related to the quality of neuropathic pain, and its validity was confirmed by measuring the neuropathic pain due to carpal tunnel syndrome (Cronbach's alpha 0.87-0.98) (Jense et al.,2006). Şahin et al. adapted the final version of the scale for Turkish society and reported that it is reliable to be used for the cases of diseases with neuropathic pain (Şahin et al., 2010). For the PQAS, it is recommended that no total score be calculated; rather, the three subscales are scored from 0 to 10. In this study, the Cronbach's alpha values were 0.836 for the paroxysmal pain subscale, 0.624 for the surface pa
Measured: 6 days
Pittsburgh Quality of Sleep Index (PQSI)
This questionnaire was developed by Buysse et al. and was confirmed to have a high internal consistency (Cronbach's alpha=0.75), test-retest reliability, and validity (Buyyse et al., 1989). A study was conducted to confirm the Turkish validity and reliability of the questionnaire (Cronbach alpha=0.660) (Ağargün\&Anlar 1996). Each item of the questionnaire is scored between 0 and 3, and the total PQSI score, which ranges between 0 and 21, is obtained by adding the subscale scores. A PSQI score between 0 and 4 indicates a good quality of sleep, while a score between 5 and 21 indicates a bad quality of sleep (Ağargün\&Anlar 1996). In the present study, Cronbach's alpha value was 0.576 for the total PSQI.
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start17 Jan 2019
- Primary completion15 Jun 2019
- Study completion12 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Gündüz Oruç, Giresun University
- Investigators
- Elanur YILMAZ KARABULUTLU Professör, pHD, Study director, Erzurum Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936956
- Sponsor's protocol ID
- GRU-SBF-FGO-01
- Status last verified
- Apr 2025
- First submitted
- 13 Apr 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I do not want my data to be used by other researchers
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupressure on Polyneuropathy-related Pain and Sleep Quality in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06936956
- Acronym / sponsor ID
- GRU-SBF-FGO-01
- Conditions
- Type 2 Diabetes
- Keywords
- Acupressure, diabetes, nursing, polyneuropathy, sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 12 Jul 2019 (actual)
- First posted
- 20 Apr 2025 (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 aimed to determine the effect of acupressure on polyneuropathy-related pain and sleep quality in patients with type 2 diabetes. A randomized controlled experimental design was employed in the study. The study sample consisted of 86 patients with type 2 diabetes (44 in the acupressure group and 42 in the control group) who met the inclusion criteria and agreed to participate. Participants were randomly assigned to either the experimental or control group. The experimental group received six sessions of acupressure over six consecutive days, while the control group received no intervention. Data were collected using a personal information form, the Pain Quality Assessment Scale (PQAS), and the Pittsburgh Sleep Quality Index (PSQI). Statistical analyses were conducted using SPSS for Windows 22. Acupressure was found to reduce polyneuropathy-related pain and enhance sleep quality in patients with type 2 diabetes. Therefore, acupressure may be considered an alternative nursing intervention for individuals with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupressure group | Experimental | Other: AcupressureParticiants in this group received acupressure application. |
| Control group | No intervention | –Participants in this group did not receive any intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Were between the ages of 18-65 years old
- Resided in the city center
- Had no additional diseases that could cause sensory neuropathy, such as peripheral arterial disease, peripheric vein disease, nervous system diseases, benign or malign tumor, chemotherapy history, carpal tunnel syndrome, and arthritis.
- Had no clotting or bleeding disorders
- Were not undergoing dialysis treatment during the study period
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| AcupressureAcupressure is a noninvasive type of acupuncture. It is applied using fingers, joints or a suitable acupressure tool. | Other | Acupressure group |
Primary outcome
Pain Quality Assessment Scale (PQAS)
Time frame: 6 days
This scale was originally developed by Galer et al. as the Neuropathic Pain Scale and its validity was confirmed with multiple sclerosis patients (Galer\&Jensen 1997). However, this original scale does not include allodynia and paroxysmal pain characteristics, which are common in neuropathic pain syndromes. Jensen et al. developed the Pain Quality Assessment Scale (PQAS) by adding 10 items related to the quality of neuropathic pain, and its validity was confirmed by measuring the neuropathic pain due to carpal tunnel syndrome (Cronbach's alpha 0.87-0.98) (Jense et al.,2006). Şahin et al. adapted the final version of the scale for Turkish society and reported that it is reliable to be used for the cases of diseases with neuropathic pain (Şahin et al., 2010). For the PQAS, it is recommended that no total score be calculated; rather, the three subscales are scored from 0 to 10. In this study, the Cronbach's alpha values were 0.836 for the paroxysmal pain subscale, 0.624 for the surface pa
Pittsburgh Quality of Sleep Index (PQSI)
Time frame: 6 days
This questionnaire was developed by Buysse et al. and was confirmed to have a high internal consistency (Cronbach's alpha=0.75), test-retest reliability, and validity (Buyyse et al., 1989). A study was conducted to confirm the Turkish validity and reliability of the questionnaire (Cronbach alpha=0.660) (Ağargün\&Anlar 1996). Each item of the questionnaire is scored between 0 and 3, and the total PQSI score, which ranges between 0 and 21, is obtained by adding the subscale scores. A PSQI score between 0 and 4 indicates a good quality of sleep, while a score between 5 and 21 indicates a bad quality of sleep (Ağargün\&Anlar 1996). In the present study, Cronbach's alpha value was 0.576 for the total PSQI.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Individual participant dataSharing planned: No. I do not want my data to be used by other researchers
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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. This study is not recruiting at the moment.
Elanur YILMAZ KARABULUTLU Professör, pHD study director
Erzurum Technical University
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 in people with Type 2 Diabetes, run by Giresun 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 8 inclusion and 0 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: finished, as of the sponsor's last update on 20 Apr 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Quality Assessment Scale (PQAS) (time frame: 6 days). 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 20 Apr 2025.