Chronic Kidney Disease Stage 5 (Disorder)NCT05971134
Acupressure and Fistula Needle Insert Pain Management
A study testing Acupreesure applied in people with Chronic Kidney Disease Stage 5 (Disorder), run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Introduction: This study was conducted to determine the effectiveness of acupressure application on Hegu (LI4) point on the severity of acute pain caused by fistula needle in patients with brescia-cimino, snuff-box and antecubital fistula. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease Stage 5 (Disorder)
- What is being tested?
- Acupreesure applied
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 1 Jul 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 18 years or older have brescia-cimino, snuff-box or antecubital fistula speak Turkish have hemodialysis(HD) treatment three times a week have not used analgesics in the last 6 hours had no pain who volunteered to participate in the study.
- Exclusion Criteria With aneurysmatic fistula had soft tissue damage infection in extremities has coagulations and bleeding problems.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Acupressure Applied to Different Fistula Area on Fistula Needle Insert Pain: A Randomized Clinical Trial
Introduction: This study was conducted to determine the effectiveness of acupressure application on Hegu (LI4) point on the severity of acute pain caused by fistula needle in patients with brescia-cimino, snuff-box and antecubital fistula.
Methods: This study was randomized control study which was conducted with 66 intervention and 65 control participants. The participants in the intervention group were divided into 3 groups according to the fistula area. Data were collected using Descriptive Information Form and pain scale.
Read the detailed description
This study is determined that finger acupuncture at L14 point reduces the severity of pain felt by the patient during fistula needle insertion. Acute pain during puncture of arteriovenous fistula is a common problem in hemodialysis patients. Moreover, patients experience this acute pain three times a week. Accordingly, acupressure applied to the L4 acupuncture point can be considered as an effective, simple and low-cost non-pharmacological method to reduce acute pain during needle insertion in patients. Since this application is non-invasive and does not carry the risk of complications, it can be taught to patients and/or nurses to contribute to the management of acute pain. In addition, in this article, we examined the effect of acupressure applied only to the LI4 acupuncture point on pain intensity during fistula needle insertion, therefore, we suggest designing different studies with different acupuncture points (effective in reducing pain).
- Being tested
- Acupreesure applied
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupreesure appliedBehavioural
Acupressure was applied to the LI4 acupuncture point for 3 minutes by the researcher for the intervention group
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Intervention group 1 consisted of patients with brescia-cimino fistula Intervention group 2 consisted of patients with snuff-box fistula Intervention group 3 consisted of patients with antecubital fistula. Receives: Behavioral: Acupreesure applied |
| Control Group | No intervention | Control group 1 consisted of patients with brescia-cimino fistula Control group 2 consisted of patients with snuff-box fistula Control group 3 consisted of patients with antecubital fistula. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale was used to determine the severity of acute pain experienced by patients during fistula needle insertion.
The pain severity of the patient is determined with the Numeric Rating Scale. NRS includes numbers from 0 to 10. The meaning of the number "0" on the scale is "I have no pain" and the number "10" means "I have very severity pain".
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 Oct 2022
- Primary completion1 Feb 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Stage 5 (Disorder)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülay Turgay, Baskent University
- Investigators
- Assistant prof. GÜLAY TURGAY, Principal investigator, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971134
- Sponsor's protocol ID
- Acupressure
- Status last verified
- Jul 2023
- First submitted
- 18 Jul 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After the article is published
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupressure Applied to Different Fistula Area on Fistula Needle Insert Pain: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05971134
- Acronym / sponsor ID
- Acupressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 2 Aug 2023 (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.
Introduction: This study was conducted to determine the effectiveness of acupressure application on Hegu (LI4) point on the severity of acute pain caused by fistula needle in patients with brescia-cimino, snuff-box and antecubital fistula.
Methods: This study was randomized control study which was conducted with 66 intervention and 65 control participants. The participants in the intervention group were divided into 3 groups according to the fistula area. Data were collected using Descriptive Information Form and pain scale.
Detailed description
This study is determined that finger acupuncture at L14 point reduces the severity of pain felt by the patient during fistula needle insertion. Acute pain during puncture of arteriovenous fistula is a common problem in hemodialysis patients. Moreover, patients experience this acute pain three times a week. Accordingly, acupressure applied to the L4 acupuncture point can be considered as an effective, simple and low-cost non-pharmacological method to reduce acute pain during needle insertion in patients. Since this application is non-invasive and does not carry the risk of complications, it can be taught to patients and/or nurses to contribute to the management of acute pain. In addition, in this article, we examined the effect of acupressure applied only to the LI4 acupuncture point on pain intensity during fistula needle insertion, therefore, we suggest designing different studies with different acupuncture points (effective in reducing pain).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: Acupreesure appliedIntervention group 1 consisted of patients with brescia-cimino fistula Intervention group 2 consisted of patients with snuff-box fistula Intervention group 3 consisted of patients with antecubital fistula. |
| Control Group | No intervention | –Control group 1 consisted of patients with brescia-cimino fistula Control group 2 consisted of patients with snuff-box fistula Control group 3 consisted of patients with antecubital fistula. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older have brescia-cimino, snuff-box or antecubital fistula speak Turkish have hemodialysis(HD) treatment three times a week have not used analgesics in the last 6 hours had no pain who volunteered to participate in the study.
- Exclusion Criteria With aneurysmatic fistula had soft tissue damage infection in extremities has coagulations and bleeding problems.
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 |
|---|---|---|
| Acupreesure appliedAcupressure was applied to the LI4 acupuncture point for 3 minutes by the researcher for the intervention group | Behavioural | experimental group |
Primary outcome
Numeric Rating Scale was used to determine the severity of acute pain experienced by patients during fistula needle insertion.
Time frame: 1 week
The pain severity of the patient is determined with the Numeric Rating Scale. NRS includes numbers from 0 to 10. The meaning of the number "0" on the scale is "I have no pain" and the number "10" means "I have very severity pain".
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 2 Aug 2023.
- Individual participant dataSharing planned: No. After the article is published
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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.
Assistant prof. GÜLAY TURGAY principal investigator
Baskent 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 Acupreesure applied in people with Chronic Kidney Disease Stage 5 (Disorder), run by Baskent 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 2 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 2 Aug 2023. 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?
Numeric Rating Scale was used to determine the severity of acute pain experienced by patients during fistula needle insertion. (time frame: 1 week). 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 2 Aug 2023.