Renal DialysisNCT05729113
Pain Perception by the Chronic Renal Patient at the Time of Vascular Access Cannulation.
A study testing Distraction technique in people with Renal Dialysis, run by Joana Sofia Dias Pereira de Sousa at 1 site in Portugal.
Trial summary
Pain in patients under hemodialysis affects chronic renal patients' quality of life. Distraction has been effective in controlling pain induced by the insertion of needles. Once applied adequately, distraction promotes endorphins' release, with efficacy in acute pain. Read more about this study
- Who is it for?
- Ages 62 to 77 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Dialysis
- What is being tested?
- Distraction technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jul 2022to 15 Sep 2022
- 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 62 to 77 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults over 18 years old
- able to read and write
- vascular access by a fistula or arteriovenous prosthesis, cannulated with a 15G needle
- vascular access at least with month old
Who cannot join
- patients under 18 years
- can't be able to read and/or write
- usage of topical anesthetics before treatment
- vascular access by a fistula or arteriovenous prosthesis, cannulated with smaller or larger 15G needles
- vascular access under one-month-old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Perception by the Chronic Renal Patient at the Time of Vascular Access Cannulation - a Randomized Trial
Pain in patients under hemodialysis affects chronic renal patients' quality of life. Distraction has been effective in controlling pain induced by the insertion of needles. Once applied adequately, distraction promotes endorphins' release, with efficacy in acute pain. This study aims to evaluate pain perception while puncturing the hemodialysis device using an anti-stress ball as a distraction strategy.
- Conditions
- Renal Dialysis
- Being tested
- Distraction technique
- Keywords
- Arteriovenous Fistula, Renal Insufficiency Chronic, Quality of Life, Distraction
- Medical subject headings
- Arteriovenous Fistula, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distraction techniqueBehavioural
Distribution of an anti-stress ball before the moment of cannulation of the vascular access and instructing to place it in hand opposite the limb of the vascular access
| Study group | Role | What they receive |
|---|---|---|
| Distraction technique | Experimental | Not described Receives: Behavioral: Distraction technique |
| Pain monitor | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain perception by hemodialysis patients
Assess the perceived pain by chronic kidney disease patients at the time of vascular access cannulation for hemodialysis, by a pain scale. On the intervention group was used a distraction technique, using an anti-stress ball, at weeks 7-12. On the control group there was only the measurement of pain by scale.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Jul 2022
- Primary completion1 Jul 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal DialysisStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joana Sofia Dias Pereira de Sousa
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Politécnico de Leiria
- Responsible party
- Sponsor-investigator, Joana Sofia Dias Pereira de Sousa, Instituto Politécnico de Leiria
- Investigators
- Joana P Sousa, PhD, Principal investigator, Instituto Politécnico de Leiria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729113
- Sponsor's protocol ID
- Pain perception
- Status last verified
- Feb 2023
- First submitted
- 24 Jan 2023
- Last updated
- 15 Feb 2023
- 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 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Perception by the Chronic Renal Patient at the Time of Vascular Access Cannulation - a Randomized Trial
- ClinicalTrials.gov ID
- NCT05729113
- Acronym / sponsor ID
- Pain perception
- Conditions
- Renal Dialysis
- Keywords
- Arteriovenous Fistula, Renal Insufficiency Chronic, Quality of Life, Distraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Joana Sofia Dias Pereira de SousaUniversity, hospital or other
- Collaborators
- Instituto Politécnico de Leiria
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 15 Feb 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.
Pain in patients under hemodialysis affects chronic renal patients' quality of life. Distraction has been effective in controlling pain induced by the insertion of needles. Once applied adequately, distraction promotes endorphins' release, with efficacy in acute pain. This study aims to evaluate pain perception while puncturing the hemodialysis device using an anti-stress ball as a distraction strategy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Distraction technique | Experimental | Behavioral: Distraction technique |
| Pain monitor | No intervention | – |
Who may qualify
- Ages
- 62 to 77 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults over 18 years old
- able to read and write
- vascular access by a fistula or arteriovenous prosthesis, cannulated with a 15G needle
- vascular access at least with month old
Key exclusion criteria (5 listed)
- patients under 18 years
- can't be able to read and/or write
- usage of topical anesthetics before treatment
- vascular access by a fistula or arteriovenous prosthesis, cannulated with smaller or larger 15G needles
- vascular access under one-month-old
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 |
|---|---|---|
| Distraction techniqueDistribution of an anti-stress ball before the moment of cannulation of the vascular access and instructing to place it in hand opposite the limb of the vascular access | Behavioural | Distraction technique |
Primary outcome
Pain perception by hemodialysis patients
Time frame: 12 weeks
Assess the perceived pain by chronic kidney disease patients at the time of vascular access cannulation for hemodialysis, by a pain scale. On the intervention group was used a distraction technique, using an anti-stress ball, at weeks 7-12. On the control group there was only the measurement of pain by scale.
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 15 Feb 2023.
- 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. This study is not recruiting at the moment.
Joana P Sousa, PhD principal investigator
Instituto Politécnico de Leiria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distraction technique in people with Renal Dialysis, run by Joana Sofia Dias Pereira de Sousa at 1 site in Portugal.
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 4 inclusion and 5 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 15 Feb 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 Portugal. 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 perception by hemodialysis patients (time frame: 12 weeks). 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 15 Feb 2023.