Hemodialysis PatientsNCT05574595
Effect on Pain and Comfort Associated With Fistula Puncture
A study testing Music theraphy in people with Hemodialysis Patients, run by Kırklareli University.
Trial summary
Purpose This study was carried out as the design of the targeted design in terms of targeting and comfort in the patient with hemodialysis. Material and Methods: It was successfully tested both in the control team of a hospital at the point of sale in Turkey and with experience. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodialysis Patients
- What is being tested?
- Music theraphy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2022to 15 Nov 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be volunteering,
- 18 years or older,
- receiving hemodialysis treatment for at least 6 months
- not any hearing problem.
Who cannot join
- have hearing problem
- not be volunteering.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Self-selected Soothing Music on Fistula Puncture-related Pain and Comfort in Hemodialysis Patients
Purpose This study was carried out as the design of the targeted design in terms of targeting and comfort in the patient with hemodialysis.
Material and Methods: It was successfully tested both in the control team of a hospital at the point of sale in Turkey and with experience. By block randomization method to randomize. Data were collected with "Patient identification formula", "Visual Analog Scale (VAS)" and "Hemodialysis Comfort Scale". Independent sample t-test was used in the analysis of the data, analysis of variance in repeated measurements and Cohen'd was used to calculate the size.
Read the detailed description
It is appropriate to suggest a non-pharmacological rather clinical rather than a literature-free method, al. Also, due to the fact that the duration of anesthetic effect will expire from the dialysis treatment used (Subramanian et al., 2012).
Participant's care continues for inappropriate pain management. This quality standard is one of the criteria of a standard rather than a preference for a simple, reliable and inexpensive non-pharmacological choice.
As far as investigators know, there are very few studies investigating the effect of a patient's choice of music on pain following insertion of a needle into a fistula in hemodialysis patients. More focused on non-pharmacological types such as pharmacological and aromatherapy. Therefore, the aim of this study was to examine the effect of the type of music chosen by hemodialysis patients on pain and comfort associated with fistula puncture.
- Conditions
- Hemodialysis Patients
- Being tested
- Music theraphy
- Keywords
- pain, comfort
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music theraphyOther
Also called There is no other name.
In each session, the desired type of music will be played approximately 6 minutes before the procedure (Shabandokht-Zarmi et al., 2017). After the end of the music, the cannulation process will be performed by the dialysis nurse. The level of pain experienced by the patient immediately after needle insertion into the fistula will be evaluated with VAS by a research-independent nurse working in the dialysis unit.
| Study group | Role | What they receive |
|---|---|---|
| The Mean of the Hemodialysis Comfort Scale scores of the experimental and group patients | Experimental | To the Experimental Group; The information form and the short form of the comfort scale will be applied to the patient who is taken to the dialysis unit to start HD treatment. Receives: Other: Music theraphy |
| The mean of the Hemodialysis Comfort Scale scores of the control group patients | No intervention | No procedure was performed on the patients in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Efficacy of Music on Pain Level
Visual Analog Scale
Measured: 7 days
Secondary outcomes (1)
The Efficacy of Music on Comfort Level
Comfort Scale
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start15 Oct 2022 (estimated)
- Primary completion15 Oct 2022 (estimated)
- Study completion15 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis PatientsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aylin Aydin Sayilan, Kırklareli University
- Investigators
- Nurşen KULAKAÇ, pHD, Principal investigator, Gümüşhane Universıty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574595
- Sponsor's protocol ID
- 2022/4
- Status last verified
- Oct 2022
- First submitted
- 5 Oct 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sayilan S, Sayilan AA, Kulakac N. The effect of self-selected soothing music on fistula puncture-related pain and comfort levels in hemodialysis patients: a randomized controlled, single-blind, single-center study. Int Urol Nephrol. 2026 May;58(5):1839-1847. doi: 10.1007/s11255-025-04877-5. Epub 2025 Oct 28.
PubMed 41148531
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Self-selected Soothing Music on Fistula Puncture-related Pain and Comfort in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05574595
- Acronym / sponsor ID
- 2022/4
- Conditions
- Hemodialysis Patients
- Keywords
- pain, comfort
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Study start
- 15 Oct 2022 (estimated)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 15 Nov 2022 (estimated)
- First posted
- 10 Oct 2022 (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.
Purpose This study was carried out as the design of the targeted design in terms of targeting and comfort in the patient with hemodialysis.
Material and Methods: It was successfully tested both in the control team of a hospital at the point of sale in Turkey and with experience. By block randomization method to randomize. Data were collected with "Patient identification formula", "Visual Analog Scale (VAS)" and "Hemodialysis Comfort Scale". Independent sample t-test was used in the analysis of the data, analysis of variance in repeated measurements and Cohen'd was used to calculate the size.
Detailed description
It is appropriate to suggest a non-pharmacological rather clinical rather than a literature-free method, al. Also, due to the fact that the duration of anesthetic effect will expire from the dialysis treatment used (Subramanian et al., 2012).
Participant's care continues for inappropriate pain management. This quality standard is one of the criteria of a standard rather than a preference for a simple, reliable and inexpensive non-pharmacological choice.
As far as investigators know, there are very few studies investigating the effect of a patient's choice of music on pain following insertion of a needle into a fistula in hemodialysis patients. More focused on non-pharmacological types such as pharmacological and aromatherapy. Therefore, the aim of this study was to examine the effect of the type of music chosen by hemodialysis patients on pain and comfort associated with fistula puncture.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Mean of the Hemodialysis Comfort Scale scores of the experimental and group patients | Experimental | Other: Music theraphyTo the Experimental Group; The information form and the short form of the comfort scale will be applied to the patient who is taken to the dialysis unit to start HD treatment. |
| The mean of the Hemodialysis Comfort Scale scores of the control group patients | No intervention | –No procedure was performed on the patients in the control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- be volunteering,
- 18 years or older,
- receiving hemodialysis treatment for at least 6 months
- not any hearing problem.
Key exclusion criteria (2 listed)
- have hearing problem
- not be volunteering.
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 |
|---|---|---|
| Music theraphyAlso: There is no other name.In each session, the desired type of music will be played approximately 6 minutes before the procedure (Shabandokht-Zarmi et al., 2017). After the end of the music, the cannulation process will be performed by the dialysis nurse. The level of pain experienced by the patient immediately after needle insertion into the fistula will be evaluated with VAS by a research-independent nurse working in the dialysis unit. | Other | The Mean of the Hemodialysis Comfort Scale scores of the experimental and group patients |
Primary outcome
The Efficacy of Music on Pain Level
Time frame: 7 days
Visual Analog Scale
1 secondary outcome
The Efficacy of Music on Comfort Level
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Derived from this study: PubMed 41148531Sayilan S, Sayilan AA, Kulakac N. The effect of self-selected soothing music on fistula puncture-related pain and comfort levels in hemodialysis patients: a randomized controlled, single-blind, single-center study. Int Urol Nephrol. 2026 May;58(5):1839-1847. doi: 10.1007/s11255-025-04877-5. Epub 2025 Oct 28.
- 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.
Nurşen KULAKAÇ, pHD principal investigator
Gümüşhane Universıty
Questions about this trial
What is this clinical trial studying?
A study testing Music theraphy in people with Hemodialysis Patients, run by Kırklareli University.
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 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: status not confirmed, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aylin AYDIN SAYILAN, PhD (+902882145547, aylin.sayilan@klu.du.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Efficacy of Music on Pain Level (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05574595, which also lists 1 linked publication.
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 10 Oct 2022; AzTrials last refreshed its copy on 7 Nov 2026.