Hemodialysis PatientsNCT06314854
The Effect of Running Water Sound Listened to Patients During Hemodialysis
A study testing Running water sound in people with Hemodialysis Patients, run by Kırklareli University at 1 site in Turkey (Türkiye).
Trial summary
It is known that being in nature and the visual perception of nature positively affects an individual's mood and self-confidence. Studies have reported that natural sounds have a positive effect in situations such as pain, anxiety, and stress. 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?
- Running water sound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2023to 15 Mar 2024
- 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
- between 18 - 65 years
- not have communication problem
- Patients receiving dialysis 3 days a week
- Have cannulation
Who cannot join
- under 18- over 65 years
- Have communication problems
- Not have dialysis 3 days a week
- Have not cannulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Running Water Sound Listened to Patients During Hemodialysis on Invasive Pain and Anxiety Experienced During Cannulation
It is known that being in nature and the visual perception of nature positively affects an individual's mood and self-confidence. Studies have reported that natural sounds have a positive effect in situations such as pain, anxiety, and stress. This finding means that listening to natural sounds may be a simple and easily accessible intervention that can positively impact key human stress systems.
Although many non-pharmacological methods are used in the literature to reduce the invasive pain and anxiety experienced by hemodialysis (HD) patients during cannulation, the most popular recently; However, we aimed to determine the effect of the sound of running water, which we have not yet encountered in dialysis patients, on invasive pain and anxiety experienced during fistula access.
Read the detailed description
In this study; Between 15 December 2023 and 15 March 2024, patients receiving dialysis will be included in the Dialysis Service of two hospitals in western of Turkey which havedialysis for 3 days a week.
The sample calculation was determined using power analysis based on a previous study. (Çetinkaya, Karabulut (2010). The sample size of the study was calculated as at least 30 patients, for each group that met the sampling criteria. The population of the research was determined as 74 people. The number of patients who met the inclusion criteria was 68, and these patients were assigned to the experimental (34 patients) and control (34 patients) groups by an independent statistician with the help of a computer program (randomizer.org).
Patients over the age of 18, who are volunteers, who undergo dialysis 3 days a week, who do not have any communication problems and who do not use any psychiatric medication will be included in the study. Patients who do not meet the inclusion criteria will be excluded from the study.
Dialysis sessions are held 3 days a week, between 08.00-16.00, on Mon-Wed-Fri and Tuesday-Thurs-Sat.
All patients who volunteer to participate in the study will be included in the study. During the cannulation process, the experimental group will listen to the sound of flowing water throughout the process with the help of the researcher's smartphone. VAS scale will be applied to the experimental and control groups after each cannulation, and the State and Trait Anxiety Scale will be applied before the first dialysis session and after the 12th session. The control group will receive standard care. A total of 12 sessions will be followed in both groups.
- Conditions
- Hemodialysis Patients
- Being tested
- Running water sound
- Keywords
- anxiety, pain
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Running water soundOther
Running water sound for experimental group Standard care for control group
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | During the cannulation process, the experimental group will listen to the sound of flowing water throughout the process through the researcher's smartphone. The experimental and control groups will be administered VAS before, during and after each cannulation, and the State and Trait Anxiety Scale will be administered before the dialysis session and after the 12th first session. Receives: Other: Running water sound |
| Control Group | No intervention | The control group will be provided with standard care and no intervention will be made. A total of 12 sessions will be followed in both groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Assessment
VAS
Measured: nearly 40 days
Secondary outcomes (1)
State and Trait Anxiety Assessment
STAI I AND STAI II
Measured: nearly 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start15 Dec 2023
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aylin Aydin Sayilan, Kırklareli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314854
- Sponsor's protocol ID
- P202300046
- Status last verified
- Apr 2024
- First submitted
- 11 Mar 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Running Water Sound Listened to Patients During Hemodialysis on Invasive Pain and Anxiety Experienced During Cannulation
- ClinicalTrials.gov ID
- NCT06314854
- Acronym / sponsor ID
- P202300046
- Conditions
- Hemodialysis Patients
- Keywords
- anxiety, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 18 Mar 2024 (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.
It is known that being in nature and the visual perception of nature positively affects an individual's mood and self-confidence. Studies have reported that natural sounds have a positive effect in situations such as pain, anxiety, and stress. This finding means that listening to natural sounds may be a simple and easily accessible intervention that can positively impact key human stress systems.
Although many non-pharmacological methods are used in the literature to reduce the invasive pain and anxiety experienced by hemodialysis (HD) patients during cannulation, the most popular recently; However, we aimed to determine the effect of the sound of running water, which we have not yet encountered in dialysis patients, on invasive pain and anxiety experienced during fistula access.
Detailed description
In this study; Between 15 December 2023 and 15 March 2024, patients receiving dialysis will be included in the Dialysis Service of two hospitals in western of Turkey which havedialysis for 3 days a week.
The sample calculation was determined using power analysis based on a previous study. (Çetinkaya, Karabulut (2010). The sample size of the study was calculated as at least 30 patients, for each group that met the sampling criteria. The population of the research was determined as 74 people. The number of patients who met the inclusion criteria was 68, and these patients were assigned to the experimental (34 patients) and control (34 patients) groups by an independent statistician with the help of a computer program (randomizer.org).
Patients over the age of 18, who are volunteers, who undergo dialysis 3 days a week, who do not have any communication problems and who do not use any psychiatric medication will be included in the study. Patients who do not meet the inclusion criteria will be excluded from the study.
Dialysis sessions are held 3 days a week, between 08.00-16.00, on Mon-Wed-Fri and Tuesday-Thurs-Sat.
All patients who volunteer to participate in the study will be included in the study. During the cannulation process, the experimental group will listen to the sound of flowing water throughout the process with the help of the researcher's smartphone. VAS scale will be applied to the experimental and control groups after each cannulation, and the State and Trait Anxiety Scale will be applied before the first dialysis session and after the 12th session. The control group will receive standard care. A total of 12 sessions will be followed in both groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Running water soundDuring the cannulation process, the experimental group will listen to the sound of flowing water throughout the process through the researcher's smartphone. The experimental and control groups will be administered VAS before, during and after each cannulation, and the State and Trait Anxiety Scale will be administered before the dialysis session and after the 12th first session. |
| Control Group | No intervention | –The control group will be provided with standard care and no intervention will be made. A total of 12 sessions will be followed in both groups. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- between 18 - 65 years
- not have communication problem
- Patients receiving dialysis 3 days a week
- Have cannulation
Key exclusion criteria (4 listed)
- under 18- over 65 years
- Have communication problems
- Not have dialysis 3 days a week
- Have not cannulation
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 |
|---|---|---|
| Running water soundRunning water sound for experimental group Standard care for control group | Other | Experimental Group |
Primary outcome
Pain Assessment
Time frame: nearly 40 days
VAS
1 secondary outcome
State and Trait Anxiety Assessment
Time frame: nearly 40 days
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 30 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Running water sound in people with Hemodialysis Patients, run by Kırklareli 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 4 inclusion and 4 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 30 Apr 2024. 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 Assessment (time frame: nearly 40 days). 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 30 Apr 2024.