NCT06314854

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2024

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2024

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

March 11, 2024

Last Update Submit

April 27, 2024

Conditions

Keywords

anxietypain

Outcome Measures

Primary Outcomes (1)

  • Pain Assessment

    VAS

    nearly 40 days

Secondary Outcomes (1)

  • State and Trait Anxiety Assessment

    nearly 40 days

Study Arms (2)

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.

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.

Interventions

Running water sound for experimental group Standard care for control group

Experimental Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • between 18 - 65 years
  • not have communication problem
  • Patients receiving dialysis 3 days a week
  • Have cannulation

You may not qualify if:

  • under 18- over 65 years
  • Have communication problems
  • Not have dialysis 3 days a week
  • Have not cannulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aas

Kırklareli, Center, 39000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersPain

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 11, 2024

First Posted

March 18, 2024

Study Start

December 15, 2023

Primary Completion

March 15, 2024

Study Completion

March 15, 2024

Last Updated

April 30, 2024

Record last verified: 2024-04

Locations