The Effect of Running Water Sound Listened to Patients During Hemodialysis

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.

Study Overview

• Status: Completed
• Conditions: Hemodialysis Patients
• Intervention / Treatment: Other: Running water sound

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Center
    • Kırklareli, Center, Turkey, 39000
      • Aas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; 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; Running water sound for experimental group Standard care for control group
No Intervention: Control Group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Assessment	VAS	nearly 40 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
State and Trait Anxiety Assessment	STAI I AND STAI II	nearly 40 days

Collaborators and Investigators

• Sponsor: Kırklareli University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2023
• Primary Completion (Actual): March 15, 2024
• Study Completion (Actual): March 15, 2024

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 27, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: pain; anxiety
• Other Study ID Numbers: P202300046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No