The Effect of Running Water Sound Listened to Patients During Hemodialysis

Hemodialysis Patients Clinical Trial

Official title:

The Effect of Running Water Sound Listened to Patients During Hemodialysis on Invasive Pain and Anxiety Experienced During Cannulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06314854
• Other study ID #: P202300046
• Status: Completed
• Phase: N/A
• Start date: December 15, 2023
• Est. completion date: March 15, 2024

Study information

• Verified date: April 2024
• Source: Kirklareli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 15, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodialysis Patients

Intervention

Other:
• Running water sound
Running water sound for experimental group Standard care for control group

Locations

Country	Name	City	State
Turkey	Aas	Kirklareli	Center

Sponsors (1)

Lead Sponsor	Collaborator
Kirklareli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Assessment	VAS	nearly 40 days
Secondary	State and Trait Anxiety Assessment	STAI I AND STAI II	nearly 40 days