The Effect of Running Water Sound Listened to Patients During Hemodialysis

NCT ID: NCT06314854

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-15
• Study Completion Date: 2024-03-15

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Running water sound

Intervention Type: OTHER

Running water sound for experimental group Standard care for control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Running water sound

Running water sound for experimental group Standard care for control group

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kırklareli University

OTHER

Sponsor Role: lead

Responsible Party

Aylin Aydin Sayilan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aas

Kırklareli, Center, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

P202300046

Identifier Type: -

Identifier Source: org_study_id