Nature-Based Sound Application For Hemodialysis Patients

NCT06165211 | Completed

• 2 other identifiers: Bartın Unıversity1919B012102111
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic renal failure is one of the most common chronic diseases in the world and in our country. Hemodialysis is the most commonly used treatment method in the treatment of chronic renal failure. In addition to its important benefits, hemodialysis treatment causes many problems such as fatigue, bone and joint pain, insomnia, mood disorders, sexual problems, paresthesia and nausea. In addition, patient comfort is adversely affected due to physical, psychosocial and environmental problems in hemodialysis patients. Elimination of symptoms in hemodialysis patients and ensuring patient comfort are important components of quality nursing care. For this purpose, it is reported that non-pharmacological evidence-based approaches such as listening to music, yoga, and exercise are used in the literature. Although there are studies examining the effectiveness of listening to music, the number of studies examining the effectiveness of nature-based sounds in hemodialysis patients is quite limited. It is known that sounds such as bird, ocean, water, wind sound have beneficial effects on human health in terms of physiological and psychosocial aspects. This project is to determine the effect of listening to nature sounds during hemodialysis treatment on fatigue and patient comfort. Type of Study: The project was planned as a randomized controlled experimental study. Population and Sample: The population of the study consists of patients who are treated in the Hemodialysis Unit of Bartin State Hospital. The sample was taken as d=0.80 power=0.90, α=0.05 and β=0.20, taking into account the data obtained from a similar study, and it was calculated as 30 patients in the intervention group and 30 patients in the control group, in total 60 patients. Inclusion criteria for the study:

• To be receiving hemodialysis treatment for at least 6 months,
• Being over 18 years old,
• Not having a hearing and speaking disability,
• Not have a cognitive disability. Exclusion criteria from the study:
• Receiving hemodialysis treatment for less than 6 months,
• Do not listen to the nature-based audio application for 30 minutes
• Being under the age of 18,
• Hearing and speech impairment,
• Having a cognitive disability.

Conditions

Chronic Kidney Failure; Hemodialysis Patients; Fatigue; Patient Comfort; Nature Sounds

Outcome Measures

Primary Outcomes (2)

• Piper Fatigue Scale Score

  The scale consists of a total of 4 sub-dimensions and 22 items, including the behavioral sub-dimension (6 items), the affective sub-dimension (5 items), the sensory sub-dimension (5 items), and the cognitive sub-dimension (6 items). Subscale scores and total fatigue scores are calculated using these 22 items. The other 5 items are used to calculate the subscales or the total fatigue score. There are three open-ended questions to indicate the reason for fatigue. In order to calculate the score of the scale, the average score obtained from the scale is calculated by adding all the scores of 22 items and dividing them by the number of items.

  pre-intervention

• Hemodialysis Comfort Scale Score

  The scale consists of a total of 9 items and two sub-dimensions: relaxation and overcoming. The total score evaluation of the scale and its sub-dimensions is determined by calculating the average score.

  pre-intervention

Secondary Outcomes (2)

• Piper Fatigue Scale Score

  immediately after the intervention

• Hemodialysis Comfort Scale Score

  immediately after the intervention

Study Arms (2)

Nature Sound Group

EXPERIMENTAL

During hemodialysis, 30 minutes with an Mp3 player and headphones (to minimize the effect of surrounding noise). Nature sounds consisting of bird, wind and tree sounds will be played.

Other: Nature sound listening

Routine Care

PLACEBO COMPARATOR

Patients will watch the program they want on the bedside TV during hemodialysis.

Other: Routine care

Interventions

Nature sound listening OTHER

The intervention group listened to nature sounds for 30 minutes during hemodialysis. Nature sounds consisting of bird, wind and tree sounds will be played.

Nature Sound Group

Routine care OTHER

Patients will watch the program they want on the bedside TV during hemodialysis.

Routine Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be receiving hemodialysis treatment for at least 6 months,
• Being over 18 years old,
• Not having a hearing and speaking disability,
• Not have a cognitive disability.

You may not qualify if:

• Receiving hemodialysis treatment for less than 6 months,
• Being under the age of 18,
• Hearing and speech impairment,
• Having a cognitive disability.

Sponsors & Collaborators

• Necmiye ÇÖMLEKÇİ: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Necmiye ÇÖMLEKÇİ

Bartın, 74100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Fatigue

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Necmiye ÇÖMLEKÇİ

  Bartın Unıversity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: December 11, 2023
• Study Start: September 15, 2022
• Primary Completion: February 20, 2023
• Study Completion: February 20, 2023
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared immediately after the research article is published.
• Access Criteria: Data will be shared for secondary analyzes and meta-analysis studies.

Locations

TU (1)