Nature-Based Sound Application For Hemodialysis Patients

NCT ID: NCT06165211

Last Updated: 2024-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-15
• Study Completion Date: 2023-02-20

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.

Detailed Description

Data Collection Tools: Data will be collected using the Descriptive Information Form, Piper Fatigue Scale and Hemodialysis Patients Comfort Scale.

Descriptive Information Form: In this form, there are 15 questions created in line with the literature. It consists of two sections containing socio-demographic characteristics and disease information.

Piper Fatigue Scale (PFA): Piper et al. It was developed by in 1998. The scale consists of a total of 4 sub-dimensions and 22 items: behavioral sub-dimension (6 items), affective sub-dimension (5 items), emotional sub-dimension (5 items) and 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 total fatigue score. There are three open-ended questions to indicate the cause of fatigue. To calculate the score of the scale, the average score obtained from the scale is calculated by adding up all the scores of the 22 items and dividing by the number of items.

Hemodialysis Comfort Scale (HDCS): Hemodialysis Comfort Scale Orak et al. It was developed to determine the comfort levels of hemodialysis patients. The scale consists of a total of 9 items and two subscales: relaxation and coping. The total score evaluation of the scale and its sub-dimensions is determined by calculating the average score. Cronbach's alpha value of the scale was found to be 0.87.

Data Collection Process: The researcher will collect data in Bartin State Hospital Hemodialysis Unit and fill out the surveys using the interview method. while the patients are during the dialysis session in an average of 30-45 minutes. After the patients registered to the dialysis center are randomized by block randomization method as intervention and control groups, the Patient Diagnosis Form and pre-test (Piper Fatigue Scale and Hemodialysis Comfort Scale) will be applied to the patients before the hemodialysis session. Afterwards, during hemodialysis, listen with an Mp3 player and headphones (to minimize the effect of surrounding noise) for 30 minutes. Nature sounds will be played. After the hemodialysis session is completed, the patients will be given a posttest (Piper Fatigue Scale and Hemodialysis Comfort Scale) by the researcher.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Nature Sound Group

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.

Group Type: EXPERIMENTAL

Nature sound listening

Intervention Type: 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.

Routine Care

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

Group Type: PLACEBO_COMPARATOR

Routine care

Intervention Type: OTHER

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

Interventions

Nature sound listening

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

Intervention Type: OTHER

Routine care

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role: collaborator

Necmiye ÇÖMLEKÇİ

OTHER

Sponsor Role: lead

Responsible Party

Necmiye ÇÖMLEKÇİ

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Necmiye ÇÖMLEKÇİ

Role: PRINCIPAL_INVESTIGATOR

Bartın Unıversity

Locations

Necmiye ÇÖMLEKÇİ

Bartın, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

1919B012102111

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Bartın Unıversity

Identifier Type: -

Identifier Source: org_study_id