The Effect Nature Sounds and Music on Hemodialysis Patients

Study Overview
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Brief Summary
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The study was conducted as a randomized controlled experimental research to examine the effect of nature sounds and music on vital signs and anxiety levels of hemodialysis patients. The study was conducted between September 6, 2019 and March 21, 2020 with 75 patients who received treatment in the hemodialysis units of three hospitals, one university, one education research and one state hospital in Antalya province, met the inclusion criteria and consented to participate in the study. Patients were homogenously divided into intervention (nature sound group n=25 and music group n=25) and control (n=25) groups on the basis of age, gender and hemodialysis duration. Patients in the intervention group were subjected to nature sounds/music during the hemodialysis procedure, while patients in the control group were not subjected to any intervention during the procedure. The data were collected by face-to-face interview technique using the Descriptive Characteristics Form, Vital Signs Monitoring Form, State Anxiety Inventory and Trait Anxiety Inventory. Ethics committee approval, institutional permissions and written consent of the patients were obtained for the implementation of the study. Number, percentage, mean, standard deviation, minimum and maximum, the the Shapiro Wilk normality test, One-Way Analysis of Variance, Chi-Square tests, the Kruskal Wallis test, Dunn-Bonferroni test, Tukey HSD, Three-Way Analysis of Variance and Bonferroni Corrected Two Ratio Z test were employed in the evaluation of the data.

Official Title
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The Effect of Nature Sounds and Music on Vital Signs and Anxiety Levels of Hemodialysis Patients

Conditions
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Hemodialysis Complication, Anxiety

Intervention / Treatment
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* Behavioral: Nature sounds


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteering to participate in the study Age range between 18 and 79, Receiving HD treatment for at least six months, Receiving three sessions of HD treatment per week on a regular outpatient basis at the same institution. Exclusion Criteria: Any problem that prevents cognitive, affective and verbal communication, Having any psychiatric condition, Use of anxiolytic medication, Out of the criteria for inclusion in the study,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Assigned Interventions<br>It was explained to the patients in the nature sounds group that nature sounds would be played for 30 minutes in three HD sessions for one week, starting from the beginning of the session. Afterwards, the patients were informed about the usage of the Mp3 player and in-ear headphones, they were demonstrated that they could adjust the volume to the level they desired, and it was stated that they should not detach the headphones until the 30-minute recording was over. The patients listened to nature sounds for 30 minutes in three HD sessions for one week under the supervision of the researcher. | Behavioral: Nature sounds<br>* Nature sounds would be played for 30 minutes in three HD sessions for one week, starting from the beginning of the session. Afterwards, the patients were informed about the usage of the Mp3 player and in-ear headphones, they were demonstrated that they could adjust the volume to the level they desired, and it was stated that they should not detach the headphones until the 30-minute recording was over.<br>* Other names: music;|
| No Intervention: Control Group<br>Patients in the control group were not intervened by the researcher during the HD sessions. Before the first HD session started, the Descriptive Characteristics Form and Trait Anxiety Scale were performed by the researcher while the patients were in the waiting room. Then, in every three HD sessions for one week, when the patients went to their beds, their vital signs were measured and recorded on the Vital Signs Monitoring Form and the State Anxiety Scale was administered just before the HD treatment session was started. Then, the vital signs of the patients were measured and recorded on the Vital Signs Monitoring Form at the 30th minute, 1st, 2nd, 3rd hour of the HD session and immediately after the end of the HD session. At the same time, the State Anxiety Scale was performed again immediately after the end of the HD session. The patient was then transferred out of the unit. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State Anxiety Scale (SAS) | State Anxiety Scale (SAS) is used to determine how an individual feels at a certain moment and under certain conditions. According to the degree of severity of the emotions, thoughts or behaviors expressed by the items, not at all (1), a little (2), a lot (3), completely (4) in the scale. Some of the items in the scale are direct statements and some of them are reversed statements. | Change in anxiety score during Nature Sounds and Music, an average of 10 minutes | 
| The Trait Anxiety Scale (TAS) | The Trait Anxiety Scale (TAS) is used to determine how the individual usually perceives themselves. The items are scored as almost never (1), sometimes (2), very often (3) and almost always (4) according to the frequency of the feelings, thoughts or behaviors expressed by the items. The items in the scale are in the form of direct and inverted statements. | Change in anxiety score during Nature Sounds and Music, an average of 10 minutes |