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Clinical Trials/NCT05980845
NCT05980845
Completed
Not Applicable

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

Mehmet Akif Ersoy University1 site in 1 country50 target enrollmentSeptember 6, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemodialysis Complication
Sponsor
Mehmet Akif Ersoy University
Enrollment
50
Locations
1
Primary Endpoint
State Anxiety Scale (SAS)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 6, 2019
End Date
July 8, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Mehmet Akif Ersoy University
Responsible Party
Principal Investigator
Principal Investigator

IMarasli

Principal Investigator

Mehmet Akif Ersoy University

Eligibility Criteria

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,

Outcomes

Primary Outcomes

State Anxiety Scale (SAS)

Time Frame: Change in anxiety score during Nature Sounds and Music, an average of 10 minutes

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.

The Trait Anxiety Scale (TAS)

Time Frame: Change in anxiety score during Nature Sounds and Music, an average of 10 minutes

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.

Study Sites (1)

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