The Effect Nature Sounds and Music on Hemodialysis Patients

Sponsor
Mehmet Akif Ersoy University (Other)
Overall Status
Completed
CT.gov ID
NCT05980845
Collaborator
(none)
50
1
2
46
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Nature sounds
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Nature Sounds and Music on Vital Signs and Anxiety Levels of Hemodialysis Patients
Actual Study Start Date :
Sep 6, 2019
Actual Primary Completion Date :
Mar 21, 2020
Actual Study Completion Date :
Jul 8, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Assigned Interventions

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
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.
Other Names:
  • music
  • No Intervention: Control Group

    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.

    Outcome Measures

    Primary Outcome Measures

    1. State Anxiety Scale (SAS) [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.

    2. The Trait Anxiety Scale (TAS) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 79 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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,

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Burdur Mehmet Akif Ersoy University Burdur Turkey 15000

    Sponsors and Collaborators

    • Mehmet Akif Ersoy University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    IMarasli, Principal Investigator, Mehmet Akif Ersoy University
    ClinicalTrials.gov Identifier:
    NCT05980845
    Other Study ID Numbers:
    • 12.09.2018-4
    First Posted:
    Aug 8, 2023
    Last Update Posted:
    Aug 8, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 8, 2023