Clinical trial NCT05980845: The Effect Nature Sounds and Music on Hemodialysis Patients
Official title: The Effect of Nature Sounds and Music on Vital Signs and Anxiety Levels of Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis Complication
Anxiety
Lead sponsor: Mehmet Akif Ersoy University
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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,

Primary outcomes:
measure: State Anxiety Scale (SAS)
timeFrame: Change in anxiety score during Nature Sounds and Music, an average of 10 minutes
measure: The Trait Anxiety Scale (TAS)
timeFrame: Change in anxiety score during Nature Sounds and Music, an average of 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Burdur
country: Turkey
facility: Burdur Mehmet Akif Ersoy University
Study officials:
References:
citation: Hagemann PMS, Martin LC, Neme CMB. The effect of music therapy on hemodialysis patients' quality of life and depression symptoms. J Bras Nefrol. 2019 Jan-Mar;41(1):74-82. doi: 10.1590/2175-8239-jbn-2018-0023. Epub 2018 Sep 13.
citation: Kim Y, Evangelista LS, Park YG. Anxiolytic Effects of Music Interventions in Patients Receiving Incenter Hemodialysis: A Systematic Review and Meta-Analysis. Nephrol Nurs J. 2015 Jul-Aug;42(4):339-47; quiz 348.