The Effect Nature Sounds and Music on Hemodialysis Patients

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05980845
• Other study ID #: 12.09.2018-4
• Status: Completed
• Phase: N/A
• Start date: September 6, 2019
• Est. completion date: July 8, 2023

Study information

• Verified date: July 2023
• Source: Mehmet Akif Ersoy University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 8, 2023
• Est. primary completion date: March 21, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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,

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Hemodialysis Complication

Intervention

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.

Locations

Country	Name	City	State
Turkey	Burdur Mehmet Akif Ersoy University	Burdur

Sponsors (1)

Lead Sponsor	Collaborator
Mehmet Akif Ersoy University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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