The Effect Nature Sounds and Music on Hemodialysis Patients

NCT ID: NCT05980845

Last Updated: 2023-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-06

Study Completion Date

2023-07-08

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.

Detailed Description

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Conditions

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Hemodialysis Complication Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Nature sounds

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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music

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,
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mehmet Akif Ersoy University

OTHER

Sponsor Role lead

Responsible Party

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IMarasli

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Burdur Mehmet Akif Ersoy University

Burdur, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 30222176 (View on PubMed)

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.

Reference Type RESULT
PMID: 26462307 (View on PubMed)

Other Identifiers

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12.09.2018-4

Identifier Type: -

Identifier Source: org_study_id

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