Music Therapy Intervention During Kidney Biopsy.

NCT ID: NCT05119816

Last Updated: 2022-07-20

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2022-03-31

Brief Summary

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Kidney biopsy (KB) is an invasive procedure that is very useful in diagnosing kidney disease in both the native kidney and the transplanted kidney. Patients undergo KB can feel anxiety and pain. Pain is considered one of the worst experiences for patients and anxiety affects the sympathetic nervous system, the endocrine system and the immune system. The aim of this preliminary study was to evaluate the influence of MTI as a complementary/nonpharmacological intervention on heart rate variability, anxiety and pain and promote more compliant behaviours during KB.

Detailed Description

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Conditions

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Kidney Diseases Kidney Dysfunction Kidney Disease, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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music therapy group

Patients receive an individual intervention of receptive music therapy during biopsy

Group Type EXPERIMENTAL

music therapy intervention

Intervention Type OTHER

Received a customize playlists prepared by a certified music therapist to listening to during KB

Control group

Patients receive standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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music therapy intervention

Received a customize playlists prepared by a certified music therapist to listening to during KB

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age over 18 years
* not severe neurological or psychiatric conditions
* not hearing impairment

Exclusion Criteria

* age under 18 years
* severe neurological or psychiatric conditions
* hearing impairment
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

OTHER

Sponsor Role lead

Responsible Party

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Loreto Gesualdo, MD

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AOUConsorziale Policlinico Di Bari

Bari, , Italy

Site Status

Countries

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Italy

Other Identifiers

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0033297/06/05/2020

Identifier Type: -

Identifier Source: org_study_id

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