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Music Therapy Intervention During Kidney Biopsy. (MTI-KB)

Primary Purpose

Kidney Diseases, Kidney Dysfunction, Kidney Disease, Chronic

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
music therapy intervention
Sponsored by
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Kidney Diseases focused on measuring music therapy, anxiety, pain, heart rate variability, satisfation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AOUConsorziale Policlinico Di Bari

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

music therapy group

Control group

Arm Description

Patients receive an individual intervention of receptive music therapy during biopsy

Patients receive standard care

Outcomes

Primary Outcome Measures

State Trait Anxiety Inventory Y-1
State Trait Anxiety Inventory Y-1(STAI-Y1) was used to measure how the subject felt in that moment. Subjects were asked to rate the intensity of their anxious feelings on 20 items on a four point scale: not at all, somewhat, moderately so, or very much so. STAI-Y values <40 defined absence of anxiety, between 40 and 50 mild anxiety, 51-60 moderate anxiety, and> 59 severe anxiety. T0 30 minutes before biopsy
State Trait Anxiety Inventory Y-1
State Trait Anxiety Inventory Y-1(STAI-Y1) was used to measure how the subject felt in that moment. Subjects were asked to rate the intensity of their anxious feelings on 20 items on a four point scale: not at all, somewhat, moderately so, or very much so. STAI-Y values <40 defined absence of anxiety, between 40 and 50 mild anxiety, 51-60 moderate anxiety, and> 59 severe anxiety. T1 1 hour after biopsy
visual analogic scale (VAS)
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.

Secondary Outcome Measures

heart rate variability
Heart rate variability (HRV) is a non-invasive measure reflecting the variation over time of the period between consecutive heartbeats (RR intervals) and has been proved to be a reliable marker of the autonomic nervous system(ANS) activity.

Full Information

First Posted
November 4, 2021
Last Updated
July 19, 2022
Sponsor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
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1. Study Identification

Unique Protocol Identification Number
NCT05119816
Brief Title
Music Therapy Intervention During Kidney Biopsy.
Acronym
MTI-KB
Official Title
Effect of Music Therapy Intervention on Heart Rate, Anxiety and Pain During Kidney Biopsy: a Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
January 25, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases, Kidney Dysfunction, Kidney Disease, Chronic
Keywords
music therapy, anxiety, pain, heart rate variability, satisfation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
music therapy group
Arm Type
Experimental
Arm Description
Patients receive an individual intervention of receptive music therapy during biopsy
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients receive standard care
Intervention Type
Other
Intervention Name(s)
music therapy intervention
Intervention Description
Received a customize playlists prepared by a certified music therapist to listening to during KB
Primary Outcome Measure Information:
Title
State Trait Anxiety Inventory Y-1
Description
State Trait Anxiety Inventory Y-1(STAI-Y1) was used to measure how the subject felt in that moment. Subjects were asked to rate the intensity of their anxious feelings on 20 items on a four point scale: not at all, somewhat, moderately so, or very much so. STAI-Y values <40 defined absence of anxiety, between 40 and 50 mild anxiety, 51-60 moderate anxiety, and> 59 severe anxiety. T0 30 minutes before biopsy
Time Frame
30 minutes before biopsy
Title
State Trait Anxiety Inventory Y-1
Description
State Trait Anxiety Inventory Y-1(STAI-Y1) was used to measure how the subject felt in that moment. Subjects were asked to rate the intensity of their anxious feelings on 20 items on a four point scale: not at all, somewhat, moderately so, or very much so. STAI-Y values <40 defined absence of anxiety, between 40 and 50 mild anxiety, 51-60 moderate anxiety, and> 59 severe anxiety. T1 1 hour after biopsy
Time Frame
1 hour after biopsy
Title
visual analogic scale (VAS)
Description
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.
Time Frame
through study completion - 5 minutes after biopsy
Secondary Outcome Measure Information:
Title
heart rate variability
Description
Heart rate variability (HRV) is a non-invasive measure reflecting the variation over time of the period between consecutive heartbeats (RR intervals) and has been proved to be a reliable marker of the autonomic nervous system(ANS) activity.
Time Frame
during biopsy procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
AOUConsorziale Policlinico Di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Music Therapy Intervention During Kidney Biopsy.

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