MTI-KB: Music Therapy Intervention During Kidney Biopsy.

Sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari (Other)

Overall Status

Completed

CT.gov ID

NCT05119816

Collaborator

(none)

120

Enrollment

Location

Arms

21.9

Actual Duration (Months)

5.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Diseases Kidney Dysfunction Kidney Disease, Chronic	Other: music therapy intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Effect of Music Therapy Intervention on Heart Rate, Anxiety and Pain During Kidney Biopsy: a Randomized Controlled Trial.

Actual Study Start Date :

Jun 1, 2020

Actual Primary Completion Date :

Jan 25, 2022

Actual Study Completion Date :

Mar 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: music therapy group Patients receive an individual intervention of receptive music therapy during biopsy	Other: music therapy intervention Received a customize playlists prepared by a certified music therapist to listening to during KB
No Intervention: Control group Patients receive standard care

Arm

Intervention/Treatment

Experimental: music therapy group

Patients receive an individual intervention of receptive music therapy during biopsy

Other: music therapy intervention

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

No Intervention: Control group

Patients receive standard care

Outcome Measures

Primary Outcome Measures

State Trait Anxiety Inventory Y-1 [30 minutes before biopsy]
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 [1 hour after biopsy]
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) [through study completion - 5 minutes after biopsy]
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 [during biopsy procedure]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AOUConsorziale Policlinico Di Bari	Bari		Italy	70124

Sponsors and Collaborators

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Loreto Gesualdo, MD, professor, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

ClinicalTrials.gov Identifier:

NCT05119816

Other Study ID Numbers:

0033297/06/05/2020

First Posted:

Nov 15, 2021

Last Update Posted:

Jul 20, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Loreto Gesualdo, MD, professor, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

music therapy

anxiety

pain

heart rate variability

satisfation

Additional relevant MeSH terms:

Kidney Diseases

Renal Insufficiency, Chronic

Study Results

No Results Posted as of Jul 20, 2022