Music Therapy Intervention During Kidney Biopsy.

Not Applicable

Completed

• Conditions: Kidney Diseases; Kidney Disease, Chronic; Kidney Dysfunction
• Interventions: Other: music therapy intervention

• Registration Number: NCT05119816
• Lead Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2021-11-04
• Study First Submitted QC: 2021-11-12
• Study First Posted: 2021-11-15
• Primary Completion: 2022-01-25
• Study Completion: 2022-03-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
music therapy group	music therapy intervention	Patients receive an individual intervention of receptive music therapy during biopsy

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

AOUConsorziale Policlinico Di Bari; 🇮🇹 Bari, Italy