Skip to content

Music Therapy Intervention During Kidney Biopsy.

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05119816
Acronym
MTI-KB
Enrollment
120
Registered
2021-11-15
Start date
2020-06-01
Completion date
2022-03-31
Last updated
2022-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Disease, Chronic, Kidney Diseases, Kidney Dysfunction

Keywords

music therapy, anxiety, pain, heart rate variability, satisfation

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.

Interventions

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

Sponsors

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
State Trait Anxiety Inventory Y-130 minutes before biopsyState 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
visual analogic scale (VAS)through study completion - 5 minutes after biopsyA 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

MeasureTime frameDescription
heart rate variabilityduring biopsy procedureHeart 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026