Skip to main content
OpenTrials
Completed

NCT Number: NCT05119816

Music Therapy Intervention During Kidney Biopsy.

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

music therapy intervention

Other

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

Primary outcomes

  1. State Trait Anxiety Inventory Y-1

    Time frame: 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

  2. State Trait Anxiety Inventory Y-1

    Time frame: 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

  3. visual analogic scale (VAS)

    Time frame: 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 outcomes

  1. heart rate variability

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Other

Registry information

Official study title

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

Acronym: MTI-KB

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 15, 2021
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.