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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05119816
Other study ID # 0033297/06/05/2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2020
Est. completion date March 31, 2022

Study information

Verified date July 2022
Source Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date March 31, 2022
Est. primary completion date January 25, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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


Intervention

Other:
music therapy intervention
Received a customize playlists prepared by a certified music therapist to listening to during KB

Locations

Country Name City State
Italy AOUConsorziale Policlinico Di Bari Bari

Sponsors (1)

Lead Sponsor Collaborator
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 30 minutes before biopsy
Primary 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 1 hour after biopsy
Primary 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.
through study completion - 5 minutes after biopsy
Secondary 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. during biopsy procedure
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