Music Therapy Intervention During Kidney Biopsy.

NCT05119816 | Completed

• 1 other identifier: 0033297/06/05/2020
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Diseases; Kidney Dysfunction; Kidney Disease, Chronic

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• heart rate variability

  during biopsy procedure

Study Arms (2)

music therapy group

EXPERIMENTAL

Patients receive an individual intervention of receptive music therapy during biopsy

Other: music therapy intervention

Control group

NO INTERVENTION

Patients receive standard care

Interventions

music therapy intervention OTHER

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

music therapy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age over 18 years
• not severe neurological or psychiatric conditions
• not hearing impairment

You may not qualify if:

• age under 18 years
• severe neurological or psychiatric conditions
• hearing impairment

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: lead

Study Sites (1)

AOUConsorziale Policlinico Di Bari

Bari, 70124, Italy

Location

MeSH Terms

Conditions

Kidney Diseases; Renal Insufficiency, Chronic; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 15, 2021
• Study Start: June 1, 2020
• Primary Completion: January 25, 2022
• Study Completion: March 31, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)