Music Therapy Intervention During Kidney Biopsy.

Study Overview
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Brief Summary
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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.

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

Conditions
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Kidney Diseases, Kidney Dysfunction, Kidney Disease, Chronic

Intervention / Treatment
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* Other: music therapy intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: music therapy group<br>Patients receive an individual intervention of receptive music therapy during biopsy | Other: music therapy intervention<br>* Received a customize playlists prepared by a certified music therapist to listening to during KB<br>|
| No Intervention: Control group<br>Patients receive standard care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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music therapy, anxiety, pain, heart rate variability, satisfation