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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03791177
Other study ID # AksarayUTRH2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date December 29, 2018

Study information

Verified date December 2018
Source Aksaray University Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Today music acts as an analgesic and anxiolytic in a safe, cheap and simple way. Several trials have confirmed its potential administration and benefits in urology practice. We aimed to assess the influence of music therapy on perceived anxiety and pain during outpatient urodynamic study (UDS) using the Visual Analog Scale (VAS) and the State-Trait Anxiety Inventory (STAI) in a prospective, randomized fashion


Description:

Urodynamic study (UDS) is often used to help urologists to evaluate the functions of bladder and urethra in outpatient clinic.1 Although a UDS is a reliable tool for accurate diagnosis, the process itself can be accompanied by discomfort and pain as it includes the positioning the catheters urethral and rectally, and the bladder filling. Reports of having such invasive outpatient process whilst awake may demonstrate pain and disquiet that result in incomplete examinations and patient noncompliance2,3.

Various pharmacologic options including lidocaine gel and catheter tip lubrication for urethral catheterization were used to relieve pain and anxiety during UDS. Besides, there are some non-pharmalogical methods such as patient education, heating pad, music, distraction and relaxation4-6.

Music has been considered complementary treatment modality as cheap, safe and effective. In various urological procedures including cystoscopy, transrectal prostate biopsy and extracorporeal shock wave lithotripsy (ESWL) music has been proven helpful on pain and anxiety levels 7-10. However, current literature presents limited and controversial data evaluating the influence of music on pain and anxiety perspective of the patient during UDS. We, therefore, aimed to assess the effect of music on patient satisfaction in a analgesic and anxiolytic way during UDS.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date December 29, 2018
Est. primary completion date October 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

Exclusion Criteria:

Exclusion criteria included paraplegia, hearing impairment, taking any analgesic or anxiolytic drug to suppress the symptoms of anxiety until 24 hours prior to UDS, inability to understand or fulfill commands during UDS.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Music Therapy
Patients in the study group were exposed to flute music therapy (Sufi musical recital - Huseyni mode) at low tempo (60-80 rhythm / min) with weak beats and calm rhythms during the UDS. This audition involves both vocal and instrumental music performed by a reed flute called 'Ney'. A competent lecturer who was specialized in music suggested all the musical compositions during the therapy

Locations

Country Name City State
Turkey Aksaray University Training and Research Hospital Aksaray

Sponsors (1)

Lead Sponsor Collaborator
Aksaray University Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Scale: VAS 10 minutes after UDS
Primary Anxiety Scale: STAI 10 minutes after UDS
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