Urodynamics and Music

NCT ID: NCT03791177

Last Updated: 2019-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2018-12-29

Brief 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

Detailed 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.

Conditions

Incontinence, Urinary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Study Group

A total of 70 patients were included in the study. Using simple randomization method, the patients were acknowledged about the aim of the study and the cards with letters C (control) and S (study) were placed in closed envelopes and the patients were asked to draw a random envelope. After the draw, two groups were formed according to the letter as group I consisted of patients with C letter and group II consisted of patients with S letter.

Group Type: EXPERIMENTAL

Music Therapy

Intervention Type: OTHER

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

Control Group

A total of 70 patients were included in the study. Using simple randomization method, the patients were acknowledged about the aim of the study and the cards with letters C (control) and S (study) were placed in closed envelopes and the patients were asked to draw a random envelope. After the draw, two groups were formed according to the letter as group I consisted of patients with C letter and group II consisted of patients with S letter.

Group Type: SHAM_COMPARATOR

Music Therapy

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aksaray University Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Murat Gül

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aksaray University Training and Research Hospital

Aksaray, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AksarayUTRH2

Identifier Type: -

Identifier Source: org_study_id