Urodynamics and Music

Sponsor

Aksaray University Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03791177

Collaborator

(none)

Enrollment

Location

Arms

11.9

Actual Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Incontinence, Urinary	Other: Music Therapy	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Masking Description:

The trial was blinded for data manager ( a nurse collecting the control and study group data) and statistician.

Primary Purpose:

Treatment

Official Title:

The Effects of Listening to Music on Anxiety, Pain and Satisfaction During Urodynamic Study : A Randomized Controlled Trial

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Oct 1, 2018

Actual Study Completion Date :

Dec 29, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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
Sham Comparator: 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.	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

Arm

Intervention/Treatment

Experimental: 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.

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

Sham Comparator: Control Group

Other: Music Therapy

Outcome Measures

Primary Outcome Measures

Pain Scale: VAS [10 minutes after UDS]
Anxiety Scale: STAI [10 minutes after UDS]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aksaray University Training and Research Hospital	Aksaray		Turkey	68001

Sponsors and Collaborators

Aksaray University Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Murat Gül, Assistant Professor, Aksaray University Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT03791177

Other Study ID Numbers:

AksarayUTRH2

First Posted:

Jan 2, 2019

Last Update Posted:

Jan 2, 2019

Last Verified:

Dec 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Murat Gül, Assistant Professor, Aksaray University Training and Research Hospital

Music

Additional relevant MeSH terms:

Urinary Incontinence

Enuresis

Study Results

No Results Posted as of Jan 2, 2019