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Urodynamics and Music

Primary Purpose

Incontinence, Urinary

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Music Therapy
Sponsored by
Aksaray University Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Incontinence, Urinary focused on measuring Music

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Aksaray University Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Study Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain Scale: VAS
Anxiety Scale: STAI

Secondary Outcome Measures

Full Information

First Posted
December 29, 2018
Last Updated
December 31, 2018
Sponsor
Aksaray University Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03791177
Brief Title
Urodynamics and Music
Official Title
The Effects of Listening to Music on Anxiety, Pain and Satisfaction During Urodynamic Study : A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
December 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aksaray University Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incontinence, Urinary
Keywords
Music

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Masking Description
The trial was blinded for data manager ( a nurse collecting the control and study group data) and statistician.
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Music Therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain Scale: VAS
Time Frame
10 minutes after UDS
Title
Anxiety Scale: STAI
Time Frame
10 minutes after UDS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Aksaray University Training and Research Hospital
City
Aksaray
ZIP/Postal Code
68001
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Urodynamics and Music

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