Urodynamics and Music

NCT03791177 | Completed

• 1 other identifier: AksarayUTRH2
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Incontinence, Urinary

Keywords

Music

Outcome Measures

Primary Outcomes (2)

• Pain Scale: VAS

  10 minutes after UDS

• Anxiety Scale: STAI

  10 minutes after UDS

Study Arms (2)

Study Group

EXPERIMENTAL

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

Control Group

SHAM COMPARATOR

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

Interventions

Music Therapy 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; Study Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Aksaray University Training and Research Hospital: lead

Study Sites (1)

Aksaray University Training and Research Hospital

Aksaray, 68001, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The trial was blinded for data manager ( a nurse collecting the control and study group data) and statistician.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 29, 2018
• First Posted: January 2, 2019
• Study Start: January 1, 2018
• Primary Completion: October 1, 2018
• Study Completion: December 29, 2018
• Last Updated: January 2, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)