NCT04595344

Brief Summary

This study aimed to investigate the effects of pure binaural beats on anxiety levels and pain scores using the State-Trait Anxiety Inventory (STAI) questionnaire and Visual Analog Scale (VAS) in male patients undergoing DC and USR procedures under local anesthesia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
352

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 8, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

9 months

First QC Date

October 14, 2020

Last Update Submit

July 21, 2021

Conditions

AnxietyCystoscopyPain

Keywords

AnxietyBinaural beatsCystoscopyPainUreteral Stent Removal

Outcome Measures

Primary Outcomes (2)

  • Binaural beats and anxiety levels

    Effects of listening to binaural beats on axiety levels before diagnostic cystoscopy and ureteral stent removal procedures. STAI was used to assess the anxiety levels of the patients. STAI scores range from 20 to 80. Higher STAI scores indicate increased anxiety levels

    10 minutes

  • Binaural beats and pain scores

    Effects of listening to binaural beats on pain scores during diagnostic cystoscopy and ureteral stent removal procedures. VAS vas used to assess the pain scores of patients. The VAS is a common tool in which patients score their pain level on a scale between 0 (no pain) and 10 ( worst pain possible).

    8 minute

Secondary Outcomes (2)

  • Classical Music and anxiety levels.

    10 minutes

  • Classical music and pain scores

    8 minutes

Study Arms (6)

Diagnostic cystoscopy , Binaural beat group

ACTIVE COMPARATOR

patients listened to binaural beats

Other: Listening to Pure Binaural Beats

Diagnostic cystoscopy, Classical music group

ACTIVE COMPARATOR

patients listened to classical music

Other: Listening to classical music

Diagnostic cystoscopy , Placebo group

PLACEBO COMPARATOR

patients no audio only headphones

Other: No audio only headphone

Ureteral stent removal, Binaural beat group

ACTIVE COMPARATOR

patients listened to binaural beats

Other: Listening to Pure Binaural Beats

Ureteral stent removal ,Classical music group

ACTIVE COMPARATOR

patients listened to classical music

Other: Listening to classical music

Ureteral stent removal, Placebo group

PLACEBO COMPARATOR

patients no audio only headphones

Other: No audio only headphone

Interventions

Listening to Pure Binaural BeatsOTHER

The patients in DCG ((binaural beat group) ) and USRG (binaural beat group) listened to binaural beats.The binaural beats were produced using a software program (Audacity®, version win. 2.3.2, 2019 Audacity Team) at frequency of 10 Hz (a tone of 200 Hz in the right ear and a tone of 210 Hz in the left ear). The binaural beats that the patients in DCG-1 and USRG-1 listened to were "pure" frequencies, with no background music or waves.

Diagnostic cystoscopy , Binaural beat groupUreteral stent removal, Binaural beat group
Listening to classical musicOTHER

The patients in DCG (classical music group) and USRG (classical music group) listened to classical music.The classical music that those in DCG-2 and USRG-2 listened to was Mozart's 40th Symphony.

Diagnostic cystoscopy, Classical music groupUreteral stent removal ,Classical music group
No audio only headphoneOTHER

The patients in DCG (placebo group) and USRG (placebo group) sat in a quiet room with headphones on but no audio playing

Diagnostic cystoscopy , Placebo groupUreteral stent removal, Placebo group

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male patient
  • negative urine culture
  • at least formal schooling (1-8 y of education)

You may not qualify if:

  • hearing or vision problems
  • neurological deficits
  • mental retardation
  • history of chronic pelvic pain syndrome
  • history of previous DC or USR procedures
  • antidepressant use or analgesia use 24 h before the procedure
  • decline to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya Training and Research Hospital

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersPain

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mahmut Taha MO Ölçücü

    Antalya Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

October 14, 2020

First Posted

October 20, 2020

Study Start

July 8, 2019

Primary Completion

March 26, 2020

Study Completion

April 10, 2020

Last Updated

July 28, 2021

Record last verified: 2021-07

Locations

TU(1)