NCT02764294

Brief Summary

Cystoscopy is a pain procedure and patients may experience anxiety and dissatisfaction before and during the procedure. Especially male patients feel more pain than females during cystoscopy. The aim of this study is to compare effectiveness of three different distraction methods on pain, anxiety and satisfaction of the male patients during cystoscopy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Mar 2016

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

March 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 7, 2019

Status Verified

December 1, 2017

Enrollment Period

1 year

First QC Date

May 4, 2016

Last Update Submit

March 5, 2019

Conditions

PainAnxietySatisfaction

Keywords

anxietypainsatisfactioncystoscopymusicvideostress ballnursing

Outcome Measures

Primary Outcomes (1)

  • Pain Measure

    The average score change on pain intensity as measured by VAS scale.

    "5-10 minutes before", "during" and "5 minutes after" cytoscopy

Secondary Outcomes (2)

  • Anxiety Measure

    "5-10 minutes before" and "5 minutes after" cytoscopy

  • Satisfaction Measure

    "5 minutes after" cytoscopy

Study Arms (4)

Music Group

ACTIVE COMPARATOR

Music group was listened to a music of their choise with a headset. The music intervention was started about 10-15 minutes before cystoscopy and continued during the whole procedure. Types of music were Turkish folk music, Turkish art music, Turkish arabesque music, Turkish pop music, foreign pop music, rock music, and classical music.

Other: Music Group

Stress Ball Group

ACTIVE COMPARATOR

Stress ball group was given stress ball into both their palms about 10-15 minutes before cystoscopy. Participants were instructed to "squeeze the balls twice after counting up to five" and "repeat it until the end of the procedure".

Other: Stress Ball Group

DVD Group

ACTIVE COMPARATOR

DVD group was watched a DVD of their choice (documentaries, interesting and amazing videos, comedies) on a ceiling-mounted monitor positioned at a comfortable distance to the participant.

Other: DVD Group

Control Group

NO INTERVENTION

Participants received usual care from health professionals. They didn't receive any intervention.

Interventions

Music GroupOTHER

Music group was listened to a music of their choise with a headset. The music intervention was started about 10-15 minutes before cystoscopy and continued during the whole procedure. Types of music were Turkish folk music, Turkish art music, Turkish arabesque music, Turkish pop music, foreign pop music, rock music, and classical music.

Music Group
Stress Ball GroupOTHER

Music group was given stress ball into both their palms about 10-15 minutes before cystoscopy. Participants were instructed to "squeeze the balls twice after counting up to five" and "repeat it until the end of the procedure".

Stress Ball Group
DVD GroupOTHER

DVD group was started to be watched a DVD of their choise about 10-15 minutes before cystoscopy and continued during the whole procedure.

DVD Group

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to be male and over 18 years old
  • to be first csytoscopy
  • to be rigid csytoscopy

You may not qualify if:

  • to have a contradiction for csystoscopy (lidocaine allergies, urinary tract infection, no anatomical problems with the urethra etc.)
  • to be used any analgesic drug at least 24 hours prior to cystoscopy
  • to be made manipulations such as double j stent placement or removal, and bladder biopsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (21)

  • Aaronson DS, Walsh TJ, Smith JF, Davies BJ, Hsieh MH, Konety BR. Meta-analysis: does lidocaine gel before flexible cystoscopy provide pain relief? BJU Int. 2009 Aug;104(4):506-9; discussion 509-10. doi: 10.1111/j.1464-410X.2009.08417.x. Epub 2009 Feb 23.

    PMID: 19239453BACKGROUND

  • Burke DM, Shackley DC, O'Reilly PH. The community-based morbidity of flexible cystoscopy. BJU Int. 2002 Mar;89(4):347-9. doi: 10.1046/j.1464-4096.2001.01899.x.

    PMID: 11872022BACKGROUND

  • Cano-Garcia Mdel C, Casares-Perez R, Arrabal-Martin M, Merino-Salas S, Arrabal-Polo MA. Use of Lidocaine 2% Gel Does Not Reduce Pain during Flexible Cystoscopy and Is Not Cost-Effective. Urol J. 2015 Nov 14;12(5):2362-5.

    PMID: 26571322BACKGROUND

  • Chen YT, Hsiao PJ, Wong WY, Wang CC, Yang SS, Hsieh CH. Randomized double-blind comparison of lidocaine gel and plain lubricating gel in relieving pain during flexible cystoscopy. J Endourol. 2005 Mar;19(2):163-6. doi: 10.1089/end.2005.19.163.

    PMID: 15798411BACKGROUND

  • Ellerkmann RM, Dunn JS, McBride AW, Kummer LG, Melick CF, Bent AE, Blomquist JL. A comparison of anticipated pain before and pain rating after the procedure in patients who undergo cystourethroscopy. Am J Obstet Gynecol. 2003 Jul;189(1):66-9. doi: 10.1067/mob.2003.377.

    PMID: 12861140BACKGROUND

  • Greenstein A, Greenstein I, Senderovich S, Mabjeesh NJ. Is diagnostic cystoscopy painful? Analysis of 1,320 consecutive procedures. Int Braz J Urol. 2014 Jul-Aug;40(4):533-8. doi: 10.1590/S1677-5538.IBJU.2014.04.13.

    PMID: 25251958BACKGROUND

  • Gunendran T, Briggs RH, Wemyss-Holden GD, Neilson D. Does increasing hydrostatic pressure ("bag squeeze") during flexible cystoscopy improve patient comfort: a randomized, controlled study. Urology. 2008 Aug;72(2):255-8; discussion 258-9. doi: 10.1016/j.urology.2008.02.072. Epub 2008 Jun 12.

    PMID: 18554699BACKGROUND

  • Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.

    PMID: 22588748BACKGROUND

  • Hudson BF, Ogden J, Whiteley MS. Randomized controlled trial to compare the effect of simple distraction interventions on pain and anxiety experienced during conscious surgery. Eur J Pain. 2015 Nov;19(10):1447-55. doi: 10.1002/ejp.675. Epub 2015 Jan 30.

    PMID: 25641687BACKGROUND

  • Kesari D, Kovisman V, Cytron S, Benjamin J. Effects on pain and anxiety of patients viewing their cystoscopy in addition to a detailed explanation: a controlled study. BJU Int. 2003 Nov;92(7):751-2. doi: 10.1046/j.1464-410x.2003.04477.x.

    PMID: 14616460BACKGROUND

  • Kim JH, Park SY, Kim MG, Choi H, Song D, Cho SW, Song YS. Pain and satisfaction during rigid cystoscopic ureteral stent removal: a preliminary study. BMC Urol. 2014 Nov 18;14:90. doi: 10.1186/1471-2490-14-90.

    PMID: 25406892BACKGROUND

  • Krajewski W, Koscielska-Kasprzak K, Rymaszewska J, Zdrojowy R. How different cystoscopy methods influence patient sexual satisfaction, anxiety, and depression levels: a randomized prospective trial. Qual Life Res. 2017 Mar;26(3):625-634. doi: 10.1007/s11136-016-1493-1. Epub 2017 Jan 3.

    PMID: 28050795BACKGROUND

  • Li H, Cheng Y, Li J, Chen Y, Yuan J, Yang S, Shi H, Li W, Yang S, Wang W, Xu G, Zhao S. NaHCO3-Buffered Lidocaine Gel for Outpatient Rigid Cystoscopy in Men. J Perianesth Nurs. 2016 Apr;31(2):154-7. doi: 10.1016/j.jopan.2014.05.014. Epub 2016 Jan 8.

    PMID: 27037169BACKGROUND

  • Raheem OA, Mirheydar HS, Lee HJ, Patel ND, Godebu E, Sakamoto K. Does Listening to Music During Office-Based Flexible Cystoscopy Decrease Anxiety in Patients: A Prospective Randomized Trial. J Endourol. 2015 Jul;29(7):791-6. doi: 10.1089/end.2015.0029. Epub 2015 Apr 13.

    PMID: 25630866BACKGROUND

  • Soomro KQ, Nasir AR, Ather MH. Impact of patient's self-viewing of flexible cystoscopy on pain using a visual analog scale in a randomized controlled trial. Urology. 2011 Jan;77(1):21-3. doi: 10.1016/j.urology.2010.08.012. Epub 2010 Oct 25.

    PMID: 20974485BACKGROUND

  • Stewart M, Cox-Davenport RA. Comparative Analysis of Registered Nurses' and Nursing Students' Attitudes and Use of Nonpharmacologic Methods of Pain Management. Pain Manag Nurs. 2015 Aug;16(4):499-502. doi: 10.1016/j.pmn.2014.09.010. Epub 2014 Dec 12.

    PMID: 25499026BACKGROUND

  • Taghizadeh AK, El Madani A, Gard PR, Li CY, Thomas PJ, Denyer SP. When does it hurt? Pain during flexible cystoscopy in men. Urol Int. 2006;76(4):301-3. doi: 10.1159/000092051.

    PMID: 16679829BACKGROUND

  • Wang DS. Re: Does Listening to Music during Office-Based Flexible Cystoscopy Decrease Anxiety in Patients: A Prospective Randomized Trial. J Urol. 2016 Feb;195(2):448-9. doi: 10.1016/j.juro.2015.10.153. Epub 2015 Nov 2. No abstract available.

    PMID: 26853024BACKGROUND

  • Yerlikaya G, Laml T, Elenskaia K, Hanzal E, Kolbl H, Umek W. Pain perception during outpatient cystoscopy: a prospective controlled study. Eur J Obstet Gynecol Reprod Biol. 2014 Feb;173:101-5. doi: 10.1016/j.ejogrb.2013.11.007. Epub 2013 Nov 14.

    PMID: 24300559BACKGROUND

  • Yeo JK, Cho DY, Oh MM, Park SS, Park MG. Listening to music during cystoscopy decreases anxiety, pain, and dissatisfaction in patients: a pilot randomized controlled trial. J Endourol. 2013 Apr;27(4):459-62. doi: 10.1089/end.2012.0222. Epub 2012 Dec 5.

    PMID: 23009573BACKGROUND

  • Zhang ZS, Wang XL, Xu CL, Zhang C, Cao Z, Xu WD, Wei RC, Sun YH. Music reduces panic: an initial study of listening to preferred music improves male patient discomfort and anxiety during flexible cystoscopy. J Endourol. 2014 Jun;28(6):739-44. doi: 10.1089/end.2013.0705. Epub 2014 Mar 31.

    PMID: 24548148BACKGROUND

MeSH Terms

Conditions

PainAnxiety DisordersPersonal Satisfaction

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehavior

Study Officials

  • Elif Gezginci, RN, PhD

    University of Health Sciences, Gulhane Training and Research Hospital, Department of Urology, Ankara, Turkey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, PhD

Study Record Dates

First Submitted

May 4, 2016

First Posted

May 6, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

March 7, 2019

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share