CClinicalTrials.gg
CompletedNCT02764294Updated Mar 7, 2019

Effectiveness of the Distraction Methods During Cystoscopy

An interventional study of Music Group and Stress Ball Group in Pain, Anxiety and Satisfaction, sponsored by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi. Completed. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-07.

Sponsored by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study 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.

Read the detailed description

Cystoscopy is a reliable and effective method used commonly to investigate tumors and pathological or suspicious views related to bladder and urethra. The patients may feel pain, anxiety and dissatisfaction when cystoscope is inserted into the bladder. Thus nonpharmacological and pharmacological methods are used to decrease pain, anxiety and dissatisfaction levels of the patients during the procedure. Music is the most commonly used distraction method during cystoscopy, but there are few studies in this issue (only music) on literature. In additon, there isn't any study related to stress ball use during cystoscopy and there isn't any study which comparatives effectiveness of the multiple distraction methods to reduce pain, anxiety and dissatisfaction levels during this procedure. Therefore the investigators aimed to compare effectiveness of three different distraction methods (music, stress ball and DVD) on pain, anxiety and satisfaction of the patients during cystoscopy.

02

Conditions studied

  • Pain
  • Anxiety
  • Satisfaction

Browse trials for

Keywords

  • anxiety
  • pain
  • satisfaction
  • cystoscopy
  • music
  • video
  • stress ball
  • nursing
03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 120 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi is the lead sponsor of 65 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    Music Group

    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

  • Active comparator
    Stress Ball Group

    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

  • Active comparator
    DVD Group

    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

  • No intervention
    Control Group

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

Interventions

  • OtherMusic Group

    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.

  • OtherStress Ball Group

    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".

  • OtherDVD Group

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

06

What researchers measure

Primary outcomes

  1. Pain Measure

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

    Time frame: "5-10 minutes before", "during" and "5 minutes after" cytoscopy

Secondary outcomes

  1. Anxiety Measure

    The average score change on anxiety level as measured by STAI-State Anxiety scale.

    Time frame: "5-10 minutes before" and "5 minutes after" cytoscopy

  2. Satisfaction Measure

    The average score change on satisfaction level as measured by STAI-State Anxiety scale.

    Time frame: "5 minutes after" cytoscopy

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 19239453 ↗
  • 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. PubMed 11872022 ↗
  • 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. PubMed 26571322 ↗
  • 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. PubMed 15798411 ↗
  • 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. PubMed 12861140 ↗
  • 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. PubMed 25251958 ↗
  • 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. PubMed 18554699 ↗
  • 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. PubMed 22588748 ↗
  • 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. PubMed 25641687 ↗
  • 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. PubMed 14616460 ↗
  • 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. PubMed 25406892 ↗
  • 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. PubMed 28050795 ↗
  • 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. PubMed 27037169 ↗
  • 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. PubMed 25630866 ↗
  • 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. PubMed 20974485 ↗
  • 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. PubMed 25499026 ↗
  • 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. PubMed 16679829 ↗
  • 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. PubMed 26853024 ↗
  • 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. PubMed 24300559 ↗
  • 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. PubMed 23009573 ↗
  • 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. PubMed 24548148 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02764294
Lead sponsor
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Responsible party
Elif Gezginci (RN, PhD, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi) — Principal investigator
First posted
May 6, 2016
Start date
Mar 2016
Primary completion
Mar 2017
Completion
Mar 2017
Last update
Mar 7, 2019

Study contacts

Elif Gezginci, RN, PhD
principal investigator · University of Health Sciences, Gulhane Training and Research Hospital, Department of Urology, Ankara, Turkey

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion