PainNCT02764294

Effectiveness of the Distraction Methods During Cystoscopy

A study testing Music Group, Stress Ball Group and DVD Group in people with Pain and Anxiety, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: Pain, Anxiety, Satisfaction
What is being tested?: Music Group, Stress Ball Group and DVD Group
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: No sites listed yet
Study dates: Mar 2016to Mar 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: Effectiveness of the Distraction Methods on Pain, Anxiety and Satisfaction During Cystoscopy

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.

Conditions: Pain, Anxiety, Satisfaction
Being tested: Music Group, Stress Ball Group, DVD Group
Keywords: anxiety, pain, satisfaction, cystoscopy, music, video, stress ball, nursing
Medical subject headings: Pain, Anxiety Disorders, Personal Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.
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".
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.

Study groups in NCT02764294
Study group	Role	What they receive
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. Receives: 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". Receives: 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. Receives: Other: DVD Group
Control Group	No intervention	Participants received usual care from health professionals. They didn't receive any intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain Measure
The average score change on pain intensity as measured by VAS scale.
Measured: "5-10 minutes before", "during" and "5 minutes after" cytoscopy

Secondary outcomes (2)

Anxiety Measure
The average score change on anxiety level as measured by STAI-State Anxiety scale.
Measured: "5-10 minutes before" and "5 minutes after" cytoscopy
Satisfaction Measure
The average score change on satisfaction level as measured by STAI-State Anxiety scale.
Measured: "5 minutes after" cytoscopy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2016Mar 2017

First posted6 May 2016 (estimated)
Study startMar 2016
Primary completionMar 2017
Study completionMar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02764294
Sponsor's protocol ID: 50687469-1491-263-16/1648-736
Status last verified: Dec 2017
First submitted: 4 May 2016
Last updated: 7 Mar 2019
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of the Distraction Methods on Pain, Anxiety and Satisfaction During Cystoscopy
ClinicalTrials.gov ID: NCT02764294
Acronym / sponsor ID: 50687469-1491-263-16/1648-736
Conditions: Pain, Anxiety, Satisfaction
Keywords: anxiety, pain, satisfaction, cystoscopy, music, video, stress ball, nursing
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
Study start: Mar 2016 (actual)
Primary completion: Mar 2017 (actual)
Study completion: Mar 2017 (actual)
First posted: 6 May 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Music Group	Active comparator	Other: Music GroupMusic 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.
Stress Ball Group	Active comparator	Other: Stress Ball GroupStress 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".
DVD Group	Active comparator	Other: DVD GroupDVD 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.
Control Group	No intervention	–Participants received usual care from health professionals. They didn't receive any intervention.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Music GroupMusic 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 GroupMusic 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 GroupDVD group was started to be watched a DVD of their choise about 10-15 minutes before cystoscopy and continued during the whole procedure.	Other	DVD Group

Primary outcome

Pain Measure
Time frame: "5-10 minutes before", "during" and "5 minutes after" cytoscopy
The average score change on pain intensity as measured by VAS scale.

2 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
Background: PubMed 19239453Aaronson 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.
Background: PubMed 11872022Burke 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.
Background: PubMed 26571322Cano-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.
Background: PubMed 15798411Chen 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.
Background: PubMed 12861140Ellerkmann 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.
Background: PubMed 25251958Greenstein 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.
Background: PubMed 18554699Gunendran 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.
Background: PubMed 22588748Hawker 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.
Background: PubMed 25641687Hudson 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.
Background: PubMed 14616460Kesari 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.
Background: PubMed 25406892Kim 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.
Background: PubMed 28050795Krajewski 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elif Gezginci, RN, PhD principal investigator

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

Questions about this trial

What is this clinical trial studying?

A study testing Music Group, Stress Ball Group and DVD Group in people with Pain and Anxiety, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Measure (time frame: "5-10 minutes before", "during" and "5 minutes after" cytoscopy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02764294, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2019.