NCT03865459

Brief Summary

The cystoscopy procedure may cause pain and anxiety in patients. Since cystoscopy causes more pain in men, studies on pain and anxiety during cystoscopy are more common in men than women. The aim of this study was to evaluate the effect of watching relaxing video during cystoscopy on the pain and anxiety levels of female patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable pain

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

December 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2019

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

4 months

First QC Date

March 4, 2019

Last Update Submit

March 10, 2019

Conditions

PainAnxietyUrological NursingLower Urinary Tract Symptoms

Keywords

anxietycystoscopyfemalenursingpainvideo

Outcome Measures

Primary Outcomes (1)

  • change on pain intensity as measured by Visual Analog Scale

    The average score change on pain intensity as measured by Visual Analog Scale. This scale is an unidimensional measure commonly used to measure pain intensity. The scale is a measuring tool with length of 0-10 cm (0-100 mm). High scores on the scale indicate that pain intensity is high.

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

Secondary Outcomes (1)

  • score change on anxiety level as measured by State-Trait Anxiety Inventory

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

Study Arms (2)

Video group

EXPERIMENTAL

The video group watched relaxing video with a ceiling mounted television during the whole cystoscopy.

Other: Video group

Control group

NO INTERVENTION

The control group received the standard treatment from a surgical technician who works in the cystoscopy during the whole procedure.The control group didn't watch relaxing video during the procedure.

Interventions

Video groupOTHER

Patients in the video group started to watch the relaxing video about 5-10 minutes before cystoscopy, and continued to watch video during the whole procedure.

Video group

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 18 years
  • female gender
  • rigid cystoscopy for the first time

You may not qualify if:

  • presence of any contraindication for cystoscopy (such as lidocaine allergy, urinary tract infection, and urethra-related anatomical disorders)
  • any analgesic used 24 hours before cystoscopy
  • manipulations such as Double-J stent placement or removal, and/or bladder biopsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences

Istanbul, Turkey (Türkiye)

Location

Related Publications (10)

  • 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

  • Ellerkmann RM, McBride AW, Dunn JS, Bent AE, Blomquist JL, Kummer LG, Melick CF. A comparison of anticipatory and postprocedure pain perception in patients who undergo urodynamic procedures. Am J Obstet Gynecol. 2004 Apr;190(4):1034-8. doi: 10.1016/j.ajog.2003.11.006.

    PMID: 15118637BACKGROUND

  • Gezginci E, Iyigun E, Kibar Y, Bedir S. Three Distraction Methods for Pain Reduction During Cystoscopy: A Randomized Controlled Trial Evaluating the Effects on Pain, Anxiety, and Satisfaction. J Endourol. 2018 Nov;32(11):1078-1084. doi: 10.1089/end.2018.0491.

    PMID: 30280915BACKGROUND

  • 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

  • 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

  • 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

  • Walker MR, Kallingal GJ, Musser JE, Folen R, Stetz MC, Clark JY. Treatment efficacy of virtual reality distraction in the reduction of pain and anxiety during cystoscopy. Mil Med. 2014 Aug;179(8):891-6. doi: 10.7205/MILMED-D-13-00343.

    PMID: 25102532BACKGROUND

  • 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 DisordersLower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersUrological Manifestations

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
Principal Investigator

Study Record Dates

First Submitted

March 4, 2019

First Posted

March 6, 2019

Study Start

December 1, 2017

Primary Completion

March 22, 2018

Study Completion

June 1, 2018

Last Updated

March 12, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)