Clinical trial NCT02764294: Effectiveness of the Distraction Methods During Cystoscopy
Official title: Effectiveness of the Distraction Methods on Pain, Anxiety and Satisfaction During Cystoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Satisfaction
Keywords: anxiety
pain
satisfaction
cystoscopy
music
video
stress ball
nursing
Lead sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Sponsor class: OTHER
First posted: 2016-05-06
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: Inclusion Criteria:

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

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

Primary outcomes:
measure: Pain Measure
timeFrame: "5-10 minutes before", "during" and "5 minutes after" cytoscopy
Secondary outcomes:
measure: Anxiety Measure
timeFrame: "5-10 minutes before" and "5 minutes after" cytoscopy
measure: Satisfaction Measure
timeFrame: "5 minutes after" cytoscopy
Other outcomes:
Locations:
Study officials:
affiliation: University of Health Sciences, Gulhane Training and Research Hospital, Department of Urology, Ankara, Turkey
name: Elif Gezginci, RN, PhD
role: PRINCIPAL_INVESTIGATOR
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