Effectiveness of the Distraction Methods During Cystoscopy

Not Applicable

Completed

• Conditions: Pain; Anxiety; Satisfaction
• Interventions: Other: DVD Group; Other: Music Group; Other: Stress Ball Group

• Registration Number: NCT02764294
• Lead Sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-05-04
• Study First Submitted QC: 2016-05-05
• Study First Posted: 2016-05-06
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-12
• Last Update Submitted: 2019-03-05
• Last Update Posted: 2019-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DVD Group	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.
Music Group	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.
Stress Ball Group	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".

Primary Outcome Measures

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

Secondary Outcome Measures

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