Effectiveness of the Distraction Methods During Cystoscopy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Anxiety, Satisfaction

Intervention / Treatment
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* Other: Music Group
* Other: Stress Ball Group
* Other: DVD Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Music Group<br>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<br>* 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.<br>|
| Active Comparator: Stress Ball Group<br>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<br>* 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.<br>|
| Active Comparator: DVD Group<br>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<br>* DVD group was started to be watched a DVD of their choise about 10-15 minutes before cystoscopy and continued during the whole procedure.<br>|
| No Intervention: Control Group<br>Participants received usual care from health professionals. They didn't receive any intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Measure | The average score change on pain intensity as measured by VAS scale. | 5-10 minutes before, during and 5 minutes after cytoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Measure | The average score change on anxiety level as measured by STAI-State Anxiety scale. | 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. | 5 minutes after cytoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety, pain, satisfaction, cystoscopy, music, video, stress ball, nursing