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OpenTrials
Completed

NCT Number: NCT02764294

Effectiveness of the Distraction Methods 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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music group

Other

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

Other

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 Group

Other

DVD group was started to be watched a DVD of their choise about 10-15 minutes before cystoscopy and continued during the whole procedure.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Anxiety Measure

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

    The average score change on anxiety level as measured by STAI-State Anxiety scale.

  2. Satisfaction Measure

    Time frame: "5 minutes after" cytoscopy

    The average score change on satisfaction level as measured by STAI-State Anxiety scale.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 6, 2016
Registry last updated
Mar 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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