Overview

This trial is active, not recruiting.

Conditions pain, anxiety, satisfaction
Treatments music group, stress ball group, dvd group
Sponsor Gulhane Military Medical Academy
Start date March 2016
End date May 2017
Trial size 112 participants
Trial identifier NCT02764294, 50687469-1491-263-16/1648-736

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Active Comparator)
Music group was listened to a music of their choise with a headset. The music intervention was started 5 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.
music group
Music group was listened to a music of their choise with a headset. The music intervention was started 5 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.
(Active Comparator)
Stress ball group was given stress ball into both their palms 5 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".
stress ball group
Music group was given stress ball into both their palms 5 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".
(Active Comparator)
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.
dvd group
DVD group was started to be watched a DVD of their choise 5 minutes before cystoscopy and continued during the whole procedure.
(No Intervention)
Participants received usual care from health professionals. They didn't receive any intervention.

Primary Outcomes

Measure
Pain
time frame: "5 minutes before", "during" and "5 minutes after" cytoscopy

Secondary Outcomes

Measure
Anxiety
time frame: "5 minutes before" and "5 minutes after" cytoscopy
Satisfaction
time frame: "during" and "5 minutes after" cytoscopy

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title Effectiveness of the Distraction Methods on Pain, Anxiety and Satisfaction During Cystoscopy
Principal investigator Elif Gezginci, RN,Msc,PhDs
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Gulhane Military Medical Academy.