Effectiveness of the Distraction Methods During Cystoscopy

March 5, 2019 updated by: Elif Gezginci, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Effectiveness of the Distraction Methods on Pain, Anxiety and Satisfaction 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
"5-10 minutes before", "during" and "5 minutes after" cytoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
"5-10 minutes before" and "5 minutes after" cytoscopy
Satisfaction Measure
Time Frame: "5 minutes after" cytoscopy
The average score change on satisfaction level as measured by STAI-State Anxiety scale.
"5 minutes after" cytoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Investigators

  • Principal Investigator: Elif Gezginci, RN, PhD, University of Health Sciences, Gulhane Training and Research Hospital, Department of Urology, Ankara, Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

May 4, 2016

First Submitted That Met QC Criteria

May 5, 2016

First Posted (Estimate)

May 6, 2016

Study Record Updates

Last Update Posted (Actual)

March 7, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 50687469-1491-263-16/1648-736

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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