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Effectiveness of the Distraction Methods During Cystoscopy

Primary Purpose

Pain, Anxiety, Satisfaction

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Music Group
Stress Ball Group
DVD Group
Sponsored by
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pain focused on measuring anxiety, pain, satisfaction, cystoscopy, music, video, stress ball, nursing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    No Intervention

    Arm Label

    Music Group

    Stress Ball Group

    DVD Group

    Control Group

    Arm Description

    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 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 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.

    Participants received usual care from health professionals. They didn't receive any intervention.

    Outcomes

    Primary Outcome Measures

    Pain Measure
    The average score change on pain intensity as measured by VAS scale.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    May 4, 2016
    Last Updated
    March 5, 2019
    Sponsor
    Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02764294
    Brief Title
    Effectiveness of the Distraction Methods During Cystoscopy
    Official Title
    Effectiveness of the Distraction Methods on Pain, Anxiety and Satisfaction During Cystoscopy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2016 (Actual)
    Primary Completion Date
    March 2017 (Actual)
    Study Completion Date
    March 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Anxiety, Satisfaction
    Keywords
    anxiety, pain, satisfaction, cystoscopy, music, video, stress ball, nursing

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Music Group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Stress Ball Group
    Arm Type
    Active Comparator
    Arm Description
    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".
    Arm Title
    DVD Group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    Participants received usual care from health professionals. They didn't receive any intervention.
    Intervention Type
    Other
    Intervention Name(s)
    Music Group
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Stress Ball Group
    Intervention Description
    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".
    Intervention Type
    Other
    Intervention Name(s)
    DVD Group
    Intervention Description
    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 Outcome Measure Information:
    Title
    Pain Measure
    Description
    The average score change on pain intensity as measured by VAS scale.
    Time Frame
    "5-10 minutes before", "during" and "5 minutes after" cytoscopy
    Secondary Outcome Measure Information:
    Title
    Anxiety Measure
    Description
    The average score change on anxiety level as measured by STAI-State Anxiety scale.
    Time Frame
    "5-10 minutes before" and "5 minutes after" cytoscopy
    Title
    Satisfaction Measure
    Description
    The average score change on satisfaction level as measured by STAI-State Anxiety scale.
    Time Frame
    "5 minutes after" cytoscopy

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elif Gezginci, RN, PhD
    Organizational Affiliation
    University of Health Sciences, Gulhane Training and Research Hospital, Department of Urology, Ankara, Turkey
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Citation
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