Skip to main content
Clinical Trials/NCT03865459
NCT03865459
Completed
Not Applicable

The Effect of Watching Relaxing Video on Pain and Anxiety Levels of Female Patients During Cystoscopy: A Randomized Controlled Trial

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi1 site in 1 country60 target enrollmentDecember 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Enrollment
60
Locations
1
Primary Endpoint
change on pain intensity as measured by Visual Analog Scale
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The cystoscopy procedure may cause pain and anxiety in patients. Since cystoscopy causes more pain in men, studies on pain and anxiety during cystoscopy are more common in men than women. The aim of this study was to evaluate the effect of watching relaxing video during cystoscopy on the pain and anxiety levels of female patients.

Detailed Description

Cystoscopy is a safe procedure with low risk of morbidity commonly used to evaluate lower urinary tract symptoms such as hematuria, voiding disorders, irritant bladder symptoms, anatomical disorders. Patients experience pain and anxiety when cystoscope is inserted into the bladder. The various methods (drug or non-drug) are used for pain and anxiety during the cystoscopy. Although there are a lot of studies on male patients, there are limited studies evaluating pain severity in the female patients during urological procedures. In addition, there wasn't found any randomized controlled study for video use from non-drug methods to distract attention in these patients. Based on the study results in the literature, investigators aimed to evaluate the effect of watching relaxing video on the pain and anxiety levels of female patients during rigid cystoscopy.

Registry
clinicaltrials.gov
Start Date
December 1, 2017
End Date
June 1, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Responsible Party
Principal Investigator
Principal Investigator

Elif Gezginci

Principal Investigator

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Eligibility Criteria

Inclusion Criteria

  • age \> 18 years
  • female gender
  • rigid cystoscopy for the first time

Exclusion Criteria

  • presence of any contraindication for cystoscopy (such as lidocaine allergy, urinary tract infection, and urethra-related anatomical disorders)
  • any analgesic used 24 hours before cystoscopy
  • manipulations such as Double-J stent placement or removal, and/or bladder biopsy.

Outcomes

Primary Outcomes

change on pain intensity as measured by Visual Analog Scale

Time Frame: "5-10 minutes before", "during" and "5 minutes after" cytoscopy.

The average score change on pain intensity as measured by Visual Analog Scale. This scale is an unidimensional measure commonly used to measure pain intensity. The scale is a measuring tool with length of 0-10 cm (0-100 mm). High scores on the scale indicate that pain intensity is high.

Secondary Outcomes

  • score change on anxiety level as measured by State-Trait Anxiety Inventory("5-10 minutes before" and "5 minutes after" cytoscopy.)

Study Sites (1)

Loading locations...

Similar Trials