The Effect of Watching Relaxing Video During Cystoscopy

Not Applicable

Completed

• Conditions: Lower Urinary Tract Symptoms; Anxiety; Pain; Urological Nursing
• Interventions: Other: Video group

• Registration Number: NCT03865459
• Lead Sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

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.

Study Timeline

• Study Start: 2017-12-01
• Primary Completion: 2018-03-22
• Study Completion: 2018-06-01
• Status Verified: 2019-03
• Study First Submitted: 2019-03-04
• Study First Submitted QC: 2019-03-05
• Study First Posted: 2019-03-06
• Last Update Submitted: 2019-03-10
• Last Update Posted: 2019-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Video group	Video group	The video group watched relaxing video with a ceiling mounted television during the whole cystoscopy.

Primary Outcome Measures

Name	Time	Method
change on pain intensity as measured by Visual Analog Scale	"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 Outcome Measures

Name	Time	Method
score change on anxiety level as measured by State-Trait Anxiety Inventory	"5-10 minutes before" and "5 minutes after" cytoscopy.	The average score change on anxiety level as measured by State-Trait Anxiety Inventory. This scale is used to measure anxiety. The scores on the scale ranges from 20 to 80. The high scores on the scale indicate that anxiety is high.

Trial Locations

Locations (1)

University of Health Sciences; 🇹🇷 Istanbul, Turkey