The Effect of Watching Relaxing Video During Cystoscopy

Sponsor
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi (Other)
Overall Status
Completed
CT.gov ID
NCT03865459
Collaborator
(none)
60
1
2
6
10

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Video group
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
The Effect of Watching Relaxing Video on Pain and Anxiety Levels of Female Patients During Cystoscopy: A Randomized Controlled Trial
Actual Study Start Date :
Dec 1, 2017
Actual Primary Completion Date :
Mar 22, 2018
Actual Study Completion Date :
Jun 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Video group

The video group watched relaxing video with a ceiling mounted television during the whole cystoscopy.

Other: Video group
Patients in the video group started to watch the relaxing video about 5-10 minutes before cystoscopy, and continued to watch video during the whole procedure.

No Intervention: Control group

The control group received the standard treatment from a surgical technician who works in the cystoscopy during the whole procedure.The control group didn't watch relaxing video during the procedure.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Health Sciences Istanbul Turkey

Sponsors and Collaborators

  • Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Elif Gezginci, Principal Investigator, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
ClinicalTrials.gov Identifier:
NCT03865459
Other Study ID Numbers:
  • 46418926
First Posted:
Mar 6, 2019
Last Update Posted:
Mar 12, 2019
Last Verified:
Mar 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Elif Gezginci, Principal Investigator, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 12, 2019