NCT06734936

Brief Summary

Urinary catheterization is an interventional practice performed by placing a urinary catheter, which is a latex, polyurethane or silicone tube, into the bladder through the patient's urethra to evacuate the urine accumulated in the bladder for diagnosis and treatment purposes. Urinary catheterization is one of the most frequently used procedures in emergency departments. A urinary catheter is applied at least once to 5-11% of patients applying to the emergency department. Urinary catheter in emergency departments; It is applied for acute or chronic urinary retention, relief of urinary tract obstruction, determination of residual urine amount, prostate hyperplasia, drainage of hypotonic bladder, neurogenic bladder, urdodynamic examinations, contrast radiological examination, obtaining sterile urine sample and bladder irrigation in hematuria. Pain and anxiety are among the common symptoms in patients undergoing urinary catheterization. During the urinary catheterization procedure, 2% lidocaine gel is the most commonly used agent and is applied in an average amount of 6-10 ml. Since the procedure area is still sensitive despite appropriate local anesthesia, patients cannot be completely prevented from experiencing pain and anxiety . When the literature is scanned, it is reported that 75.4-95.3% of patients who underwent urinary catheterization experience pain, and that this pain is at moderate to severe levels in approximately 41.2-88.7% of the patients . Yücel found the frequency of anxiety in patients who underwent urinary catheterization to be 85%, and it was determined that 37% of this anxiety was mild, 64% was moderate, and 79% was severe . In addition to local anesthesia, parecetemol and dexketoprofen derivative painkillers can be administered orally, intramuscularly and intravenously to control pain and anxiety that may develop during and after the urinary catheterization procedure. It has been shown that these pharmacological methods used in pain and anxiety control reduce pain and anxiety in patients, but may cause some side effects such as hypotension, bradycardia, nausea and vomiting, skin rash, itching, increase the need for auxiliary personnel and equipment, and prolong the patient's hospital stay. Nurses who are with the patient for a long time have a major role in reducing pain and anxiety. In painful interventional procedures such as urinary catheterization, some non-pharmacological methods are applied by nurses to prevent pain and anxiety. In this context, practices such as music therapy and hypnosis are used . Apart from music and hypnosis, another non-pharmacological method that can be used to control pain and anxiety is Virtual Reality Glasses (VR). VR, one of the methods of diverting attention, is an advanced form of human-computer interaction that allows people to hear the sounds and stimuli accompanying the visual landscape through headphones, allowing the person to feel in another world by moving away from the hospital . Research conducted with SGG shows that virtual reality is an effective method for pain control , post-burn physiotherapy, outpatient chemotherapy treatment , port insertion, lumbar puncture, labor pain , AVF cannulation and breast biopsy , the video watched with SGG has been shown to reduce pain and anxiety. It has been shown to be effective on There is no study in the literature showing the effect of SGG use on pain and anxiety control during urinary catheter procedure. The aim of our study is to reveal the effect of virtual reality glasses on pain and anxiety in patients undergoing urinary catheter procedure. A limited amount of literature reports that virtual reality glasses are effective in controlling pain and anxiety before and during various interventional procedures. In this context, as researchers, the investigators believe that this is a study with high original value.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable pain

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2023

Completed
12 months until next milestone

First Posted

Study publicly available on registry

December 16, 2024

Completed
16 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
Last Updated

December 16, 2024

Status Verified

December 1, 2024

Enrollment Period

1 month

First QC Date

December 27, 2023

Last Update Submit

December 10, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • STATE AND TRAITING ANXIETY SCALE

    STATE AND TRAIT ANXIETY SCALE SCORING Manual Scoring: Two separate keys are prepared for each of the direct and reverse statements. Thus, the total weights of the direct statements are calculated with one key and the total weights of the reversed statements are calculated with the second key. The total weighted score for the direct statements is subtracted from the total weighted score for the reversed statements. A predetermined and unchanging value is added to this number. This constant value is 50 for the State Anxiety Scale and 35 for the Trait Anxiety Scale. The value obtained is the anxiety score of the individual.

    UP TO 8 WEEKS

Secondary Outcomes (1)

  • VISUAL ANALOGUE SCALE (VAS)

    UP TO 8 WEEKS

Study Arms (2)

experimental group

EXPERIMENTAL

SGG applied group

Other: Playing videos with sgg

control group

NO INTERVENTION

sgg unused group

Interventions

Playing videos with sgg

experimental group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Those between the ages of 18 and 65,
  • Clinically stable and easy to communicate with,
  • Able to communicate in Turkish,
  • Having no psychiatric, mental, visual or hearing problems,
  • Does not have any discomfort that would prevent him from lying in the supine position,
  • Individuals who agree to participate in the research will be included.

You may not qualify if:

  • For women who have given birth twice or more,
  • Having a history of gynecological surgery,
  • Having a history of prostate cancer,
  • Those with prostate hyperplasia
  • Having a history of urological surgery,
  • More than 2 attempts to apply a urinary catheter,
  • Those who have pain before the procedure and use any analgesic medication,
  • Using anxiolytic and/or sedative drugs,
  • Individuals who do not agree to participate in the research will not be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

selçuk öztürk, phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal İnvestigator

Study Record Dates

First Submitted

December 27, 2023

First Posted

December 16, 2024

Study Start

January 1, 2025

Primary Completion

February 1, 2025

Study Completion

April 15, 2025

Last Updated

December 16, 2024

Record last verified: 2024-12