NCT07327671

Brief Summary

In female patients, the dorsal recumbent position is required to visualize the urethral meatus. In female patients, direct visualization of the urethral meatus after providing a suitable position is very important for successful catheter advancement while maintaining sterile conditions. Especially in unconscious or uncooperative female patients, it is much more difficult to maintain and maintain an appropriate position, and more than one staff may be needed for this. Although it is clear that it is important and difficult to position female patients during catheterization and maintain it throughout the procedure, no device used to assist positioning has been encountered. Therefore, in this project; The aim of this study is to provide a comfortable and safe position for the patient in urinary catheterization in female patients, to develop an auxiliary device to maintain this position throughout the procedure, and to evaluate the effectiveness of this device.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 27, 2023

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2024

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
Last Updated

January 8, 2026

Status Verified

February 1, 2024

Enrollment Period

7 months

First QC Date

March 17, 2023

Last Update Submit

December 25, 2025

Conditions

Randomised Controlled TrialUrinary CatheterizationDeviceNursingPositioning (Prone, Right Lateral and Semi-Elevated Supine Position)

Keywords

urinary catheterizationassistive devicenursingusebility testingrandomized cross-over trialpositioning device

Outcome Measures

Primary Outcomes (4)

  • Urinary Catheterization Procedure Time (minutes)

    Total time required to complete the urinary catheterization procedure, measured in minutes from video recordings, including preparation time, catheter insertion time, and total procedure duration.

    From the start to the end of the catheterisation procedure, a maximum of 10 minutes

  • Nurses' Lumbar Fatigue (Visual Analog Scale, VAS 0-100)

    Lower back fatigue experienced by nurses during the procedure, assessed using a Visual Analogue Scale (VAS) from 0 to 100, where higher scores indicate greater fatigue.

    Day 1

  • Need for Support Personnel

    Requirement for additional support staff during the procedure, recorded as yes/no based on video analysis.

    Day 1

  • Nurses' Physical Effort (Visual Analog Scale, VAS 0-100)

    Physical effort perceived by nurses during the catheterization procedure, measured using a Visual Analogue Scale (VAS) from 0 to 100, where higher scores indicate greater physical effort.

    Day 1

Secondary Outcomes (1)

  • User Satisfaction (QUEST 2.0)

    Day 1

Study Arms (2)

dorsal recumbent positioning device

EXPERIMENTAL

procedure performed with dorsal recumbent positioning device

Device: dorsal recumbent positioning device

Control group

NO INTERVENTION

Interventions

dorsal recumbent positioning deviceDEVICE

Participants in the supine positioning device group use this device prior to the procedure to ensure the supine position during urinary catheterisation in female patients. Once this device has safely secured the position, the steps for urinary catheterisation are carried out.

dorsal recumbent positioning device

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Being a nurse with at least a bachelor's degree
  • Previous experience of urinary catheterization
  • Having worked or working in intensive care
  • Having voluntarily agreed to participate in the research

You may not qualify if:

  • Leaving work voluntarily

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences Turkey, Gulhane Faculty of Nursing, Ankara, Turkey

Ankara, Turkey (Türkiye)

Location

Related Publications (2)

  • Fletcher-Gutowski S, Cecil J. Is 2-person urinary catheter insertion effective in reducing CAUTI? Am J Infect Control. 2019 Dec;47(12):1508-1509. doi: 10.1016/j.ajic.2019.05.014. Epub 2019 Jul 16.

    PMID: 31324489BACKGROUND

  • Santos-Costa P, Alves M, Sousa C, Sousa LB, Paiva-Santos F, Bernardes RA, Ventura F, Salgueiro-Oliveira A, Parreira P, Vieira M, Graveto J. Nurses' Involvement in the Development and Usability Assessment of an Innovative Peripheral Intravenous Catheterisation Pack: A Mix-Method Study. Int J Environ Res Public Health. 2022 Sep 5;19(17):11130. doi: 10.3390/ijerph191711130.

    PMID: 36078842BACKGROUND

Related Links

Study Design

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

Study Record Dates

First Submitted

March 17, 2023

First Posted

January 8, 2026

Study Start

February 27, 2023

Primary Completion

September 29, 2023

Study Completion

February 21, 2024

Last Updated

January 8, 2026

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)