Effect of a Urinary Catheter Carrying Bag on Satisfaction, Body Image, Self-Esteem, and Shame

NCT ID: NCT07053501

Last Updated: 2025-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aimed to evaluate the impact of using an innovative urinary catheter carrying bag on the psychosocial well-being of patients who require long-term catheterization. The bag was designed to increase comfort, hygiene, and privacy by concealing the urine bag and minimizing potential embarrassment during daily activities.

A total of 70 patients who had been using an indwelling urinary catheter for at least three weeks were randomly assigned to either an intervention or a control group. The intervention group received a specially designed catheter carrying bag along with training on how to use it, while the control group received standard care without the carrying bag. All participants were monitored over a 21-day period.

Validated assessment tools were used to measure patient satisfaction, body image, self-esteem, and feelings of external shame at baseline and after the intervention period. The study was designed to explore whether the use of the catheter carrying bag could influence these psychosocial outcomes in individuals undergoing long-term catheterization.

This randomized controlled trial was conducted to inform future supportive care practices and explore non-pharmacological interventions that address both the physical and psychosocial needs of patients with indwelling urinary catheters.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This randomized controlled trial was conducted between July and December 2023 in the Emergency and Urology departments of X State Hospital. The aim was to investigate the effects of an innovative urinary catheter carrying bag (UCCB) on patients' psychosocial outcomes, including satisfaction, body image, self-esteem, and feelings of shame.

Participants (n=70) were adults aged 18 and older who had been using an indwelling urinary catheter for at least three weeks. Following ethical approval and informed consent, they were randomly assigned to intervention or control groups. The intervention group received a urinary catheter carrying bag along with detailed training, while the control group continued with standard care.

Data collection tools included the Patient Satisfaction-VAS, Body Image Scale, Rosenberg Self-Esteem Scale, and The Other as Shamer Scale. Assessments were conducted before the intervention and after the 21-day follow-up period.

Statistical analyses revealed that patients using the UCCB showed significantly greater improvements in all primary outcomes compared to the control group. Regression models confirmed that the carrying bag had a significant positive effect on patient satisfaction and self-esteem, and a significant negative effect on body image disturbance and shame.

This study provides empirical evidence that a simple, low-cost supportive device can positively influence the psychological well-being of catheter users. The findings suggest that integrating such tools into standard nursing protocols may improve holistic patient care.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Long-Term Urinary Catheterization Patient Satisfaction Psychosocial Impact of Catheter Use Low Self-Esteem Body Image Disturbance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

Patients used a specially designed urinary catheter carrying bag for 21 days along with training.

Group Type EXPERIMENTAL

Urinary Catheter Carrying Bag Use

Intervention Type DEVICE

A wearable catheter carrying bag was provided to participants. It was designed to conceal the urine bag and increase comfort, privacy, and psychosocial well-being. Participants received training on its use and wore it during all daily activities for 21 days.

Control

Patients received routine catheter care without any intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Urinary Catheter Carrying Bag Use

A wearable catheter carrying bag was provided to participants. It was designed to conceal the urine bag and increase comfort, privacy, and psychosocial well-being. Participants received training on its use and wore it during all daily activities for 21 days.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Individuals aged 18 years or older
* Patients with an indwelling urinary catheter in place for at least 3 weeks
* Ability to communicate and provide informed consent
* Willingness to participate and comply with study procedures

Exclusion Criteria

* Patients with cognitive impairment or communication difficulties
* Presence of active urinary tract infection at the time of enrollment
* Severe physical or psychiatric condition interfering with participation
* Previous participation in a similar catheter-related intervention study
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bahar Ciftci

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Bahar Ciftci

Assistant Professor, Department of Fundamental of Nursing, Atatürk University

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Elazığ State Hospital

Erzurum, Erzurum, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B.30.2.ATA.0.01.00/513

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Discharge Checklist for Stoma Management Skills
NCT07289841 NOT_YET_RECRUITING NA
SH+ and Cash Assistance
NCT07016646 COMPLETED NA
NURSE - LED DIGITAL EDUCATION AND BIGOREXIA
NCT07311005 ENROLLING_BY_INVITATION NA