Ostomy Belt Use Associated Quality of Life

Not Applicable

Completed

• Conditions: Stoma Colostomy; Stoma Ileostomy
• Interventions: Device: Ostomy belt

• Registration Number: NCT04715893
• Lead Sponsor: University of Miami

Brief Summary

The objective of this study is to elucidate whether the use of an ostomy belt can improve the quality of life in patients with an ostomy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-01-14
• Study First Posted: 2021-01-20
• Study Start: 2021-02-22
• Status Verified: 2024-02
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Current patients at University of Miami Hospital with stoma willing to trial an ostomy belt
• 18 - 70 years old
• Willing and able to sign informed consent

Exclusion Criteria

• Patients without stoma or unwilling to wear ostomy belt.
• Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ostomy belt group	Ostomy belt	Participants in this group will receive ostomy belts for eight weeks.

Primary Outcome Measures

Name	Time	Method
Change in quality of life as measured by SQOLS	Baseline to 4 weeks, baseline to 8 weeks post ostomy belt use	Quality of life will be assessed using the Stoma Quality of Life Scale questionnaire (SQOLS) with a range in score from 0 to 100 in overall satisfaction in life with a higher score indicating higher satisfaction.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States