Physical Activity, Kinesiophobia, and Stoma Compliance in Urostomy Patients

August 2, 2024 updated by: Emine Cihan, Selcuk University

Investigation of Physical Activity, Kinesiophobia, and Stoma Compliance in Patients Undergoing Urostomy for Bladder Cancer

In this study, it is aimed to determine the level of physical activity, to investigate kinesiophobia, to determine compliance with the stoma and to compare with healthy controls in patients with bladder cancer who have undergone urostomy surgery and live with a stoma.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Selçuklu
      • Konya, Selçuklu, Turkey, 42130
        • Selcuk University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients using ostomy after Urostomy Surgeries for Bladder Cancer

Description

Inclusion Criteria:

  • The patient group will include people between the ages of 40-75 who underwent urostomy surgery and a stoma after being diagnosed with bladder cancer.
  • The control group will include age-matched healthy people with similar age, body weight and height, without a previous history of cancer.

Exclusion Criteria:

  • Orthotopic surgeries will not be included in the patient group
  • Being under the age of 40,
  • Being diagnosed with lymphedema,
  • Presence of active metastasis,
  • Neurological pathologies that limit voluntary mobility,
  • Orthopedic and cardiovascular pathologies,
  • Having a learning disability or other cognitive or communication impairment.
  • The control group will be excluded if they have any history of cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control Group
Other: survey evaluation
assessment of physical activity, fear of movement, and ostomy compliance
Urostomy Patients Group
Other: survey evaluation
assessment of physical activity, fear of movement, and ostomy compliance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Physical Activity Questionnaire Short Form (IPAQ-SF)
Time Frame: 10 minutes
To assess physical activity levels in METs
10 minutes
Tampa Kinesiophobia Scale
Time Frame: 10 minutes
assess fear of movement in patients
10 minutes
Ostomy Compliance Scale
Time Frame: 10 minutes
Determination of psychosocial adaptation levels of individuals with ostomy to ostomy
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Selcuk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 2, 2024

Primary Completion (Estimated)

August 30, 2024

Study Completion (Estimated)

September 15, 2024

Study Registration Dates

First Submitted

August 2, 2024

First Submitted That Met QC Criteria

August 2, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 2, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/07.25

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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