Urinary Incontinence and Transtheoretical Model

March 17, 2023 updated by: Sevil Cicek Ozdemir, Kutahya Health Sciences University
The aim of the study is to evaluate the effectiveness of nursing care given online to women with urinary incontinence based on the Transtheoretical (Change) Model.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The research was planned as a randomized experimental design with pre-test and post-test control groups. The research will be conducted in Kutahya, Turkey.

A total of seven online interviews will be conducted with the women in the experimental group, one of which is pre-test, one is the last interview where the post-tests are applied, and five of which are motivational. Women in the experimental group were interviewed every 2 weeks and the women will be followed up by phone/mail every 2 weeks. A total of two online interviews will be conducted with women in the control group, one of which is a pre-test interview and one is a final interview where post-tests are applied. No application will be made to women in the control group. All online calls to be made will be conducted via the WhatsApp application.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

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
      • Kutahya, Turkey
        • Kutahya Family Health Centers

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion criteria

  • 18 years or above
  • Diagnosis of urinary incontinence according to the International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF)
  • Mild to moderate incontinence according to the Incontinence Severity Index (ISI)
  • Having a smartphone
  • Using the WhatsApp application
  • Being at one of the stages of pre-contemplation, contemplation, preparation, and action according to the evaluation form for stages of change
  • Volunteering to participate in the study

Exclusion criteria

  • Having risk factors that are thought to affect urinary incontinence (pregnancy; giving birth within the last year; having been diagnosed with recurrent urinary tract infection; having any health problem affecting the muscle and/or nervous system; having been diagnosed with a disease that increases intra-abdominal pressure and causes coughing, such as asthma, chronic obstructive pulmonary disease; using drugs that may cause urinary incontinence, such as diuretics, anticholinergics, antidepressants, antiparkinsonian, antihistamines, sedatives, narcotic analgesics for the past year; having been diagnosed with pelvic organ prolapse; receiving education and treatment for urinary incontinence in the last year)
  • Being at the maintenance stage according to the evaluation form for stages of change
  • Not volunteering to participate in the study

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Women aged 18 and over with urinary incontinence will be taken. A total of seven online interviews will be conducted with the women in the experimental group, one of which is pre-test, one is the last interview where the post-tests are applied, and five of which are motivational. Women in the experimental group were interviewed every 2 weeks and the women will be followed up by phone / mail every 2 weeks.
Behavioral: Nursing care based on the transtheoretical model
Nursing care consists of urinary incontinence training, motivational interview and telephone/mail counseling processes.
No Intervention: Control
Women aged 18 and over with urinary incontinence will be taken. A total of two online interviews will be conducted with women in the control group, one of which is a pre-test interview and one is a final interview where post-tests are applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalence of urinary incontinence
Time Frame: Pre-interview (baseline) and last-interview 3 months after pre-interview (change from baseline at 3 months)
Urinary incontinence according to International Consultation on Incontinence Questionnaire - Short Form
Pre-interview (baseline) and last-interview 3 months after pre-interview (change from baseline at 3 months)
severity of urinary incontinence
Time Frame: Pre-interview (baseline) and last-interview 3 months after pre-interview (change from baseline at 3 months)
Urinary incontinence severity according to Incontinence Severity Index
Pre-interview (baseline) and last-interview 3 months after pre-interview (change from baseline at 3 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life due to urinary incontinence
Time Frame: Pre-interview (baseline) and last-interview 3 months after pre-interview (change from baseline at 3 months)
Quality of life due to urinary incontinence according to incontinence quality of life scale Incontinence quality of life scale scale consists of 22 questions in total. The questions are scored between 1 and 5 points. The minimum value that can be obtained from the scale is 22, the maximum value is 110. It is seen that the higher the score in this scale, the higher the quality of life of the individual.
Pre-interview (baseline) and last-interview 3 months after pre-interview (change from baseline at 3 months)

Collaborators and Investigators

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

Sponsor

Kutahya Health Sciences University

Investigators

  • Study Director: Ayten Senturk Erenel, Prof., Gazi 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 (Actual)

March 22, 2021

Primary Completion (Actual)

September 26, 2021

Study Completion (Actual)

October 28, 2021

Study Registration Dates

First Submitted

December 21, 2020

First Submitted That Met QC Criteria

December 24, 2020

First Posted (Actual)

December 29, 2020

Study Record Updates

Last Update Posted (Actual)

March 20, 2023

Last Update Submitted That Met QC Criteria

March 17, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KutahyaSCO

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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