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Urinary Incontinence and Transtheoretical Model

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Nursing care based on the transtheoretical model
Sponsored by
Kutahya Health Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Urinary Incontinence focused on measuring Urinary Incontinence, transtheoretical model, motivational interviewing, nursing care

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years and over women,
  • Women who urinary incontinence according to International Consultation on Incontinence Questionnaire - Short Form
  • Must be literate,
  • Must be ability to access and use online education via smart phone, tablet or computer,
  • Must not have any communication problems,
  • Agreeing to participate in the research,

Exclusion Criteria:

  • Pregnant or postpartum period,
  • Symptoms of urinary tract infection,
  • Any health problem affecting the muscle and / or nervous system,
  • Having illness and cough may cause urinary incontinence,
  • Using drugs that may cause urinary incontinence such as diuretic, anticholinergic, antidepressant, antiparkinsonian, antihistaminic, sedative, narcotic analgesic
  • Women who do not agree to participate in the research

Sites / Locations

  • Kutahya Family Health Centers

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

prevalence of urinary incontinence
Urinary incontinence according to International Consultation on Incontinence Questionnaire - Short Form
severity of urinary incontinence
Urinary incontinence severity according to Incontinence Severity Index

Secondary Outcome Measures

Quality of life due to urinary incontinence
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.

Full Information

First Posted
December 21, 2020
Last Updated
March 17, 2023
Sponsor
Kutahya Health Sciences University
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1. Study Identification

Unique Protocol Identification Number
NCT04688047
Brief Title
Urinary Incontinence and Transtheoretical Model
Official Title
Urinary Incontinence and Transtheoretical Model
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 22, 2021 (Actual)
Primary Completion Date
September 26, 2021 (Actual)
Study Completion Date
October 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kutahya Health Sciences University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Urinary Incontinence, transtheoretical model, motivational interviewing, nursing care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nursing care based on the transtheoretical model
Intervention Description
Nursing care consists of urinary incontinence training, motivational interview and telephone/mail counseling processes.
Primary Outcome Measure Information:
Title
prevalence of urinary incontinence
Description
Urinary incontinence according to International Consultation on Incontinence Questionnaire - Short Form
Time Frame
Pre-interview (baseline) and last-interview 3 months after pre-interview (change from baseline at 3 months)
Title
severity of urinary incontinence
Description
Urinary incontinence severity according to Incontinence Severity Index
Time Frame
Pre-interview (baseline) and last-interview 3 months after pre-interview (change from baseline at 3 months)
Secondary Outcome Measure Information:
Title
Quality of life due to urinary incontinence
Description
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.
Time Frame
Pre-interview (baseline) and last-interview 3 months after pre-interview (change from baseline at 3 months)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayten Senturk Erenel, Prof.
Organizational Affiliation
Gazi University
Official's Role
Study Director
Facility Information:
Facility Name
Kutahya Family Health Centers
City
Kutahya
Country
Turkey

12. IPD Sharing Statement

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Urinary Incontinence and Transtheoretical Model

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