Urinary Incontinence and Transtheoretical Model

Sponsor
Kutahya Health Sciences University (Other)
Overall Status
Completed
CT.gov ID
NCT04688047
Collaborator
(none)
59
1
2
7.2
8.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Nursing care based on the transtheoretical model
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
59 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Urinary Incontinence and Transtheoretical Model
Actual Study Start Date :
Mar 22, 2021
Actual Primary Completion Date :
Sep 26, 2021
Actual Study Completion Date :
Oct 28, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. prevalence of urinary incontinence [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

  2. severity of urinary incontinence [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

Secondary Outcome Measures

  1. Quality of life due to urinary incontinence [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kutahya Family Health Centers Kutahya Turkey

Sponsors and Collaborators

  • Kutahya Health Sciences University

Investigators

  • Study Director: Ayten Senturk Erenel, Prof., Gazi University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sevil Cicek Ozdemir, Research assistant, Kutahya Health Sciences University
ClinicalTrials.gov Identifier:
NCT04688047
Other Study ID Numbers:
  • KutahyaSCO
First Posted:
Dec 29, 2020
Last Update Posted:
Apr 5, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sevil Cicek Ozdemir, Research assistant, Kutahya Health Sciences University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 5, 2022