Clinical trial NCT04688047: Urinary Incontinence and Transtheoretical Model
Official title: Urinary Incontinence and Transtheoretical Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: Urinary Incontinence
transtheoretical model
motivational interviewing
nursing care
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 59
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: prevalence of urinary incontinence
timeFrame: Pre-interview (baseline) and last-interview 3 months after pre-interview (change from baseline at 3 months)
measure: severity of urinary incontinence
timeFrame: Pre-interview (baseline) and last-interview 3 months after pre-interview (change from baseline at 3 months)
Secondary outcomes:
measure: Quality of life due to urinary incontinence
timeFrame: Pre-interview (baseline) and last-interview 3 months after pre-interview (change from baseline at 3 months)
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Family Health Centers
Study officials:
affiliation: Gazi University
name: Ayten Senturk Erenel, Prof.
role: STUDY_DIRECTOR
References: