- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07538752
The Effect of Continuous Care Model on Psychological Distress and Quality of Life Among Postmenopausal Women With Urinary Incontinence
The Effect of Continuous Care Model on Psychological Distress and Quality of Life Among Postmenopausal Women With Urinary Incontinence: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Background: Urinary incontinence is a common problem experienced by postmenopausal women, which greatly impacts their psychological state and quality of life. Although urinary incontinence is a common problem, it is often underreported.
Aim: This research aimed to evaluate the effect of continuous care model on psychological distress and quality of life among postmenopausal women with urinary incontinence.
Design: A Randomized Controlled Trial with pre-test and post-test assessments in both intervention and control groups was conducted.
Setting: The present research was conducted in Egypt, Gharbia Governorate, Tanta city, at gynecological outpatient clinics of Tanta University Hospital and El-Menshawy Hospital.
Tools: A structured interviewing questionnaire, Kessler Psychological Distress Scale, Incontinence Impact Questionnaire (IIQ-7), and incontinence severity index.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Abu Dies
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East Jerusalem, Abu Dies, Palestinian Territories, 51000
- Al-Quds University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women diagnosed with urinary incontinence during the postmenopausal phase
- Women having the ability to read and write.
Exclusion Criteria:
- Women with diabetic nephropathy.
- Women with previous central nervous system injuries.
- Women with bladder cancer.
- Women with urinary tract infections,
- Women with other significant neurological disorders.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intervention group, which received the continuous care model.
The study examined the effects of the intervention ( continuous care model) on the psychological distress and quality of life of postmenopausal women who experienced urinary incontinence.
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Continuous care model promotes ongoing, valuable, and consistent dialogue between nurses and women with urinary incontinence in order to identify their needs and preferences and supports them in embracing healthier habits by providing tailored information and structured guidance. This approach aids women in gaining accurate knowledge about their conditions and empowers them to take charge of their health by proactively addressing their own health issues. The model encourages women to participate in developing their care plan, taking ownership of monitoring their health continuously, and averting potential complications. The main objective of providing nursing care for urinary incontinence is to maintain the woman's continence and support her in carrying out daily activities despite the limitations caused by the condition. Recognizing that women often keep urinary incontinence issues private and avoid seeking healthcare, screening programs are vital in identifying urinary incontinence |
|
No Intervention: Control group (no intervention)
The control group was provided with standard care at the outpatient clinics but did not receive the Continuous Care Model sessions.
They were assessed at the same time as the intervention group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological distress
Time Frame: 6 months
|
Psychological distress was measured using the Kessler Psychological Distress Scale (K10), a frequently used self-report tool for assessing symptoms of anxiety and depression.
The K10 scale consists of 10 items, with each item rated on a 5-point Likert scale ranging from "none of the time" (1) to "all of the time" (5), yielding a total score between 10 and 50, indicating that higher scores signify greater psychological distress.
The results are commonly interpreted using categorized thresholds: scores between 10 and 19 indicate a low likelihood of psychological distress, 20-24 suggest mild distress, 25-29 indicate moderate distress, and scores between 30 and 50 reflect severe psychological distress.
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6 months
|
|
Women' quality of life.
Time Frame: 6 months
|
The IIQ-7 was adopted from Uebersax et al., (1995) and specifically designed to evaluate the influence of UI on women' quality of life.
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urination Disorders
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Urinary Incontinence
Other Study ID Numbers
- Al-Quds University
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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