Psychological DistressNCT07538752
The Effect of Continuous Care Model on Psychological Distress and Quality of Life Among Postmenopausal Women With Urinary Incontinence
A study testing Continuous Care Model sessions in people with Psychological Distress and Quality of Life and Menopause, run by Al-Quds University at 1 site in Palestinian Territories.
Trial summary
This research aimed to evaluate the effect of continuous care model on psychological distress and quality of life among postmenopausal women with urinary incontinence. Read more about this study
- Who is it for?
- Ages 45 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress, Quality of Life and Menopause
- What is being tested?
- Continuous Care Model sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 1 May 2025to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women diagnosed with urinary incontinence during the postmenopausal phase
- Women having the ability to read and write.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
Al-Quds University
East Jerusalem, Abu Dies, 51000
About this study
Official title: The Effect of Continuous Care Model on Psychological Distress and Quality of Life Among Postmenopausal Women With Urinary Incontinence: A Randomized Controlled Trial
This research aimed to evaluate the effect of continuous care model on psychological distress and quality of life among postmenopausal women with urinary incontinence.
Read the 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.
- Being tested
- Continuous Care Model sessions
- Keywords
- Continuous Care Model, Psychological Distress, quality of life, Urinary Incontinence
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Care Model sessionsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| intervention group, which received the continuous care model. | Experimental | 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. Receives: Behavioral: Continuous Care Model sessions |
| Control group (no intervention) | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological distress
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.
Measured: 6 months
Women' quality of life.
The IIQ-7 was adopted from Uebersax et al., (1995) and specifically designed to evaluate the influence of UI on women' quality of life.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start1 May 2025
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Quds University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraf Jehad Abuejheisheh, Al-Quds University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538752
- Sponsor's protocol ID
- Al-Quds University
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Continuous Care Model on Psychological Distress and Quality of Life Among Postmenopausal Women With Urinary Incontinence: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07538752
- Acronym / sponsor ID
- Al-Quds University
- Keywords
- Continuous Care Model, Psychological Distress, quality of life, Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Al-Quds UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research aimed to evaluate the effect of continuous care model on psychological distress and quality of life among postmenopausal women with urinary incontinence.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group, which received the continuous care model. | Experimental | Behavioral: Continuous Care Model sessionsThe 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. |
| Control group (no intervention) | 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women diagnosed with urinary incontinence during the postmenopausal phase
- Women having the ability to read and write.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Care Model sessionsContinuous 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 | Behavioural | intervention group, which received the continuous care model. |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Psychological Distress
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
Not yet recruiting
Hand in Hand: Feasibility of a Compassion-Focused App to Support Parents of Children With Mental Health Problems
Physiological Conditions, Distress, Emotional
Active, not recruiting
HRVB for Stress and Anxiety During Dentistry Students' Clinical Transition
Stress (Psychology), Anxiety
Recruiting
Effects of a Mindful Self-Compassion Intervention on Psychological Adjustment in Breast Cancer Survivors
Breast Cancer
Not yet recruiting
Group Psychological Intervention to Reduce Distress Among Nursing Undergraduates
Psychological Distress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Care Model sessions in people with Psychological Distress and Quality of Life and Menopause, run by Al-Quds University at 1 site in Palestinian Territories.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Palestinian Territories. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological distress (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.