Pressure Ulcer PreventionNCT06981962
Nursing Interventions for the Prevention of Pressure Ulcer
A study testing Pressure ulcer prevention program in people with Pressure Ulcer Prevention, run by Hawler Medical University at 1 site in Iraq.
Trial summary
this study is aimed to assess the effectiveness of nursing interventions on the prevention of pressure ulcers among immobile stroke patients Read more about this study
- Who is it for?
- Ages 18 to 73 years
- Conditions the study is for
- Pressure Ulcer Prevention
- What is being tested?
- Pressure ulcer prevention program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteIraq
- Study dates
- 5 Sep 2024to 5 Jun 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 18 to 73 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both gender
- Patients' age ≥ 18 years old.
- Patients who
- are at highly risk for pressure ulcer development.
- Braden scale score ≤ 12
- Are able to communicate clearly
- Provide written informed consent
- Do not participate in another study and do not receive any information regarding pressure ulcer prevention.
Who cannot join
- Patients who have different types of mental problems
- Braden scale score > 12
- Have history of previous pressure ulcer and are unable to respond to verbal commands.
- Patients who work as a health care provider.
- Patients with different stages of pressure ulcer.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Nursing Interventions on the Prevention of Pressure Ulcers Among Immobile Stroke Patients
this study is aimed to assess the effectiveness of nursing interventions on the prevention of pressure ulcers among immobile stroke patients
Read the detailed description
Research question: Question 1: What is the effect of nursing educational interventional program on the prevention of pressure ulcers among immobile stroke patients.
The interventional program will be provided for the patients over a period of two days in the hospital, then the pressure ulcer prevention program will demonstrated by the researcher. The education and demonstration will consist of proper positioning, frequent change of patients' posture to limit or decrease pressure over the skin, skincare, such as maintaining adequate hydration, keep skin clean, prevent excessive dryness of skin, prevent message over bony prominence, and control moisture.
A manual in the form of booklet will be given to the patients and their family caregiver.
- Conditions
- Pressure Ulcer Prevention
- Being tested
- Pressure ulcer prevention program
- Keywords
- Immobile patient, Stroke, Pressure ulcers, Incidence, Nursing Intervention
- Medical subject headings
- Stroke, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure ulcer prevention programOther
Interventions will consist of proper positioning, frequent change of patients' posture to limit or decrease pressure over the skin, skincare, such as maintaining adequate hydration, keep skin clean, prevent excessive dryness of skin, prevent message over bony prominence, and control moisture.
| Study group | Role | What they receive |
|---|---|---|
| Case | Experimental | The case group will receive appropriate pressure ulcer prevention program Receives: Other: Pressure ulcer prevention program |
| Control | No intervention | In this study the control group will not receive pressure ulcer prevention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change the incidence of pressure ulcer
Patients' skin will be assessed for the development of pressure ulcer. A patient who move from high and very high-risk Braden scale score (≤12) to stage one pressure ulcer and above is considered as the occurrence of pressure ulcer event.
Braden scale is a pressure ulcer risk assessment tool which evaluates ulcer formation areas such as elbow, occipital, sacrum, back, and heel and areas of bony prominences. 6 is the lowest total subscale score and 23 is the highest total subscale score. The lower total subscale scores, the higher risk for the development of pressure ulcer'
Measured: 3 weeks follow up after patients discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start5 Sep 2024
- Primary completion5 Mar 2025
- Study completion5 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure Ulcer PreventionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- When the program is delivered, two group of high risk patients for pressure ulcer ( Braden scale score ≤12) will be compared for the development of pressure ulcer. The group that receive the program (64 patients) will compare with group that do not receive program (64 Patients).
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halmat Authman Rasheed, Hawler Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981962
- Sponsor's protocol ID
- Nursing interventions
- Status last verified
- Sep 2025
- First submitted
- 7 May 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Nursing Interventions on the Prevention of Pressure Ulcers Among Immobile Stroke Patients
- ClinicalTrials.gov ID
- NCT06981962
- Acronym / sponsor ID
- Nursing interventions
- Conditions
- Pressure Ulcer Prevention
- Keywords
- Immobile patient, Stroke, Pressure ulcers, Incidence, Nursing Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- 5 Mar 2025 (actual)
- Study completion
- 5 Jun 2025 (actual)
- First posted
- 21 May 2025 (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 study is aimed to assess the effectiveness of nursing interventions on the prevention of pressure ulcers among immobile stroke patients
Detailed description
Research question: Question 1: What is the effect of nursing educational interventional program on the prevention of pressure ulcers among immobile stroke patients.
The interventional program will be provided for the patients over a period of two days in the hospital, then the pressure ulcer prevention program will demonstrated by the researcher. The education and demonstration will consist of proper positioning, frequent change of patients' posture to limit or decrease pressure over the skin, skincare, such as maintaining adequate hydration, keep skin clean, prevent excessive dryness of skin, prevent message over bony prominence, and control moisture.
A manual in the form of booklet will be given to the patients and their family caregiver.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- When the program is delivered, two group of high risk patients for pressure ulcer ( Braden scale score ≤12) will be compared for the development of pressure ulcer. The group that receive the program (64 patients) will compare with group that do not receive program (64 Patients).
| Arm | Type | Receives |
|---|---|---|
| Case | Experimental | Other: Pressure ulcer prevention programThe case group will receive appropriate pressure ulcer prevention program |
| Control | No intervention | –In this study the control group will not receive pressure ulcer prevention program |
Who may qualify
- Ages
- 18 to 73 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Both gender
- Patients' age ≥ 18 years old.
- Patients who
Key exclusion criteria (6 listed)
- Patients who have different types of mental problems
- Braden scale score > 12
- Have history of previous pressure ulcer and are unable to respond to verbal commands.
- Patients who work as a health care provider.
- Patients with different stages of pressure ulcer.
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 |
|---|---|---|
| Pressure ulcer prevention programInterventions will consist of proper positioning, frequent change of patients' posture to limit or decrease pressure over the skin, skincare, such as maintaining adequate hydration, keep skin clean, prevent excessive dryness of skin, prevent message over bony prominence, and control moisture. | Other | Case |
Primary outcome
Change the incidence of pressure ulcer
Time frame: 3 weeks follow up after patients discharge
Patients' skin will be assessed for the development of pressure ulcer. A patient who move from high and very high-risk Braden scale score (≤12) to stage one pressure ulcer and above is considered as the occurrence of pressure ulcer event. Braden scale is a pressure ulcer risk assessment tool which evaluates ulcer formation areas such as elbow, occipital, sacrum, back, and heel and areas of bony prominences. 6 is the lowest total subscale score and 23 is the highest total subscale score. The lower total subscale scores, the higher risk for the development of pressure ulcer'
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 23 Sep 2025.
- Individual participant dataSharing planned: No
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Evaluation of Commercially Available Heel Pads for the Prevention of Pressure Ulcers: An Observational Study of Incidence and Usability in Adult Surgical Patients.
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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 Pressure ulcer prevention program in people with Pressure Ulcer Prevention, run by Hawler Medical University at 1 site in Iraq.
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 8 inclusion and 6 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 23 Sep 2025. 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 Iraq. 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?
Change the incidence of pressure ulcer (time frame: 3 weeks follow up after patients discharge). 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 23 Sep 2025.