NCT06981962

Brief Summary

this study is aimed to assess the effectiveness of nursing interventions on the prevention of pressure ulcers among immobile stroke patients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 5, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 21, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2025

Completed
Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

May 7, 2025

Last Update Submit

September 17, 2025

Conditions

Keywords

Immobile patientStrokePressure ulcersIncidenceNursing Intervention

Outcome Measures

Primary Outcomes (1)

  • 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'

    3 weeks follow up after patients discharge

Study Arms (2)

Case

EXPERIMENTAL

The case group will receive appropriate pressure ulcer prevention program

Other: Pressure ulcer prevention program

Control

NO INTERVENTION

In this study the control group will not receive pressure ulcer prevention program

Interventions

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.

Case

Eligibility Criteria

Age18 Years - 73 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hawler Medical University

Erbil, Kurdistan, 44001, Iraq

Location

MeSH Terms

Conditions

StrokePressure Ulcer

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist professor

Study Record Dates

First Submitted

May 7, 2025

First Posted

May 21, 2025

Study Start

September 5, 2024

Primary Completion

March 5, 2025

Study Completion

June 5, 2025

Last Updated

September 23, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations