NCT06509399

Brief Summary

The aim of this study is to evaluate the effectiveness of the care package (CP) developed to prevent pressure injury (PI) in patients in intensive care and to evaluate the effect of the training given to nurses on their knowledge levels and attitudes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

June 27, 2024

Last Update Submit

July 13, 2024

Conditions

Keywords

Pressure ulcerCare packageIntensive care unitEvidence-based practiceNursing

Outcome Measures

Primary Outcomes (1)

  • Pressure Ulcer Formation

    Ulcer formation was monitored. Patients were followed up for at least 10 days in this respect.

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Knowledge levels of nurses

    through study completion, an average of 1 year

Study Arms (2)

PRESSURE ULCERS PREVENTION CARE PACKAGE IN INTENSİVE CARE UNIT

EXPERIMENTAL

This experimental study was carried out in the anesthesia and reanimation intensive care unit of Düzce Atatürk State Hospital. The part with patients was completed with a total of 72 patients, 36 in the control group and 36 in the application group. The occurrence rate of PI was compared between the control group and the application group.

Other: care package

NURSES' LEVEL OF KNOWLEDGE ABOUT THE CARE PACKAGE

NO INTERVENTION

In the section about nurses, no sample was selected and all 50 nurses working in intensive care were included in the study. Nurses' knowledge and attitudes about PI before and after the training were compared.

Interventions

Before the patients in the application group started to be observed, the nurses working in the clinic were trained about the risk assessment, skin assessment, incontinence management, nutrition assessment, positioning, support surfaces and injuries caused by the devices in the BP content to be used in the prevention of IU. After the trainings given to the nurses were completed, care was given to the patients in the practice group in accordance with BP. In addition, patient information was collected from patient information files, nurse observation forms and hospital automation system. In the evaluation step, full compliance with the 7 compliance steps specified in the BP was sought. If any one of these parameters was incomplete, the others were considered as incomplete. The patients in the control group were followed up for 30 days until the determined number of patients was reached and their data were collected.

PRESSURE ULCERS PREVENTION CARE PACKAGE IN INTENSİVE CARE UNIT

Eligibility Criteria

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

You may qualify if:

  • \- 18 years of age or older,
  • No development of pressure ulcers in any part of the body,
  • Patients expected to stay in the clinic for at least 72 hours or more
  • patients with a braden score below 15 points
  • Obtaining written consent from the first-degree relatives of patients whose written consent is obtained, patients who are unconscious and unable to give consent

You may not qualify if:

  • \- 18 years of age or younger,
  • BY in any part of the body,
  • BBYRDS score more than 15
  • Failure to give written consent by himself/herself or his/her 1st degree relative
  • Exitus, discharge, change of department and the patient's wish to leave the study before completing the number of days determined during the data collection phase

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Abant Izzet Baysal University Faculty of Health Science

Bolu, Merkez, 14100, Turkey (Türkiye)

Location

Bolu Abant İzzet Baysal Üniversitesi/Sağlık Bilimleri Fakültesi

Bolu, 14100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
The part with patients was completed with a total of 72 patients, 36 in the control group and 36 in the application group.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: experimental study randomised controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgical Nursing

Study Record Dates

First Submitted

June 27, 2024

First Posted

July 19, 2024

Study Start

May 15, 2023

Primary Completion

September 15, 2023

Study Completion

September 15, 2023

Last Updated

July 19, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations