NCT05852236

Brief Summary

SUMMARY In a non-randomised (quasi-experimental) clinical study, it was aimed to determine the effect of the care package applied in the early postoperative period on operating theatre pressure sores, pain, fear of falling and comfort in patients undergoing orthopaedic surgery. In the study, the care bundle for pressure injuries was prepared in accordance with the clinical guidelines and was applied to the patients in the study group. This study was conducted in the orthopaedics and traumatology clinic of a public hospital in the Southeastern Anatolia Region of Turkey.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

7 months

First QC Date

April 4, 2023

Last Update Submit

May 1, 2023

Conditions

Keywords

orthopedic surgerypressure injurycare bundlepainfear of fallingcomfort

Outcome Measures

Primary Outcomes (4)

  • The effect of pressure ulcer care package on the incidence of pressure ulcers in patients

    In this study, it was seen that the pressure ulcer care package applied to the study group contributed positively to the change in the incidence rate of pressure ulcers.

    Implementation Time: 3.5 Month

  • The effect of pressure ulcer care package on pain perception in patients

    In this study, it was seen that the pressure ulcer care package applied to the study group made positive contributions to the change of pain level. Visual Analog Scale was used to evaluate the level of pain. The score obtained from the scale ranges from one to ten. The higher the score, the higher the level of pain.

    Implementation Time: 3.5 Month

  • The effect of pressure ulcer care package on fear of falling in patients

    In this study, the pressure ulcer care package applied to the study group changed the fear of falling in patients. Visual Analogue Scale was used to obtain numerical data in the assessment of fear of falling. The score obtained from the scale ranges from one to ten. The higher the score, the greater the fear of falling.

    Implementation Time: 3.5 Month

  • The effect of pressure ulcer care package on comfort in patients

    In this study, the pressure ulcer care package applied to the study group changed the comfort of the patients. The comfort level of the patients was determined by using the short form of the comfort scale. As the score obtained from the scale increases, the level of comfort increases.

    Implementation Time: 3.5 Month

Study Arms (2)

Control Group

EXPERIMENTAL

The standard care of the clinic was applied to the control group.

Other: Assigned Interventions

Study Group

EXPERIMENTAL

The pressure ulcer care package developed for this study was applied to the study group.

Other: Assigned Interventions

Interventions

Pressure ulcer care package application.

Control GroupStudy Group

Eligibility Criteria

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

You may qualify if:

  • years of age or older
  • Orthopaedics and traumatology department
  • Those who have undergone general or spinal anaesthesia
  • No history of surgery in the last month
  • Without any communication problems
  • S Patients with a score of 18 and above on the Operating Theatre Pressure Wound Risk Assessment Scale
  • Patients admitted to the emergency clinic, whose trauma-related surgery is planned within 24 hours from the emergency clinic
  • Admission to the orthopaedics and traumatology clinic within maximum 24 hours from the day of surgery planned as elective surgery
  • Patients who volunteered to participate in the study were included.

You may not qualify if:

  • I'm the one whose surgery was cancelled
  • Those who have undergone local or regional anaesthesia
  • Patients referred to the intensive care unit after surgery
  • Patients who wanted to leave the study after volunteering were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Şehitkamil Devlet Hastanesi

Gaziantep, 27500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pressure UlcerPain

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ayla YAVA, PhD

    Prefessor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Non-Randomized
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse, RN

Study Record Dates

First Submitted

April 4, 2023

First Posted

May 10, 2023

Study Start

July 1, 2021

Primary Completion

January 16, 2022

Study Completion

April 30, 2022

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations