Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06569927
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Application and Effectiveness of the Perioperative Position Management Based on the ADDIE Model in Patients With Congenital Microtia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Application and Effectiveness of the Perioperative Position Management Based on the ADDIE Model in Patients With Congenital Microtia
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aims and objectives To evaluate the clinical application and effectiveness of a perioperative position management program constructed using the ADDIE model for patients with congenital microtia
Background The primary challenge in auricular reconstruction is the fragility of the reconstructed ear structure necessitating strict avoidance of postoperative pressure to ensure the surgerys effect Clinically this has been found to cause anxiety in patients and their families Some patients maintain a fixed position to avoid pressure on the reconstructed ear which may lead to restricted neck movement and a high risk of pressure-related injuries Therefore a systematic perioperative position management program for patients with congenital microtia is necessary
Methods A quasi-trial design with non-randomized grouping was adopted Using convenience sampling 98 patients with congenital microtia admitted to a tertiary specialized hospital in Shanghai from May to August 2023 were included in the control group and received routine care From September to December 2023 another 98 patients were included in the intervention group receiving a perioperative position management program in addition to routine care Effectiveness was evaluated using the Ear Reconstruction Effectiveness Scale SCARED Quality of Life Scale for Congenital External and Middle Ear Malformation Patients SAS Northwick Park Neck Pain Questionnaire and Position Execution Checklist
Background The primary challenge in auricular reconstruction is the fragility of the reconstructed ear structure necessitating strict avoidance of postoperative pressure to ensure the surgerys effect Clinically this has been found to cause anxiety in patients and their families Some patients maintain a fixed position to avoid pressure on the reconstructed ear which may lead to restricted neck movement and a high risk of pressure-related injuries Therefore a systematic perioperative position management program for patients with congenital microtia is necessary
Methods A quasi-trial design with non-randomized grouping was adopted Using convenience sampling 98 patients with congenital microtia admitted to a tertiary specialized hospital in Shanghai from May to August 2023 were included in the control group and received routine care From September to December 2023 another 98 patients were included in the intervention group receiving a perioperative position management program in addition to routine care Effectiveness was evaluated using the Ear Reconstruction Effectiveness Scale SCARED Quality of Life Scale for Congenital External and Middle Ear Malformation Patients SAS Northwick Park Neck Pain Questionnaire and Position Execution Checklist
Detailed Description:
Auricular reconstruction remains one of the most challenging surgeries due to its delicate structures and potential complications The reconstructed auricle is too fragile to withstand excessive pressure that will cause blood circulation disturbances or even necrosis Clinical observations have noted that patients and their families often experience anxiety due to concerns over complications and the impact on recovery affecting their quality of life Furthermore patients frequently hold their heads in a fixed position to prevent pressure on the reconstructed auricle which results in neck stiffness asymmetry and limited mobility Therefore effective perioperative position management is crucial for improving surgical outcomes and patient prognosis and alleviating negative emotions in patients and their families
In our study we evaluated the clinical usefulness of a perioperative position management program designed using the ADDIE model for patients with microtia The patients were divided into the experimental group98 casesand control group 98 casesin a quasi-experimental design that used non-randomized grouping The experimental group received the perioperative position management program in addition to routine care Key elements included perioperative postural management preoperative sleeping posture adaptability training neck movement training standardization of head position angles and head suspension time during surgery use of protective headrests attention to transfer and handover procedures and specially designed pillows
In our study we evaluated the clinical usefulness of a perioperative position management program designed using the ADDIE model for patients with microtia The patients were divided into the experimental group98 casesand control group 98 casesin a quasi-experimental design that used non-randomized grouping The experimental group received the perioperative position management program in addition to routine care Key elements included perioperative postural management preoperative sleeping posture adaptability training neck movement training standardization of head position angles and head suspension time during surgery use of protective headrests attention to transfer and handover procedures and specially designed pillows
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None