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At a glance

ClinicalIndex Comparison Record
N/ACompleted· 196 enrolled
Drug / intervention
Utilization of a perioperative position management protocol for congenital microtia patients based on the ADDIE model.procedure
Likely dose
Not stated in record
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Search/NCT06569927
NCT06569927N/ACompleted

Application and Effectiveness of the Perioperative Position Management Based on the ADDIE Model in Patients With Congenital Microtia

Eye & ENT Hospital of Fudan University·interventional·Posted Aug 26, 2024·Updated Aug 26, 2024

In Brief

A clinical study evaluating Utilization of a perioperative position management protocol for congenital microtia patients based on the ADDIE model. for Congenital Microtia. Completed, enrolled 196 participants across 1 site.

Detailed 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 surgery's 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedAug 26, 2024
Enrollment StartMay 1, 2023
Primary CompletionDec 31, 2023
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 1.8 years ago

Interventions

Utilization of a perioperative position management protocol for congenital microtia patients based on the ADDIE model.procedure

Key elements included formation of a multidisciplinary team,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.