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

NCT06569927 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2024-08-26

No results posted yet for this study

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.

Conditions

  • Congenital Microtia

Interventions

PROCEDURE

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

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.

Sponsors & Collaborators

  • Eye & ENT Hospital of Fudan University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06569927 on ClinicalTrials.gov