Clinical trial NCT06569927: Application and Effectiveness of the Perioperative Position Management Based on the ADDIE Model in Patients With Congenital Microtia
Official title: Application and Effectiveness of the Perioperative Position Management Based on the ADDIE Model in Patients With Congenital Microtia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Microtia
Keywords: Congenital microtia
Position management
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 196
Sex: ALL
Minimum age (years): 6
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects were grouped based on admission time to avoid contamination between groups, with data collection for the intervention group conducted after the control group.
Primary purpose: PREVENTION

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 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.

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 group（98 cases）and control group （98 cases）in 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of congenital microtia according to the "Chinese Plastic Surgery" criteria, and undergoing ear reconstruction.
* No other severe comorbidities.

Exclusion Criteria:

* Abnormal coagulation function.
* Presence of eczema or infection on the affected side.
* Severe cognitive impairment or mental illness.
* Patient or family disagrees with the study.

Primary outcomes:
measure: Ear Reconstruction Effectiveness Scale
timeFrame: 3 months postoperatively.
measure: Incidence of skin and flap-related complications after ear reconstruction
timeFrame: 3 months postoperatively.
Secondary outcomes:
measure: Quality of Life Scale for Congenital External and Middle Ear Malformation Patients
timeFrame: Within 24 hours prior to discharge.
measure: Northwick Park Neck Pain Questionnaire (NPQ)
timeFrame: Within 24 hours prior to discharge.
measure: Screen for Child Anxiety Related Emotional Disorders (SCARED)
timeFrame: Within 24 hours prior to discharge.
measure: Self-Rating Anxiety Scale (SAS)
timeFrame: Within 24 hours prior to discharge.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eye & ENT Hospital, Fudan University
state: Shanghai
Study officials:
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