Application and Effectiveness of the Perioperative Position Management Based on the ADDIE Model in Patients With Congenital Microtia
NCT Number: NCT06569927
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Congenital Microtia
Interventions: PROCEDURE: Utilization of a perioperative position management protocol for congenital microtia patients based on the ADDIE model.
Sponsor: Eye & ENT Hospital of Fudan University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 196
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2023-05-01
Completion Date: 2023-12-31
Locations: Eye & ENT Hospital, Fudan University, Shanghai, Shanghai, 200031, China

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.

Primary Outcome Measures: Ear Reconstruction Effectiveness Scale, Evaluation was conducted using the surgical outcome scoring system developed by Wei Lü. The scale includes five aspects: (1) The size, position, and realism of the reconstructed ear compared to the healthy side (total score 24 points). (2) The angle size and stability of the cranioauricular angle of the reconstructed ear (total score 12 points). (3) The color of the skin of the reconstructed ear and its coordination with the surrounding skin (total score 10 points). (4) The condition of the local scars at the incision behind the ear (total score 9 points). (5) The presentation of the subunit structure of the reconstructed ear (total score 45 points). A total score greater than 85 is rated as excellent; 75-84 is rated as good; 65-74 is rated as fair; and less than 65 is rated as poor. The specific method of use involves plastic surgeons scoring based on the structure of the child's healthy side or the structure of a normal person's auricle., 3 months postoperatively.|Incidence of skin and flap-related complications after ear reconstruction, The researchers independently designed the position execution checklist based on a review of relevant literature. The checklist consists of two parts: (1) Demographic Information: This includes gender, age, education level, and caregivers. (2)Disease-Related Information: This includes the duration of surgery, the side of the surgery, the name of the surgery, instances of reconstructed ear compression, the time period during which the compression occurred, the occurrence of complications, and medication usage., 3 months postoperatively.
Secondary Outcome Measures: Quality of Life Scale for Congenital External and Middle Ear Malformation Patients, This scale is used to assess the quality of life of patients with congenital middle and outer ear deformities, encompassing three dimensions: physical function, psychological state, and social relationships, with a total of 18 items. Each item is rated on a five-point scale from 0 to 4, with a total score ranging from 0 to 80. The higher the score, the poorer the quality of life., Within 24 hours prior to discharge.|Northwick Park Neck Pain Questionnaire (NPQ), This scale is used to assess the function of clinical neck pain patients and consists of 9 items, including pain severity, duration of symptoms, nighttime prickling or numbness, the impact of pain on sleep, social activities, reading, work or household tasks, and driving. If the subject has no driving experience, this item is not scored. Each item is rated on a five-point scale from 0 to 4, with a total score ranging from 0 to 36. The higher the score, the more severe the neck pain., Within 24 hours prior to discharge.|Screen for Child Anxiety Related Emotional Disorders (SCARED), This scale is used for self-assessment of anxiety disorders in children and adolescents aged 8-16. It includes five factors: somatization/panic, generalized anxiety, separation anxiety, social phobia, and school phobia, with a total of 41 items. Each item is scored on a three-point scale from 0 to 2. 0: no problem; 1: sometimes; 2: often. The higher the score, the more severe the anxiety., Within 24 hours prior to discharge.|Self-Rating Anxiety Scale (SAS), This scale is used to assess subjective feelings of anxiety and consists of 20 items. Each item is scored on a four-point scale. Five items (items 5, 9, 13, 17, 19) are positively worded, while the remaining 15 items are negatively worded. Patients' families use the Self-Rating Anxiety Scale (SAS) for evaluation, with scores interpreted as follows: less than 50 indicates no anxiety, 50-59 indicates mild anxiety, 60-69 indicates moderate anxiety, and greater than 69 indicates severe anxiety. Higher scores reflect more severe anxiety., Within 24 hours prior to discharge.