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

August 22, 2024 updated by: Eye & ENT Hospital of Fudan University

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

196

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200031
        • Eye & ENT Hospital, Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
The intervention group implemented a perioperative position management program for congenital microtia based on the ADDIE model, in addition to routine position care.
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.
No Intervention: Control Group
The control group received routine position care, which included perioperative verbal emphasis on the importance of position by nurses, intraoperative use of hydrocolloid positioning pads to prevent pressure injuries, postoperative nurse monitoring and encouragement of proper positioning, assistance with bed mobility, and guidance on safe ambulation techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ear Reconstruction Effectiveness Scale
Time Frame: 3 months postoperatively.
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
Time Frame: 3 months postoperatively.
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

Outcome Measure
Measure Description
Time Frame
Quality of Life Scale for Congenital External and Middle Ear Malformation Patients
Time Frame: Within 24 hours prior to discharge.
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)
Time Frame: Within 24 hours prior to discharge.
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)
Time Frame: Within 24 hours prior to discharge.
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)
Time Frame: Within 24 hours prior to discharge.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eye & ENT Hospital of Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

August 20, 2024

First Submitted That Met QC Criteria

August 22, 2024

First Posted (Actual)

August 26, 2024

Study Record Updates

Last Update Posted (Actual)

August 26, 2024

Last Update Submitted That Met QC Criteria

August 22, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNF202312

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Congenital Microtia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe