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

NCT ID: NCT06569927

Last Updated: 2024-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Congenital Microtia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
The intervention study used a single-blind design, blinded the subjects, and the patients did not know the specific intervention measures, and did not know whether they were included in the control group or the intervention group.

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Eye & ENT Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Reference Type BACKGROUND

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Other Identifiers

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FNF202312

Identifier Type: -

Identifier Source: org_study_id

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