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“共同努力,绽放更灿烂笑容”:一项关于腺样体切除术后亲子口面部肌功能治疗方案有效性的随机对照研究方案

'Shared efforts, brighter smiles': a protocol for a randomised controlled study on the effectiveness of a parent-child orofacial myofunctional therapy programme post-adenoidectomy.

作者信息

Du Haowei, Zhao Meng, Wei Zhaoxia, Liu Jianhua, Zhao Jianchun, Wang Aimin

机构信息

School of Nursing, Qingdao University, Qingdao, Shandong, China.

Qingdao Caretaker Otolaryngology Head & Neck Surgery Hospital, Qingdao, China.

出版信息

BMJ Open. 2025 May 26;15(5):e095795. doi: 10.1136/bmjopen-2024-095795.

Abstract

INTRODUCTION

Adenoid hypertrophy has a high prevalence in children, often causing early orofacial muscle dysfunction that worsens facial deformities over time. While adenoidectomy (AT) alleviates airway obstruction, it only partially addresses the condition, leaving persistent neuromuscular habits. Orofacial myofunctional therapy is necessary for post-AT recovery but faces challenges such as poor adherence and ineffective parent-child communication. Dyadic interventions, which actively involve both parents and children, have shown advantages in improving treatment adherence and enhancing orofacial muscle function. Evidence suggests that dyadic intervention addresses both the child's recovery needs and the caregiving capacity of parents, offering a more comprehensive solution for long-term intervention. Therefore, our team developed a parent-child dyadic orofacial myofunctional therapy (PCD-OMT) programme, offering insights into its potential application in paediatric healthcare to support comprehensive family-centred care.

METHOD AND ANALYSIS

This two-arm, parallel-design, randomised controlled trial will recruit 80 dyads whose children performed AT from two hospitals in Qingdao, China. Dyads will be randomly allocated to two arms. Dyads randomly assigned to the intervention group will receive the PCD-OMT programme. Dyads randomly assigned to the control group will receive regular care. The primary outcomes are orofacial myofunction in children and parental care abilities. The secondary outcomes are children's engagement and parental functioning. A feasibility and acceptability process will be employed to evaluate the viability in clinical practice. Outcomes will be collected at three checkpoints: baseline (T0), postintervention (T1) and after a 12-week follow-up phase (T2).

ETHICS AND DISSEMINATION

This study was approved by the Ethics Committee of Medical College of Qingdao University (QDU-HEC-2023216). The results will be published in peer-reviewed publications and presented in international conferences.

TRIAL REGISTRATION NUMBER

ChiCTR2400091466.

摘要

引言

腺样体肥大在儿童中发病率很高,常导致早期口面部肌肉功能障碍,随着时间的推移会使面部畸形恶化。虽然腺样体切除术(AT)可缓解气道阻塞,但只能部分解决问题,仍会留下持续的神经肌肉习惯。口面部肌功能治疗对腺样体切除术后的恢复很有必要,但面临着依从性差和亲子沟通无效等挑战。双亲干预积极让父母和孩子都参与其中,在提高治疗依从性和增强口面部肌肉功能方面已显示出优势。有证据表明,双亲干预既能满足孩子的康复需求,又能提升父母的照护能力,为长期干预提供了更全面的解决方案。因此,我们的团队开发了一项亲子双亲口面部肌功能治疗(PCD-OMT)计划,以深入探讨其在儿科医疗保健中的潜在应用,以支持以家庭为中心的全面护理。

方法与分析

这项双臂、平行设计的随机对照试验将从中国青岛的两家医院招募80对其孩子接受了腺样体切除术的双亲。双亲将被随机分配到两组。随机分配到干预组的双亲将接受PCD-OMT计划。随机分配到对照组的双亲将接受常规护理。主要结局是儿童的口面部肌功能和父母的照护能力。次要结局是儿童的参与度和父母的功能。将采用可行性和可接受性流程来评估在临床实践中的可行性。将在三个检查点收集结局数据:基线(T0)、干预后(T1)和12周随访期后(T2)。

伦理与传播

本研究已获得青岛大学医学院伦理委员会批准(QDU-HEC-2023216)。研究结果将发表在同行评审的出版物上,并在国际会议上展示。

试验注册号

ChiCTR2400091466。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/53a4/12107575/a2f3e93fe0e8/bmjopen-15-5-g001.jpg

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