White Anna, Carding Paul, Booth Vicky, McGlashan Julian, Van Stan Jarrad, Logan Pip, Awad Rehab
Centre for Rehabilitation & Ageing Research, Academic Unit of Injury, Recovery and Inflammation Sciences, School of Medicine, University of Nottingham, Nottingham, UK.
Nottingham University Hospitals NHS Trust, Nottingham, UK.
Pilot Feasibility Stud. 2024 May 23;10(1):84. doi: 10.1186/s40814-024-01508-1.
Management of benign vocal fold lesions (BVFLs) is variable with individuals receiving surgery, voice therapy, or a combination of these approaches. Some evidence suggests that the best outcomes may be achieved when patients are offered pre- and post-operative voice therapy in addition to phonosurgery, but what constitutes pre- and post-operative voice therapy is poorly described. The pre- and post-operative voice therapy (PAPOV) intervention has been developed and described according to the TIDieR checklist and Rehabilitation Treatment Specification System (RTSS) for voice. The PAPOV intervention is delivered by specialist speech and language therapists trained in the intervention and comprises 7 essential and 4 additional components, delivered in voice therapy sessions with patients who are having surgery on their vocal folds for removal of BVFLs.
Non-randomised, multicentre feasibility trial with embedded process evaluation.
Forty patients from two sites who are due to undergo phonosurgery will be recruited to receive the PAPOV intervention. Measures of feasibility, including recruitment, retention, and adherence, will be assessed. The feasibility of gathering clinical and cost effectiveness data will be measured pre-treatment, then at 3 and 6 months post-operatively. An embedded process evaluation will be undertaken to explain feasibility findings.
This study will assess the feasibility of delivering a described voice therapy intervention protocol to patients who are undergoing surgery for removal of BVFLs. Findings will be used to inform the development and implementation of a subsequent effectiveness trial, should this be feasible.
This trial has been prospectively registered on ISRCTN (date 4th January 2023), registration number 17438192, and can be viewed here: https://www.isrctn.com/ISRCTN17438192 .
良性声带病变（BVFLs）的治疗方法多样，患者可接受手术、嗓音治疗或两者结合的方式。一些证据表明，除了嗓音外科手术外，若患者在术前和术后接受嗓音治疗，可能会取得最佳疗效，但对于术前和术后嗓音治疗的具体内容描述甚少。术前和术后嗓音治疗（PAPOV）干预措施已根据嗓音的TIDieR检查表和康复治疗规范系统（RTSS）制定并进行了描述。PAPOV干预由接受过该干预培训的专业言语和语言治疗师实施，包括7个基本组成部分和4个附加组成部分，在为切除BVFLs而进行声带手术的患者的嗓音治疗课程中进行。
带有嵌入式过程评估的非随机、多中心可行性试验。
将招募来自两个地点的40名即将接受嗓音外科手术的患者接受PAPOV干预。将评估包括招募、留存率和依从性在内的可行性指标。将在治疗前、术后3个月和6个月测量收集临床和成本效益数据的可行性。将进行嵌入式过程评估以解释可行性研究结果。
本研究将评估向正在接受手术切除BVFLs的患者提供所述嗓音治疗干预方案的可行性。如果可行，研究结果将用于为后续疗效试验的开展和实施提供信息。
本试验已在ISRCTN上进行前瞻性注册（日期为2023年1月4日），注册号为17438192，可在此处查看：https://www.isrctn.com/ISRCTN17438192 。
