Tongue injury among patients with epilepsy undergoing video-encephalographic monitoring

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2020
INTERVENTION: Aim: We plan to investigate the effectiveness of mouthguards to prevent or minimise tongue injury among epilepsy patients who are undergoing VEEG or Stereotactic EEG (SEEG) monitoring. Study Design and Setting: A prospective, randomised controlled intervention study will be conducted from September 2020 to September 2023 in the EMU, Neurology Ward at Royal Prince Alfred Hospital. At the admission to the EMU, patients will be randomised into two groups. Group 1:Standard Care Group will not receive mouthguards. Group 2:Active Care Group will receive mouthguards for application to both upper and lower teeth. All the nurses who will be involved in performing VEEG monitoring will receive training about the study protocol before commencing the research. A training log for the nurses who will be performing the test will be maintained. Procedures: Pre‐application assessment: Trained neurophysiology nurses will interview all patients who are eligible for the study and complete a demographic data form during the EMU admission process. Application of mouthguards: To maintain a standardised mouthguard placement and follow up care process, we will use the following product: 'Commercially available boil and bite' mouthguards. It is a thermoplastic product and is placed in boiling water then formed and moulded to the contours the teeth using the fingers, lips, tongue, and biting pressure. Step 1 (Group2): The nurse will assist the patient in moulding the mouthguards by trimming it to fit the patient's teeth. Step 2: Group1: No mouthguard Group 2: After reducing AEDS, the nurse will apply the mouthguard to the patient's upper and lower teeth. Patient must to wear mouthguard during sleep and intermittently during day time ( e.g. remove ea CONDITION: Injuries and Accidents ‐ Other injuries and accidents Neurological ‐ Epilepsy Tongue injury; ; Tongue injury PRIMARY OUTCOME: The primary outcome under study is the incidence of tongue injury. Most patients have one or two seizures with tongue biting; therefore, We will be recorded up to two injuries per assessment during VEEG or SEEG monitoring. The outcome will be assessed by the data collection form which includes the incidence of tongue injury and the picture of the patient's tongue injury during the monitoring.; ; [The outcome will occur or not occur immediately following an induced seizure daily VEEG or SEEG monitoring. ] INCLUSION CRITERIA: All epilepsy patients with a focal to bilateral tonic‐clonic generalised seizure or generalised seizures are eligible for this study if they are older than 16 years of age and have valid neurologist referrals for VEEG or SEEG monitoring between 2‐7 days SECONDARY OUTCOME: The secondary outcome of interest is the severity of tongue injury among those participants who are injured. The outcome will be score‐based. The tongue assessment tool is designed specifically for this study and will collect information on the location and severity of tongue injury. Tongue injury will be graded from 1 (erythema) to 3 (laceration). A total tongue injury score will be yielded for each participant by adding all scores for all tongue injuries. [The outcome will occur or not occur immediately following an induced seizure. If there is an injury, it will be scored at the time. daily during VEEG or SEEG monitoring] The third outcome of interest is patient comfort regarding wearing the mouth guard. A survey consisting of seven self‐reported questions which seek Likert scale responses will be used to assess these questionnaires (Mouth Guard Comfort Questionnaires ). It was designed specifically for this study. [The outcome will be assessed by the survey will be administered on the last day of VEEG or SEEG monitoring. ]
Epistemonikos ID: 2704caa6df831ec447010699f1f33edf5eafd226
First added on: Aug 24, 2024