Effect and safety of listening to music or audiobooks as a coadjuvant treatment for chronic pain patients under opioid treatment: a study protocol for an open-label, parallel-group, randomised, controlled, proof-of-concept clinical trial in a tertiary hospital in the Barcelona South Metropolitan area.

BACKGROUND: Chronic non-cancer pain (CNCP) treatment's primary goal is to maintain physical and mental functioning while improving quality of life. Opioid use in CNCP patients has increased in recent years, and non-pharmacological interventions such as music listening have been proposed to counter it. Unlike other auditive stimuli, music can activate emotional-regulating and reward-regulating circuits, making it a potential tool to modulate attentional processes and regulate mood. This study's primary objective is to provide the first evidence on the distinct (separate) effects of music listening as a coadjuvant maintenance analgesic treatment in CNCP patients undergoing opioid analgesia. METHODS AND ANALYSIS: This will be a single-centre, phase II, open-label, parallel-group, proof-of-concept randomised clinical trial with CNCP patients under a minimum 4-week regular opioid treatment. We plan to include 70 consecutive patients, which will be randomised (1:1) to either the experimental group (active music listening) or the control group (active audiobooks listening). During 28 days, both groups will listen daily (for at least 30 min and up to 1 hour) to preset playlists tailored to individual preferences.Pain intensity scores at each visit, the changes (differences) from baseline and the proportions of responders according to various definitions based on pain intensity differences will be described and compared between study arms. We will apply longitudinal data assessment methods (mixed generalised linear models) taking the patient as a cluster to assess and compare the endpoints' evolution. We will also use the mediation analysis framework to adjust for the effects of additional therapeutic measures and obtain estimates of effect with a causal interpretation. ETHICS AND DISSEMINATION: The study protocol has been reviewed, and ethics approval has been obtained from the Bellvitge University Hospital Institutional Review Board, L'Hospitalet de Llobregat, Barcelona, Spain. The results from this study will be actively disseminated through manuscript publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT05726266.

Estudio sobre infecciones congénitas y perinatales / Study of congenital and perinatal infections

Se estudió 105 neonatos admitidos al Servicio de Neonatología y 36 niños mayores de 1 a 24 meses que ingresaron a otros Servicios del Hospital Nacional de Niños, San José, Costa Rica. Todos ellos presentaban uno o más signos de la sintomatología clásica del Síndrome de TORCHS. En el 13,4 por ciento de los casos se detectó una etiología infecciosa. El agente más comunmente aislado fue el citomegalovirus, en el 52,6 por ciento de los casos. Le siguio la toxoplasmosis, que se determinó por métodos serologicos en cinco pacientes (26,3%); y la sífilis ocupó el tercer lugar (15,5%) detectandose anticuerpos específicos en tres niños estudiados. La inmunoglobulina M específica para el virus de rubéola se detectó en solo uno de los pacientes estudiados. La patología y/o signología presentada por los niños se dividio entre los pacientes con y sin etiologia infecciosa. Se observo diferencias significativas entre los dos grupos en signos como la hepatoesplenomegalia, petequias, anemia, neumonia y microcefalia. Se discute las posibilidades de otras virosis como el sarampión, paperas, varicela-zóster e influenza, como agentes etiológicos de problemas congénitos en Costa Rica. .