Informazioni generali
  • Categoria della malattia Malattie mentali / psichiche e comportamentali (BASEC)
  • Fase dello studio N/A (ICTRP)
  • Stato di reclutamento reclutamento non ancora iniziato (BASEC/ICTRP)
  • Luogo dello studio
    Losanna
    (BASEC)
  • Responsabile dello studio Jenny Gentizon, infirmière Ph.D jenny.gentizon@chuv.ch (BASEC)
  • Fonte dati BASEC: Importato da 12.05.2026 ICTRP: Importato da 08.05.2026
  • Ultimo aggiornamento 12.05.2026 15:22
HumRes68135 | SNCTP000006904 | BASEC2026-00713 | NCT05715190

Pilot Study on Auricular Acupuncture (at the Ear Level) in Hospitalized Adults with Borderline Personality Disorder

  • Categoria della malattia Malattie mentali / psichiche e comportamentali (BASEC)
  • Fase dello studio N/A (ICTRP)
  • Stato di reclutamento reclutamento non ancora iniziato (BASEC/ICTRP)
  • Luogo dello studio
    Losanna
    (BASEC)
  • Responsabile dello studio Jenny Gentizon, infirmière Ph.D jenny.gentizon@chuv.ch (BASEC)
  • Fonte dati BASEC: Importato da 12.05.2026 ICTRP: Importato da 08.05.2026
  • Ultimo aggiornamento 12.05.2026 15:22

Descrizione riassuntiva dello studio

This study aims to evaluate an auricular acupuncture program (at the ear level), conducted by nurses, as a complement to usual care, in hospitalized adults in psychiatry for borderline personality disorder. The intervention is based on a standardized protocol from the National Acupuncture Detoxification Association (NADA), also known as "acudetox". Acupuncture is performed by mental health nurses trained as NADA practitioners. In this pilot study, we will recruit 15 patients. The objective is to assess the feasibility of the program in terms of participation in the sessions, as well as its potential impact on several aspects of health, particularly: emotion regulation, relaxation, sleep quality, satisfaction with treatments, clinical severity and evolution, and the use of psychotropic medications. Participation in the study is voluntary and lasts 12 days. Individuals who agree to participate will be invited to: - attend 5 scheduled acupuncture sessions between 4:00 PM and 8:00 PM, spaced 24 hours apart; - have a follow-up visit 2 days after the end of the program; - complete short questionnaires between sessions. All participants will receive acupuncture in addition to the usual care provided by the psychiatric hospital. This care includes medical consultations, medication treatments, as well as support from nurses, physiotherapists, occupational therapists, and social workers. The results of this pilot study will provide essential information on research procedures as well as any necessary adaptations before considering a larger-scale study. Each participant will receive a shopping voucher (20 CHF Migros) at the end of each visit, for a total maximum amount of 120 CHF.

(BASEC)

Intervento studiato

The intervention protocol consists of a short and standardized auricular acupuncture program, administered during psychiatric hospitalization. Participants will receive 5 individual acupuncture sessions (45 minutes each) over a period of 9 days, scheduled at 24-hour intervals and conducted between 4:00 PM and 8:00 PM. Each session will take place in the patient's hospital room and will be performed by a mental health nurse trained as a NADA practitioner.

 

After a brief explanation of the procedure, participants are comfortably positioned either semi-sitting or lying down. The nurse then prepares the auricular area according to standard hygiene procedures, and inserts sterile single-use needles bilaterally (in both ears) at the five points specified by the NADA protocol. The insertion of the needles lasts about 15 minutes and is performed with minimal verbal interactions, in accordance with the principles of the protocol. This is followed by a silent period of 30 minutes, during which the patient remains alone in a calm and uninterrupted environment. At the end of the session, the nurse removes the needles and conducts a clinical assessment of the skin condition (bleeding, bruising) and documents the procedure.

 

The intervention is not intended to be personalized or adapted at the individual level. All participants will receive the same standardized auricular acupuncture protocol as provided by NADA, applied uniformly during all sessions. Only minor adjustments may be made if necessary (e.g., slight adjustment of needle positioning in case of pain); these do not alter the therapeutic content and do not compromise the integrity of the intervention.

 

All operational adjustments will be documented as deviations from the protocol, specifying their nature and justification.

(BASEC)

Malattie studiate

Borderline Personality Disorder

(BASEC)

Criteri di partecipazione
The study concerns hospitalized adults with a diagnosis of borderline personality disorder, capable of expressing themselves and understanding French, regardless of the ongoing treatment provided at the hospital (psychotherapy, medications, etc.). (BASEC)

Criteri di esclusione
Patients presenting severe agitation, high suicide risk, those hospitalized in isolation rooms, or receiving anticoagulant or immunosuppressive treatment will be excluded from the study. (BASEC)

Luogo dello studio

Losanna

(BASEC)

Switzerland (ICTRP)

Sponsor

Centre hospitalier universitaire vaudois (CHUV) - Bureau Promoteur de la recherche

(BASEC)

Contatto per ulteriori informazioni sullo studio

Persona di contatto in Svizzera

Jenny Gentizon, infirmière Ph.D

+41795568033

jenny.gentizon@chuv.ch

Institut Universitaire de Formation et Recherche en Soins, UNIL/CHUV

(BASEC)

Informazioni generali

University of Applied Sciences and Arts Western Switzerland

(ICTRP)

Informazioni scientifiche

University of Applied Sciences and Arts Western Switzerland

(ICTRP)

Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)

Commissione d'etica Vaud

(BASEC)

Data di approvazione del comitato etico

12.05.2026

(BASEC)


ID di studio ICTRP
NCT05715190 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
Feasibility and preliminary effectiveness of a nurse-led auricular acupuncture intervention in hospitalized adults with borderline personality disorder: a pilot study (BASEC)

Titolo accademico
Development and Feasibility of a Nurse-led Person-centered Education Program on Percentage Reduction of Psoriasis in Persons With Psoriasis: a Pilot Study (ICTRP)

Titolo pubblico
Development and Feasibility of a Nurse-led Person-centered Education Program (ICTRP)

Malattie studiate
Self-ManagementBehaviorPatient Empowerment (ICTRP)

Intervento studiato
Other: Education (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Health Services Research. Masking: None (Open Label). (ICTRP)

Criteri di inclusione/esclusione
Inclusion Criteria:

- Diagnosed cutaneous psoriasis, regardless of the stage of the disease and treatment
type (systemic and/or topic, and/or puva therapy)

- Age over 18 years

- Proficiency in the French language

Exclusion Criteria:

- Valid informed consent is not or cannot be given

- Patients unable to follow the 6-session therapeutic education program

- Patients currently engaged in any other therapeutic education program (ICTRP)

non disponibile

Endpoint primari e secondari
percentage reduction of psoriasi (ICTRP)

Health Literacy;Patient benefit;Life Quality Index;Psoriasis severity;Medication knowledge;Knowledge of psoriasis;Self-management of the disease (ICTRP)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
University of Lausanne Hospitals;University of Lausanne (ICTRP)

Contatti aggiuntivi
Sebastian E Probst, Prof, University of Applied Sciences and Arts Western Switzerland (ICTRP)

ID secondari
Psoriasis (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT05715190 (ICTRP)

Risultati dello studio

Riepilogo dei risultati

non disponibile

Link ai risultati nel registro primario

non disponibile