- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02018471
Psychological Counselling in Diagnostic Screening
Management of Anxiety Related to Diagnostic Screenings: an Exploratory Pilot Study
Descripción general del estudio
Descripción detallada
The Psychoeducative Training was organized in 6 weekly meetings lasting two hours. Each group was composed of 6 participants. The Training follows the cognitive-behavioural model. In the first part of every meeting, theoretical aspects about stress and anxiety were explained, while in the second part some relaxation techniques were taught. During relaxation, we used a selected music that was also going to be used during the diagnostic tests. Since the first meeting, patients experienced these relaxing techniques in order to learn them. In order to support the adaptability, at the end of every meeting the participants received some homework. They had to take notes on how many times they repeated the relaxation exercises and on the anxiety level before and after the training.
For the study, 43 people were recruited. Anxiety was measured with Beck Anxiety Inventory (BAI); it values the seriousness of the physiological behaviour connected with anxiety. This test an "anxiety gauge", which allows us to obtain numerical data on emotional changes. The test is composed of 4 interpretative levels: serious, moderate, small and minimal anxiety.
The coping style was measured with Coping Orientation to Problems Experienced-New Italian Version (COPE-NIV); this test evaluates the way in which people resolve and face traumatic or usual stressful situations.
The research project was approved by the Ethics Committee of Veneto Institute of Oncology.
Every patient signed a written informed consent to process the data for research purposes and to publish it.
Forty-three patients who had to undergo one or more diagnostic tests (PET, TAC, fMRI, Mammography, Endoscopy, Colonoscopy) took part in the study. The average age was 52.4 and 61.5% were married.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- age: 25 to 65 years cancer patients who must undergo diagnostic tests: TAC, PET, fMRI, Mammography, Endoscopy and Colonoscopy.
- an anxiety level greater than 5 (in a scale from 0=very calm to 10=very anxious; using a self-reporting instrument created ad hoc)
- signed informed consent
Exclusion Criteria:
- healthy people
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Pilot group
Forty-three patients who had to undergo one or more diagnostic tests (PET, TAC, fMRI, Mammography, Endoscopy, Colonoscopy) took part in the study.
Most of the 43 patients had to undergo only one diagnostic test, and only 6 patients had more than one.
They have attended a psychoeducative training.
|
The Psychological education was inspired by the technique, Systematic Desensitization (SD), a therapeutic procedure that seeks to eliminate fear and avoidance behaviour
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Proportion of patients considered drop-outs
Periodo de tiempo: 6 weeks after recruitment (end of treatment)
|
The proportion of patients considered drop-outs.
A patient is considered a drop-out if he/she does not attend at least 2 out of 6 programmed meetings.
This is a feasibility outcome
|
6 weeks after recruitment (end of treatment)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
median BAI score after intervention
Periodo de tiempo: 6 weeks after recruitment (end of treatment)
|
This is an efficacy outcome
|
6 weeks after recruitment (end of treatment)
|
median COPE score - Social support score after intervention
Periodo de tiempo: 6 weeks after recruitment (end of treatment)
|
This is an efficacy outcome
|
6 weeks after recruitment (end of treatment)
|
median COPE score - Avoidance strategies score after intervention
Periodo de tiempo: 6 weeks after recruitment (end of treatment)
|
This is an efficacy outcome
|
6 weeks after recruitment (end of treatment)
|
median COPE score - Positive attitude score after intervention
Periodo de tiempo: 6 weeks after recruitment (end of treatment)
|
This is an efficacy outcome
|
6 weeks after recruitment (end of treatment)
|
median COPE score - Problem acceptance score after intervention
Periodo de tiempo: 6 weeks after recruitment (end of treatment)
|
This is an efficacy outcome
|
6 weeks after recruitment (end of treatment)
|
recruitment time (process)
Periodo de tiempo: 6 weeks after recruitment (end of treatment)
|
This is a feasibility outcome
|
6 weeks after recruitment (end of treatment)
|
mean number of recruited patients per week (process)
Periodo de tiempo: 6 weeks after recruitment (end of treatment)
|
This is a feasibility outcome
|
6 weeks after recruitment (end of treatment)
|
refusal rate among eligible patients (process)
Periodo de tiempo: 6 weeks after recruitment (end of treatment)
|
This is a feasibility outcome
|
6 weeks after recruitment (end of treatment)
|
rate of patients who obviously meet and do not meet the eligibility requirements (process)
Periodo de tiempo: 6 weeks after recruitment (end of treatment)
|
This is a feasibility outcome
|
6 weeks after recruitment (end of treatment)
|
number of questionnaires correctly filled out (process)
Periodo de tiempo: 6 weeks after recruitment (end of treatment)
|
This is a feasibility outcome
|
6 weeks after recruitment (end of treatment)
|
phone lines overloaded or waiting room overcrowded by study participants (management)
Periodo de tiempo: 6 weeks after recruitment (end of treatment)
|
This is a feasibility outcome
|
6 weeks after recruitment (end of treatment)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Malihe Shams, Istituto Oncologico Veneto IRCCS
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- IOV-2012 ANXIETY
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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