Psychological Counselling in Diagnostic Screening
Management of Anxiety Related to Diagnostic Screenings: an Exploratory Pilot Study
Przegląd badań
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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.
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The Psychological education was inspired by the technique, Systematic Desensitization (SD), a therapeutic procedure that seeks to eliminate fear and avoidance behaviour
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Proportion of patients considered drop-outs
Ramy czasowe: 6 weeks after recruitment (end of treatment)
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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
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6 weeks after recruitment (end of treatment)
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
median BAI score after intervention
Ramy czasowe: 6 weeks after recruitment (end of treatment)
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This is an efficacy outcome
|
6 weeks after recruitment (end of treatment)
|
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median COPE score - Social support score after intervention
Ramy czasowe: 6 weeks after recruitment (end of treatment)
|
This is an efficacy outcome
|
6 weeks after recruitment (end of treatment)
|
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median COPE score - Avoidance strategies score after intervention
Ramy czasowe: 6 weeks after recruitment (end of treatment)
|
This is an efficacy outcome
|
6 weeks after recruitment (end of treatment)
|
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median COPE score - Positive attitude score after intervention
Ramy czasowe: 6 weeks after recruitment (end of treatment)
|
This is an efficacy outcome
|
6 weeks after recruitment (end of treatment)
|
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median COPE score - Problem acceptance score after intervention
Ramy czasowe: 6 weeks after recruitment (end of treatment)
|
This is an efficacy outcome
|
6 weeks after recruitment (end of treatment)
|
|
recruitment time (process)
Ramy czasowe: 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)
Ramy czasowe: 6 weeks after recruitment (end of treatment)
|
This is a feasibility outcome
|
6 weeks after recruitment (end of treatment)
|
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refusal rate among eligible patients (process)
Ramy czasowe: 6 weeks after recruitment (end of treatment)
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This is a feasibility outcome
|
6 weeks after recruitment (end of treatment)
|
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rate of patients who obviously meet and do not meet the eligibility requirements (process)
Ramy czasowe: 6 weeks after recruitment (end of treatment)
|
This is a feasibility outcome
|
6 weeks after recruitment (end of treatment)
|
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number of questionnaires correctly filled out (process)
Ramy czasowe: 6 weeks after recruitment (end of treatment)
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This is a feasibility outcome
|
6 weeks after recruitment (end of treatment)
|
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phone lines overloaded or waiting room overcrowded by study participants (management)
Ramy czasowe: 6 weeks after recruitment (end of treatment)
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This is a feasibility outcome
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6 weeks after recruitment (end of treatment)
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Malihe Shams, Istituto Oncologico Veneto IRCCS
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- IOV-2012 ANXIETY
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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