Cancer Clinical Trial
— SNOEZELENOfficial title:
Study Comparing Satisfaction of Hospitalized Patients Receiving Invasive Care for Cancer Treatment, With Snoezelen Session Versus Standard Care (SNOEZELEN)
Verified date | September 2023 |
Source | Institut de cancérologie Strasbourg Europe |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a monocentric, comparative, open-label, randomized, crossover study enrolling patients hospitalized in Strasbourg Europe Cancerology Institute, receiving repeated invasive care for cancer treatment. The purpose of this study is to compare the satisfaction of patients, regarding their perception of care, with or without Snoezelen session.
Status | Completed |
Enrollment | 60 |
Est. completion date | September 18, 2023 |
Est. primary completion date | September 18, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients treated for cancer and hospitalized for invasive care - Two programmed hospitalization for repeated care - Patients receiving one of the following invasive care: Huber needle application (transfusion, parenteral nutrition), complex wound dressing, intrathecal chemotherapy, ascites fluid or pleural puncture - Patients must be = 18 years old - Performance Status = 3 - Absence of psychiatric disorder impairing follow-up - Ability to speak, understand, write and read French - Signed informed consent from the patient - Affiliation to social security system Exclusion Criteria: - Patients presenting infectious symptoms requiring isolation - Patients < 18 years old or patients = 18 years old under supervision - Patients placed under judicial protection or guardianship - Women that are pregnant or breast-feeding |
Country | Name | City | State |
---|---|---|---|
France | Institut de cancérologie Strasbourg Europe | Strasbourg |
Lead Sponsor | Collaborator |
---|---|
Institut de cancérologie Strasbourg Europe |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient satisfaction regarding their perception of care quality (with or without Snoezelen session) at Visit 1 | Evaluation using a modified Visual Analog Scales, Oberts, 1984 | immediately after invasive care at Visit 1 | |
Primary | Patient satisfaction regarding their perception of care quality (with or without Snoezelen session) at Visit 2 | Evaluation using a modified Visual Analog Scales, Oberts, 1984 | immediately after invasive care at Visit 2 | |
Secondary | Change in patient perceived pain, with or without Snoezelen session | Numeric visual analog scale (0 to 10) | At admission (i.e. before Snoezelen session, if applicable) and immediately after invasive care at Visit n°1; At admission (i.e. before Snoezelen session, if applicable) and immediately after invasive care at Visit n°2 | |
Secondary | Change in patient perceived anxiety, with or without Snoezelen session | Numeric visual analog scale (0 to 10) | At admission (i.e. before Snoezelen session, if applicable) and immediately after invasive care at Visit n°1; At admission (i.e. before Snoezelen session, if applicable) and immediately after invasive care at Visit n°2 | |
Secondary | Comparing relationship between patient and caregiver, with or without Snoezelen session | Numeric visual analog scale (0 to 10) | immediately after invasive care at Visit 1 ; immediately after invasive care at Visit 2 |
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