Study Comparing Satisfaction of Hospitalized Patients Receiving Invasive Care for Cancer Treatment, With Snoezelen Session Versus Standard Care
- Conditions
- Cancer
- Interventions
- Other: Snoezelen session
- Registration Number
- NCT04783363
- Lead Sponsor
- Institut de cancérologie Strasbourg Europe
- Brief Summary
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.
- Detailed Description
Patients will followed during two visits for a repeated invasive care. They will be randomized to two groups in a 1:1 ratio.
Crossover plan and arms are described as follow:
Arm A : Visit 1 with Snoezelen session before invasive care and Visit 2 without Snoezelen session before invasive care (standard care)
Arm B : Visit 1 without Snoezelen session before invasive care (standard care) and Visit 2 with Snoezelen session before invasive care
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm B Snoezelen session * Visit 1: standard care (=without Snoezelen session) before invasive care * Visit 2: with Snoezelen session before invasive care Arm A Snoezelen session * Visit 1: with Snoezelen session before invasive care * Visit 2: standard care (=without Snoezelen session) before invasive care
- Primary Outcome Measures
Name Time Method Patient satisfaction regarding their perception of care quality (with or without Snoezelen session) at Visit 2 immediately after invasive care at Visit 2 Evaluation using a modified Visual Analog Scales, Oberts, 1984
Patient satisfaction regarding their perception of care quality (with or without Snoezelen session) at Visit 1 immediately after invasive care at Visit 1 Evaluation using a modified Visual Analog Scales, Oberts, 1984
- Secondary Outcome Measures
Name Time Method Change in patient perceived pain, with or without Snoezelen session 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 Numeric visual analog scale (0 to 10)
Comparing relationship between patient and caregiver, with or without Snoezelen session immediately after invasive care at Visit 1 ; immediately after invasive care at Visit 2 Numeric visual analog scale (0 to 10)
Change in patient perceived anxiety, with or without Snoezelen session 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 Numeric visual analog scale (0 to 10)
Trial Locations
- Locations (1)
Institut de cancérologie Strasbourg Europe
🇫🇷Strasbourg, France