Study Comparing Satisfaction of Hospitalized Patients Receiving Invasive Care for Cancer Treatment, With Snoezelen Session Versus Standard Care

Cancer Clinical Trial

— SNOEZELEN  

Official title:

Study Comparing Satisfaction of Hospitalized Patients Receiving Invasive Care for Cancer Treatment, With Snoezelen Session Versus Standard Care (SNOEZELEN)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04783363
• Other study ID #: 2020-012
• Status: Completed
• Phase: N/A
• Start date: April 12, 2021
• Est. completion date: September 18, 2023

Study information

• Verified date: September 2023
• Source: Institut de cancérologie Strasbourg Europe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Snoezelen session
before one of two repeated invasive care

Locations

Country	Name	City	State
France	Institut de cancérologie Strasbourg Europe	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Institut de cancérologie Strasbourg Europe

Country where clinical trial is conducted

France, 

Outcome

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