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Completed

NCT Number: NCT04783363

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de cancérologie Strasbourg Europe

Strasbourg, 67033, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Snoezelen session

Other

before one of two repeated invasive care

Primary outcomes

  1. Patient satisfaction regarding their perception of care quality (with or without Snoezelen session) at Visit 1

    Time frame: immediately after invasive care at Visit 1

    Evaluation using a modified Visual Analog Scales, Oberts, 1984

  2. Patient satisfaction regarding their perception of care quality (with or without Snoezelen session) at Visit 2

    Time frame: immediately after invasive care at Visit 2

    Evaluation using a modified Visual Analog Scales, Oberts, 1984

Secondary outcomes

  1. Change in patient perceived pain, with or without Snoezelen session

    Time frame: 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)

  2. Change in patient perceived anxiety, with or without Snoezelen session

    Time frame: 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)

  3. Comparing relationship between patient and caregiver, with or without Snoezelen session

    Time frame: immediately after invasive care at Visit 1 ; immediately after invasive care at Visit 2

    Numeric visual analog scale (0 to 10)

Sponsors and collaborators

Lead sponsor

Institut de cancérologie Strasbourg Europe

Other

Registry information

Official study title

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

Acronym: SNOEZELEN

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 5, 2021
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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