Use of a Fabric Mattress Cover for Patient Comfort

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01545089
First received: February 29, 2012
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

The main objective of this research project is to measure the impact on patient satisfaction of the use of a fabric mattress cover fabric on a bedsheet protecting a plastic mattress.


Condition Intervention
Patient Comfort
Other: Mattress protector for days 1 and 2
Other: Mattress protector for days 3 and 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Use of a Fabric Mattress Cover for Patient Comfort

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Visual analog scale for patient comfort [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    score ranging from 0 to 10

  • Visual analog scale for patient comfort [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    score ranging from 0 to 10


Enrollment: 174
Study Start Date: June 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mattress protector days 1,2
A mattress protector is placed in the bed for the first two days and then removed for days 3 and 4.
Other: Mattress protector for days 1 and 2
A mattress protector is placed in the bed for the first two days and then removed for days 3 and 4.
Experimental: Mattress protector days 3,4
A mattress protector is not placed in the bed for the first two days and then added to the bed for days 3 and 4.
Other: Mattress protector for days 3 and 4
A mattress protector is not placed in the bed for the first two days and then added to the bed for days 3 and 4.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient has a planned hospitalization > 4 days
  • The patient is "movable" within 48 hours

Exclusion Criteria:

  • The patient is participating in another study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient is pregnant
  • The patient is breastfeeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01545089

Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, Gard, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Luc Duwig, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01545089     History of Changes
Other Study ID Numbers: LOCAL/2011/LD-02, 2011-A01595-36
Study First Received: February 29, 2012
Last Updated: March 3, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

ClinicalTrials.gov processed this record on April 15, 2014