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Use of a Fabric Mattress Cover for Patient Comfort

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01545089
First Posted: March 6, 2012
Last Update Posted: March 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
  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: None (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 ]
    score ranging from 0 to 10

  • Visual analog scale for patient comfort [ Time Frame: 4 days ]
    score ranging from 0 to 10


Enrollment: 174
Study Start Date: July 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Identifier: RCB number )
First Submitted: February 29, 2012
First Posted: March 6, 2012
Last Update Posted: March 26, 2015
Last Verified: March 2015