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: October 9, 2014
Last verified: October 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
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, see Learn About Clinical Studies.

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: October 9, 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 October 20, 2014