Use of a Fabric Mattress Cover for Patient Comfort

March 25, 2015 updated by: Centre Hospitalier Universitaire de Nīmes
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Gard
      • Nîmes Cedex 09, Gard, France, 30029
        • CHU de Nîmes - Hopital Universitaire Caremeau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog scale for patient comfort
Time Frame: 2 days
score ranging from 0 to 10
2 days
Visual analog scale for patient comfort
Time Frame: 4 days
score ranging from 0 to 10
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

February 29, 2012

First Submitted That Met QC Criteria

February 29, 2012

First Posted (ESTIMATE)

March 6, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 26, 2015

Last Update Submitted That Met QC Criteria

March 25, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • LOCAL/2011/LD-02
  • 2011-A01595-36 (OTHER: RCB number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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