NCT01545089

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 29, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 6, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

8 months

First QC Date

February 29, 2012

Last Update Submit

March 25, 2015

Conditions

Patient Comfort

Outcome Measures

Primary Outcomes (2)

  • Visual analog scale for patient comfort

    score ranging from 0 to 10

    2 days

  • Visual analog scale for patient comfort

    score ranging from 0 to 10

    4 days

Study Arms (2)

Mattress protector days 1,2

EXPERIMENTAL

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

Mattress protector days 3,4

EXPERIMENTAL

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

Interventions

Mattress protector for days 1 and 2OTHER

A mattress protector is placed in the bed for the first two days and then removed for days 3 and 4.

Mattress protector days 1,2
Mattress protector for days 3 and 4OTHER

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.

Mattress protector days 3,4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • The patient is participating in another 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, 30029, France

Location

Study Officials

  • Luc Duwig, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2012

First Posted

March 6, 2012

Study Start

July 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

FR(1)