Use of a Fabric Mattress Cover for Patient Comfort

Patient Comfort Clinical Trial

Official title:

Use of a Fabric Mattress Cover for Patient Comfort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01545089
• Other study ID #: LOCAL/2011/LD-02
• Secondary ID: 2011-A01595-36
• Status: Completed
• Phase: N/A
• First received: February 29, 2012
• Last updated: March 25, 2015
• Start date: July 2012
• Est. completion date: March 2013

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Patient Comfort

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scale for patient comfort	score ranging from 0 to 10	2 days	No
Primary	Visual analog scale for patient comfort	score ranging from 0 to 10	4 days	No