Evaluation of a Polymeric Plate Derived From Castor Oil to Thermotherapy

Not Applicable

Completed

• Conditions: Therapeutic Hyperthermia; Thermotherapy; Polymers
• Interventions: Device: Polymeric plate

• Registration Number: NCT01100541
• Lead Sponsor: University of Sao Paulo

Brief Summary

The objective of this work is to evaluate, from volunteers viewpoint, the usability, comfort, appearance, weight, superficial temperature, and other characteristics of a polymeric plate derived from castor oil developed to thermotherapy.

The volunteers will use polymeric plate as a therapeutic resource in the shoulder area and then fill in, without interference of the researcher, some questions about the characteristics of interest.

Detailed Description

In this study, the polymeric plate is prepared using the following procedure:

1. - the water is heated to the boiling temperature

2. - the heater is shut down

3. - the polymeric plate is immersed in water

4. - it rests in the water for 15 minutes

5. - it is inserted in a wrap

In this condition, the polymeric plate is placed on the shoulder of the volunteer and remains there for 20 minutes.

After application, the volunteer answers the questionnaire containing eight questions on a Likert scale (0 to 10) and an area of observations.

Previous laboratory tests were performed to ensure that the temperature of the polymeric plate will not cause skin burn in this application condition.

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2010-04
• Study First Submitted: 2010-04-06
• Study First Submitted QC: 2010-04-08
• Last Update Submitted: 2010-04-08
• Study First Posted: 2010-04-09
• Last Update Posted: 2010-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Good communication and comprehension
• Skin integrity

Exclusion Criteria

• Reduced skin sensitivity
• Disturbance in the central nervous system

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Polymeric plate characteristics	Polymeric plate	Evaluation, in the volunteers viewpoint, of the polymeric plate characteristics.

Primary Outcome Measures

Name	Time	Method
Acceptance of the polymeric plate	2 weeks	Acceptance of the polymeric plate by the volunteers.

Secondary Outcome Measures

Name	Time	Method
Polymeric plate comfort	2 weeks	Perception of the volunteers about the comfort of the polimeric plate.
Polymeric plate temperature	2 weeks	Perception of the volunteers about the polymeric plate temperature.
Polymeric plate time of heat retention	2 weeks	Perception of the volunteers about the polymeric plate time of heat retention.
Sensation on the superficial touch of the polymeric plate	2 weeks	Perception of the volunteers about the sensation on the superficial touch of the polymeric plate.
Appearance of the polymeric plate	2 weeks	Perception of the volunteers about the appearence of the polymeric plate.
Polymeric plate weight	2 weeks	Perception of the volunteers about the polymeric plate weight.
Polymeric plate practicality	2 weeks	Perception of the volunteers about the polymeric plate practicality.
General observations about the polymeric plate	2 weeks	General comments, suggestions and complaints of the volunteers about the polymeric plate.

Trial Locations

Locations (1)

Interunits postgraduate program in bioengineering; 🇧🇷 Sao Carlos, SP, Brazil