Evaluation of a Polymeric Plate Derived From Castor Oil to Thermotherapy

Study Overview
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Brief Summary
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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
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In this study, the polymeric plate is prepared using the following procedure: - the water is heated to the boiling temperature - the heater is shut down - the polymeric plate is immersed in water - it rests in the water for 15 minutes - 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.

Official Title
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Evaluation of a Polymeric Plate Derived From Castor Oil to Thermotherapy

Conditions
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Therapeutic Hyperthermia, Thermotherapy, Polymers

Intervention / Treatment
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* Device: Polymeric plate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Good communication and comprehension Skin integrity Exclusion Criteria: Reduced skin sensitivity Disturbance in the central nervous system

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polymeric plate characteristics<br>Evaluation, in the volunteers viewpoint, of the polymeric plate characteristics. | Device: Polymeric plate<br>* Application of the polymeric plate in the shoulder for 20 minutes after warming it for 15 minutes in hot water, initially at boiling temperature.<br>* Other names: PPDCO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptance of the polymeric plate | Acceptance of the polymeric plate by the volunteers. | 2 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapeutic Hyperthermia, Thermotherapy, Polymers, Castor Oil