Study on the Design and Application of Special Semi Recumbent Cushion for Postoperative Patients With Esophageal Cancer
- Conditions
- Esophageal Cancer
- Interventions
- Device: cushion
- Registration Number
- NCT05542680
- Brief Summary
1. transform and produce the authorized utility model invention patent "a special cushion for semi recumbent position".
2. to verify the effect of using special semi recumbent cushion for postoperative patients with esophageal cancer.
- Detailed Description
1. Make application-oriented achievement transformation products to provide new special semi recumbent auxiliary tools for patients with esophageal cancer after operation. Summarize the clinical experience and evidence, sign the project cooperation intention agreement with the manufacturer with production qualification, connect with the professional designer of the manufacturer and refine and improve the design scheme; The angle range, materials, fabrics and connection methods of the semi reclining cushion are closely combined with the clinical treatment and patient needs to meet the effectiveness, comfort and practicality of the patient's application; To produce semi reclining cushion products to provide semi reclining cushion for patients after esophageal cancer surgery that can be adjusted from multiple angles and take into account the skin protection function, which is conducive to preventing and alleviating reflux symptoms, improving the quality of life and reducing the risk of skin stress injury.
2. Implement and evaluate the effectiveness of the special semi reclining cushion after esophageal cancer surgery, apply the product to patients after esophageal cancer surgery, and evaluate the effect.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 134
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 cushion In the intervention group, the special cushion for semi recumbent position was used
- Primary Outcome Measures
Name Time Method Reflux symptoms 1 to 30 days after surgery Reflux Diagnostic Questionnaire RDQ The Reflux Diagnostic Questionnaire includes four symptoms: heartburn, acid reflux, regurgitation, and pain behind the sternum. The frequency and severity of symptoms range from 0 to 5 points. The highest score for symptom frequency and severity is 40 points. A higher score indicates more severe reflux, and a score exceeding 12 points indicates a preliminary diagnosis of gastroesophageal reflux disease
- Secondary Outcome Measures
Name Time Method Postoperative quality of life QLQ-C30 7 days after surgery European Organization for Research and Treatment of Cancer (EORTC): Quality of Life Questionnaire: EORTC QLQ-C30
The Quality of Life Questionnaire QLQ-C30 is a tool for assessing the quality of life of cancer patients, with 30 items divided into 15 domains. The scoring method is as follows:
For items 29 and 30, score from 1 to 7 according to the answer options; for other items, score from 1 to 4 according to the answer options .
Add up the scores of the items included in each domain and divide by the number of items included, to get the raw score of that domain .
Use the range method to perform a linear transformation, converting the raw score into a standardized score between 0 and 100 .
For functional domains and overall health status/quality of life domain, the higher the score, the better the functional status and quality of life; for symptom domains, the higher the score, the more symptoms or problems (the lower the quality of life) .Postoperative quality of life QLQ-OES18 7 days after surgery European Organization for Research and Treatment of Cancer (EORTC): Esophagus-specific QOL questionnaire: EORTC QLQ-OES18
QLQ-OES18 is a module for assessing the quality of life of patients with esophageal cancer, which needs to be used together with the QLQ-C30 core questionnaire, with 18 items divided into 10 domains. The scoring method is as follows:
For all items, score from 1 to 4 according to the answer options . Add up the scores of the items included in each domain and divide by the number of items included, to get the raw score of that domain .
Use the range method to perform a linear transformation, converting the raw score into a standardized score between 0 and 100 .
For functional domains and overall health status/quality of life domain, the higher the score, the better the functional status and quality of life; for symptom domains, the higher the score, the more symptoms or problems (the lower the quality of life) .Skin pressure injury 7 to 180 days after surgery The staging standard of pressure injury published by the national pressure sore Advisory Committee of the United States was applied to skin pressure injury
Trial Locations
- Locations (1)
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, China