Study on the Design and Application of Special Semi Recumbent Cushion for Postoperative Patients With Esophageal Cancer
- transform and produce the authorized utility model invention patent "a special cushion for semi recumbent position".
- to verify the effect of using special semi recumbent cushion for postoperative patients with esophageal cancer.
Study Overview
Detailed Description
- 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.
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beijing, China
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria:
- transform and produce the authorized utility model invention patent "a special cushion for semi recumbent position".
- to verify the effect of using special semi recumbent cushion for postoperative patients with esophageal cancer. 1. patients with pathologically confirmed esophageal cancer who underwent thoracoscopic resection and neck anastomosis;
2. age ≥ 18 years old; 3. able to read and fill in the questionnaire independently.
Exclusion criteria:
- cognitive impairment or mental illness;
- complicated with other serious diseases;
- unwilling to participate in this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Group 1
In the intervention group, the special cushion for semi recumbent position was used
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In the intervention group, the special cushion for semi recumbent position was used
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No Intervention: Group 2
Routine nursing intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Reflux symptoms
Time Frame: 1 to 30 days after surgery
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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
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1 to 30 days after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Skin pressure injury
Time Frame: 7 to 180 days after surgery
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The staging standard of pressure injury published by the national pressure sore Advisory Committee of the United States was applied to skin pressure injury
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7 to 180 days after surgery
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Postoperative quality of life QLQ-C30
Time Frame: 7 days after surgery
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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) . |
7 days after surgery
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Postoperative quality of life QLQ-OES18
Time Frame: 7 days after surgery
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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) . |
7 days after surgery
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCC2021C-266
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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