Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447298
Status:
COMPLETED
Last Update Posted:
2024-06-28
First Post:
2024-06-03
Brief Title:
Evaluation of the Satisfaction of Parents Accompanying Children Who Have Undergone Laparoscopic Surgery
Sponsor:
University Hospital Brest
Organization:
University Hospital Brest
Study Overview
Official Title:
Evaluation of the Satisfaction of Parents Accompanying Children Who Have Undergone Laparoscopic Surgery
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COELIOCOM
Brief Summary:
An increasing number of surgeries are being performed using laparoscopic techniques This approach significantly reduces postoperative pain and speeds up recovery Additionally the resulting scars are smaller compared to open surgeries This study evaluates the quality of care and communication satisfaction among parents of children undergoing laparoscopic surgery in the pediatric surgery department of Brest The primary goal is to assess parental satisfaction with communication during the procedure Parents of children who have undergone laparoscopic surgery will be invited to participate Participants will complete a satisfaction questionnaire the day after surgery and participate in a follow-up phone interview 7 to 9 days post-surgery incorporating the childs opinion if possible
Detailed Description:
Laparoscopic surgery also known as laparoscopy and thoracoscopy is increasingly used in pediatric surgery This technique involves performing procedures through small incisions using miniaturized instruments and a camera allowing precise real-time operation Laparoscopy offers several advantages over traditional open surgery such as reduced surgical trauma shorter recovery times smaller scars and lower risks of complications like infections and bleeding Despite these benefits research on patient experience with laparoscopy is limited particularly regarding communication between patients and healthcare teams This study aims to assess the satisfaction of parents whose children undergo laparoscopic surgery focusing on communication and care quality Previous studies indicate that patient satisfaction is a critical independent measure of care quality not necessarily linked to clinical outcomes Enhancing patient satisfaction can also reduce postoperative complications and improve recovery
Using a custom satisfaction questionnaire based on the standardized and validated PedsQL generic care satisfaction questionnaire this study will evaluate parental satisfaction with communication and care regarding their childs laparoscopic surgery Parents will complete a satisfaction questionnaire the day after surgery and participate in a follow-up phone interview 7 to 9 days post-surgery considering the childs input if possibleUsing a Likert scale each of the 20 items in the questionnaire will be evaluated with a score between 0 not at all satisfied and 5 totally satisfied Then the sum of the scores for each item will be calculated to obtain an overall score between 0 not at all satisfied and 100 totally satisfied
The primary objective of this study is to evaluate parental satisfaction with communication after their childs laparoscopic surgery by averaging the satisfaction scores from the initial post-laparoscopy questionnaire and the follow-up telephone interview scored from 0 to 100
For secondary objectives responses to open-ended questions during the telephone interview will be qualitatively analyzed to gain insights into specific aspects of the parental experience with laparoscopy The quality of care will be assessed using scores from specific items on the questionnaires related to care quality Additionally the study will analyze the duration of hospitalization to explore any correlation with parental satisfaction The evolution of satisfaction over time will be assessed by comparing initial satisfaction scores with short-term satisfaction scores obtained during the follow-up interview This comparison aims to identify any changes in satisfaction levels particularly concerning the post-discharge period All data will be analyzed using descriptive statistics for frequency and mean scores with further analysis conducted using the software Prism to ensure robustness and validity of the findings
At the end of this study investigators hope to identify areas for improvement in surgical care and communication aiming to enhance the postoperative quality of life for pediatric patients
Using a custom satisfaction questionnaire based on the standardized and validated PedsQL generic care satisfaction questionnaire this study will evaluate parental satisfaction with communication and care regarding their childs laparoscopic surgery Parents will complete a satisfaction questionnaire the day after surgery and participate in a follow-up phone interview 7 to 9 days post-surgery considering the childs input if possibleUsing a Likert scale each of the 20 items in the questionnaire will be evaluated with a score between 0 not at all satisfied and 5 totally satisfied Then the sum of the scores for each item will be calculated to obtain an overall score between 0 not at all satisfied and 100 totally satisfied
The primary objective of this study is to evaluate parental satisfaction with communication after their childs laparoscopic surgery by averaging the satisfaction scores from the initial post-laparoscopy questionnaire and the follow-up telephone interview scored from 0 to 100
For secondary objectives responses to open-ended questions during the telephone interview will be qualitatively analyzed to gain insights into specific aspects of the parental experience with laparoscopy The quality of care will be assessed using scores from specific items on the questionnaires related to care quality Additionally the study will analyze the duration of hospitalization to explore any correlation with parental satisfaction The evolution of satisfaction over time will be assessed by comparing initial satisfaction scores with short-term satisfaction scores obtained during the follow-up interview This comparison aims to identify any changes in satisfaction levels particularly concerning the post-discharge period All data will be analyzed using descriptive statistics for frequency and mean scores with further analysis conducted using the software Prism to ensure robustness and validity of the findings
At the end of this study investigators hope to identify areas for improvement in surgical care and communication aiming to enhance the postoperative quality of life for pediatric patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None