An observational study in Parent's Satisfaction, Pediatric Surgery and Children Laparoscopic Surgery, sponsored by University Hospital, Brest. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-16.
Sponsored by University Hospital, Brest · Observational
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 child's opinion if possible.
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 child's 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 child's input if possible.Using 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 child's 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.
198 studies on the registry are indexed under Communication; 85 are open to participants now.
This study's enrollment of 10 is below the median of 100 across 27 observational studies indexed under Communication.
Browse Communication studies →University Hospital, Brest is the lead sponsor of 600 studies on the registry; 135 are open to participants now.
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Parents accompanying children undergoing laparoscopic surgery in the paediatric department in Brest.
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Exclusion Criteria:
Parents accompanying children aged 0 to 17 who have undergone laparoscopic surgery in the paediatric surgery department in Brest.
Other: Satisfaction questionnaires
Use of a post-laparoscopy satisfaction questionnaire designed to be adapted to the context of laparoscopic surgery. This post-laparoscopy questionnaire was inspired by the PedsQL generic care satisfaction questionnaire, a standardised and validated questionnaire.
Parent satisfaction score
Mean of the 2 scores on the post-laparoscopy satisfaction questionnaires at inclusion and during the telephone interview (from 0 not at all satisfied to 100 totally satisfied). Using 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)
Time frame: day of inclusion and 7 to 9 days after laparoscopic surgery
Parent satisfaction
Responses to open questions about laparoscopy during the telephone interview
Time frame: 7 to 9 days after laparoscopic surgery
Quality of care
Independent analysis of scores on quality of care items
Time frame: day of inclusion and 7 to 9 days after laparoscopic surgery
Parent satisfaction
Comparison of initial satisfaction (paper post-laparoscopy satisfaction questionnaire at inclusion) with short-term satisfaction (telephone call post-laparoscopy satisfaction questionnaire between the 7th and 9th day after laparoscopic surgery).
Time frame: day of inclusion and 7 to 9 days after laparoscopic surgery
Quality of care
Length of hospital stay
Time frame: about 2 days
Plan to share: Yes — All collected data that underlie results in a publication
Supporting information: Study protocol
Time frame: Data will be available beginning five years and ending fifteen years following the final study report completion.
Access criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
Ran from Jul 2024 to primary completion in Sep 2024, 2 months.
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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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