Clinical trial NCT06447298: Evaluation of the Satisfaction of Parents Accompanying Children Who Have Undergone Laparoscopic Surgery
Official title: Evaluation of the Satisfaction of Parents Accompanying Children Who Have Undergone Laparoscopic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parent's Satisfaction
Pediatric Surgery
Children Laparoscopic Surgery
Coelioscopy
Communication
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Parents accompanying children undergoing laparoscopic surgery in the paediatric department in Brest.

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 child's 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 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.

Eligibility criteria: Inclusion Criteria:

* Accompanying parents of children from 0 to 17 years of age
* Accompanying parents of children treated by one of the following laparoscopic procedures: laparoscopy and thoracoscopy, laparoscopies requiring a mini-laparotomy for extraction of the part, and laparoscopies carried out on an outpatient basis.
* No objection from the parent accompanying the child

Exclusion Criteria:

* Parents who are minors
* Parents under legal protection (guardianship, curatorship) or deprived of liberty
* Need for intraoperative conversion.
* Insufficient knowledge of the French language to complete the post-laparoscopy satisfaction questionnaire.
* Not affiliated to the social security system.

Primary outcomes:
measure: Parent satisfaction score
timeFrame: day of inclusion and 7 to 9 days after laparoscopic surgery
Secondary outcomes:
measure: Parent satisfaction
timeFrame: 7 to 9 days after laparoscopic surgery
measure: Quality of care
timeFrame: day of inclusion and 7 to 9 days after laparoscopic surgery
measure: Parent satisfaction
timeFrame: day of inclusion and 7 to 9 days after laparoscopic surgery
measure: Quality of care
timeFrame: about 2 days
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU Brest
Study officials:
References: