Evaluation of the Satisfaction of Parents Accompanying Children Who Have Undergone Laparoscopic Surgery

Communication Clinical Trial

— COELIOCOM  

Official title:

Evaluation of the Satisfaction of Parents Accompanying Children Who Have Undergone Laparoscopic Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06447298
• Other study ID #: 29BRC24.0129
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: June 2024
• Source: University Hospital, Brest
• Contact: Philine DE VRIES, Pr
• Phone: 0298223320
• Email: Philine.devries[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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. They 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.

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 (1), not necessarily linked to clinical outcomes. Enhancing patient satisfaction can also reduce postoperative complications and improve recovery (2).

Using a custom satisfaction questionnaire based on the standardized and validated PedsQL generic care satisfaction questionnaire (3), 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 (4).

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, we hope to identify areas for improvement in surgical care and communication, aiming to enhance the postoperative quality of life for pediatric patients.

References / Citation :

1. Avery KNL et al. Satisfaction with care: an independent outcome measure in surgical oncology. 2006

2. William O.Cooper and al. Use of Unsolicited Patient Observations to Identify Surgeons With Increased Risk for Postoperative Complications. 2017

3. Varni JW, Seid M, Rode CA. The PedsQL™: measurement model for the pediatric quality of life inventory. Med Care 1999. / Varni JW, Seid M, Kurtin PS. PedsQL™ 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. / Varni JW, Seid M, Knight TS, Uzark K & Szer IS. The PedsQL™ 4.0 Generic Core Scales: Sensitivity, responsiveness, and impact on clinical decision-making. Journal of Behavioral Medicine.

4. Lopes J, Oliveira A, Baptista A, Ferreira EO. Factors influencing patient and parents' satisfaction on pediatric dermatologic surgery. International Journal of Dermatology. 2020.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communication
• Pediatric Surgery

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	day of inclusion and 7 to 9 days after laparoscopic surgery
Secondary	Parent satisfaction	Responses to open questions about laparoscopy during the telephone interview	7 to 9 days after laparoscopic surgery
Secondary	Quality of care	Independent analysis of scores on quality of care items	day of inclusion and 7 to 9 days after laparoscopic surgery
Secondary	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).	day of inclusion and 7 to 9 days after laparoscopic surgery
Secondary	Quality of care	Length of hospital stay	about 2 days