Parent's SatisfactionCOELIOCOMNCT06447298
Evaluation of the Satisfaction of Parents Accompanying Children Who Have Undergone Laparoscopic Surgery
An observational study of Parent's Satisfaction and Pediatric Surgery, run by University Hospital, Brest at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parent's Satisfaction, Pediatric Surgery, Children Laparoscopic Surgery
- What is being tested?
- Satisfaction questionnaires
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jul 2024to 23 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parents accompanying children undergoing laparoscopic surgery in the paediatric department in Brest.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Parent's Satisfaction, Pediatric Surgery, Children Laparoscopic Surgery, Coelioscopy, Communication
- Being tested
- Satisfaction questionnaires
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Satisfaction questionnairesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Parents accompanying children | Parents accompanying children aged 0 to 17 who have undergone laparoscopic surgery in the paediatric surgery department in Brest. Receives: Other: Satisfaction questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: day of inclusion and 7 to 9 days after laparoscopic surgery
Secondary outcomes (4)
Parent satisfaction
Responses to open questions about laparoscopy during the telephone interview
Measured: 7 to 9 days after laparoscopic surgery
Quality of care
Independent analysis of scores on quality of care items
Measured: 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).
Measured: day of inclusion and 7 to 9 days after laparoscopic surgery
Quality of care
Length of hospital stay
Measured: about 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start22 Jul 2024
- Primary completion23 Sep 2024
- Study completion23 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parent's SatisfactionStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447298
- Sponsor's protocol ID
- 29BRC24.0129
- Acronym
- COELIOCOM
- Status last verified
- Oct 2024
- First submitted
- 3 Jun 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Satisfaction of Parents Accompanying Children Who Have Undergone Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT06447298
- Acronym / sponsor ID
- COELIOCOM / 29BRC24.0129
- Conditions
- Parent's Satisfaction, Pediatric Surgery, Children Laparoscopic Surgery, Coelioscopy, Communication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 23 Sep 2024 (actual)
- Study completion
- 23 Sep 2024 (actual)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parents accompanying children | – | Other: Satisfaction questionnairesParents accompanying children aged 0 to 17 who have undergone laparoscopic surgery in the paediatric surgery department in Brest. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parents accompanying children undergoing laparoscopic surgery in the paediatric department in Brest.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Satisfaction questionnairesUse 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. | Other | Parents accompanying children |
Primary outcome
Parent satisfaction score
Time frame: day of inclusion and 7 to 9 days after laparoscopic surgery
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)
4 secondary outcomes
Parent satisfaction
Time frame: 7 to 9 days after laparoscopic surgery
Quality of care
Time frame: day of inclusion and 7 to 9 days after laparoscopic surgery
Parent satisfaction
Time frame: day of inclusion and 7 to 9 days after laparoscopic surgery
Quality of care
Time frame: about 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parent's Satisfaction and Pediatric Surgery, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent satisfaction score (time frame: day of inclusion and 7 to 9 days after laparoscopic surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.