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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03100669
Other study ID # 17/08/082
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2017
Est. completion date December 31, 2019

Study information

Verified date January 2020
Source University Hospital, Antwerp
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

MIRP (Minimally Invasive Repair of Pectus) as surgical correction of pectus excavatum or carinatum is performed to achieve physiological, cosmetic, and psychological benefits for the patient. Surgery is often associated with severe postoperative pain. In this study the researchers want to registrate pain, sleep, nausea/vomiting, and daily activities in short and long term follow up.


Description:

In order to provide pain patients with an individualized approach to their pain problem after MIRP we developed an electronic medical record coupled to a set of telemetric medical-grade devices. Appi@Home (Antwerp Personalized Pain Initiative) supports an innovative approach to (sub)acute conditions by offering a platform for continuous follow-up. Patients are provided with a toolbox and an app that continuously collects objective outcome data (i.e. pain intensity, sleep quality, physical activity). The integrated system allows the care givers to respond very quickly to changing clinical conditions of the patient, making a very adaptive and individualized follow-up possible for these patients. In addition, the patient becomes an active participant in the global therapeutic approach.

Patients receive the toolbox two week prior to surgery with access to the internet platform for questionnaires fill-in procedure. Up to ten week after surgery pain intensity, sleep quality and physical activity will be monitored subjectively by a scoring table (0-10, 0 no pain-bad sleeping quality-no activity, 10 maximum of pain-excellent sleeping quality- a lot of activity) and objectively by blood pressure device, oxygen saturation monitoring, activity tracker and sleep registration tool.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date December 31, 2019
Est. primary completion date September 30, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- elective pectus repair

- signed informed consent

Exclusion Criteria:

- chronic opioid use (> 3 months)

- history of ongoing psychiatric disease

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Pectus surgery
Patients undergoing surgical repair of pectus excavatum or carinatum

Locations

Country Name City State
Belgium University hospital Antwerp Edegem Antwerp

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Antwerp Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Other Rosenberg self-esteem questionnaire Preoperative evaluation of self-esteem by the Rosenberg self-esteem questionnaire, via a patient specific online platform Allowed period for fill in: from two weeks before planned surgery until day before planned surgery
Other Hospital anxiety and depression scale (HAD) Preoperative evaluation of anxiety and depression by the HAD questionnaire, via a patient specific online platform Allowed period for fill in: from two weeks before planned surgery until day before planned surgery
Other State-Trait anxiety Inventory (STAI) Preoperative evaluation of state and trait characteristics by the STAI questionnaire, via a patient specific online platform Allowed period for fill in: from two weeks before planned surgery until day before planned surgery
Other Multidisciplinary Pain Inventory (MPI) Postoperative evaluation of pain severity and interference by the MPI questionnaire, via a patient specific online platform Allowed period for fill in: first two weeks after hospital discharge
Other Coping Pain Questionnaire (CPQ) Postoperative evaluation of coping strategy (active, passive, self-efficacy) by the CPQ questionnaire, via a patient specific online platform Allowed period for fill in: first two weeks after hospital discharge
Primary Pain pain registration via numeric rating scale during hospitalization up to 10 weeks after surgery 10 weeks after surgery
Secondary Sleep hours of sleep up to 10 weeks after surgery 2 weeks before up to 10 weeks after surgery
Secondary Daily activity daily activity via scale (0: no activity and 10 maximum of activities) and activity tracker device during hospitalization up to 10 weeks after surgery 2 weeks before up to 10 weeks after surgery
Secondary Nausea registration of nausea and vomiting by questionnaire during hospitalization period From day of surgery until hospital discharge (approximately 7 days)
Secondary Mobility Daily mobility assessment by attending physiotherapist via scale (1: exercises in bed, 2: exercises while sitting, 3: exercises while standing, 4: exercises while walking) during hospitalization From day of surgery until hospital discharge (approximately 7 days)
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