PainQuReMoNCT05244772
Quality of Recovery After Day Care Surgery With App Controlled Remote Monitoring: a Randomized Controlled Trial
A study testing Remote monitoring in people with Pain and Nausea, run by Onze Lieve Vrouwe Gasthuis at 3 sites in Netherlands.
Trial summary
Non blinded randomized controlled trial with mixed methods design. To assess the experienced quality of recovery after day care surgery between patients provided with remote home monitoring and patients receiving standard discharge care Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Remote monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 3 sitesNetherlands
- Study dates
- 1 Mar 2022to 9 Dec 2022
- Phase
- Interventional
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
Who may be able to join
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Age: older than or equal to 18 years
- Pre-anaesthesia conclusion: ASA I to III
- Scheduled for day care surgery for one of the following surgical specialties:
- gynaecology, eye-nose and throat, oral and maxillofacial, orthopaedics, general and vascular, trauma and urology -In possession of a smartphone
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Not able to speak or understand the Dutch language
- Mentally impaired (e.g. dementia, retardation)
- During study:
- -Patients who experience a unexpected post-operative complication or prolonged recovery with the result that discharge on the same day of the surgical intervention is not possible will be excluded
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
OLVG Hospital
Amsterdam, North Holland, 1091AC
CWZ Hospital
Nijmegen, Limburg, 6532 SZ
Maasstad Hospital
Rotterdam, South Holland, 3079 DZ
About this study
Non blinded randomized controlled trial with mixed methods design. To assess the experienced quality of recovery after day care surgery between patients provided with remote home monitoring and patients receiving standard discharge care
Read the detailed description
Rationale: To date the majority of surgical interventions is performed in day care and patients are being discharged soon after the first critical postoperative period. At home, patients have limited options to contact the hospital in case of severe pain and nausea. We have provided day care surgical patients with a smartphone application for remote monitoring that is configured to self-record postoperative pain and nausea after being discharged from hospital. Furthermore, it provides a messaging service to contact the hospital in case of (severe) pain or nausea. Despite the promising initial patient experiences of such an application, we do not know whether remote monitoring with a smartphone application improves the patient's experience during the recovery period.
Objective: To evaluate the experienced quality of recovery after day care surgery between patients provided with a smartphone application for remote monitoring and patients receiving standard of care (no remote monitoring).
Study design: (Non-blinded) randomized controlled trial with mixed methods design Study population: Adult patients (aged 18 years or older) scheduled for day care surgery Intervention (if applicable): The intervention group receives the smartphone application for remote monitoring during weekdays from 8 am to 17 pm up to 7 days after surgery. With this application, patients are able to record experienced pain and nausea. In addition, they can send messages to the hospital. Daily monitoring is performed by an anaesthesia professional who will contact the patient in case severe pain or nausea is reported in the app. The control group receives standard of care (with post-discharge verbal and paper instructions).
Main study parameters/endpoints: The main study endpoint is the difference between patients using remote monitoring and patients not using remote monitoring in perceived quality of recovery measured with the QoR-15 questionnaire on the 7th day after day care surgery. Secondary endpoints are 1) the overall score on the Quality of Recovery-15 at day 1, 4 and 7 post discharge, 2) the perceived quality of hospital aftercare and 3) experienced psychological effects of remote monitoring during postoperative recovery from day care surgery.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participating in this study does not pose any additional risks either for patients allocated to the intervention group with remote monitoring or for patients allocated tothe standard of care group. Patients in the remote monitoring group are being asked to use a smartphone application to record pain and nausea daily for up to 7 days post discharge. Recording pain and nausea will take 2 minutes daily. Patients from both groups are being asked to fill in the validated QoR-15 questionnaire one day before admission and on the 1st, 4th and 7th day post discharge and this will take 2.5 minutes. No extra hospital visits, physical examinations or tests are required. Patients in the remote monitoring group could benefit from participating in the study because they are monitored daily by a healthcare professional. Therefore, severe pain, nausea and possibly other complications can be noticed and managed earlier.
- Being tested
- Remote monitoring
- Keywords
- eHealth, Remote monitoring, Anaesthesia, Day care surgery
- Medical subject headings
- Pain, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote monitoringOther
Remote monitoring with a smartphone application of pain and nausea after day care surgery
| Study group | Role | What they receive |
|---|---|---|
| Remote monitoring | Experimental | At discharge, patients in the remote monitoring group receive verbal and paper care- and recovery instructions from a day care ward nurse and in adittion they will have a monitoring application installed on theirpersonal smartphone. Once they are back home, they can start recording pain and nausea and ask questions about their recovery with the application and report back the anaesthesia backoffice. Receives: Other: Remote monitoring |
| Standard care | No intervention | At discharge, patients in the standard care group receive verbal and paper care- and recovery instructions from a day care ward nurse. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery
To assess the difference between patients using remote monitoring and patients not using remote monitoring in perceived quality of recovery measured with the QoR-15 questionnaire on the 7th day after day care surgey
Measured: 7th day after day care surgery
Secondary outcomes (7)
Postoperative pain
To assess the experienced postoperative pain (POP) between patients provided with a smartphone application for remote monitoring and patients receiving standard of care (no remote monitoring) after day care surgery.
Measured: 1st, 4th and 7th day after day care surgery
Post discharge nausea and vomiting
To assess the experienced post discharge nausea and vomiting (PDNV) between patients provided with a smartphone application for remote monitoring and patients receiving standard of care (no remote monitoring) after day care surgery.
Measured: 1st, 4th and 7th day after day care surgey
Surgical complications
To assess the difference in the number of surgical complications rated with the Clavien Dindo classification of surgical complication between patients provided with a smartphone application for remote monitoring and patients receiving standard of care (no remote monitoring) after day care surgery.
Measured: 1st 4th and 7th day after day care surgey
Re-admissions
To assess the difference in the number of re-admissions between patients provided with a smartphone application for remote monitoring and patients receiving standard of care (no remote monitoring) after day care surgery.
Measured: 1st, 4th and 7th day after day care surgery
Contact with healthcare professionals
To assess the difference in the number of hospital contacts / general practitioner between patients provided with a smartphone application for remote monitoring and patients receiving standard of care (no remote monitoring) after day care surgery.
Measured: 1st, 4th and 7th day after day care surgey
Experienced communication
To assess the difference in experienced quality of communication with the hospital staff between patients provided with a smartphone application for remote monitoring and patients receiving standard of care (no remote monitoring) after day care surgery.
Measured: 1st, 4th and 7th day after day care surgey
Experienced psychological effects
- assess the experienced psychological effects remote monitoring in patients recovering from day care surgery.
Measured: 1st, 4th and 7th day after day care surgey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start1 Mar 2022
- Primary completion9 Dec 2022
- Study completion9 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Onze Lieve Vrouwe Gasthuis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M.B. Godfried, Onze Lieve Vrouwe Gasthuis
- Investigators
- Marc Godfried, PhD, Principal investigator, OLVG HospitalSeppe Koopman, PhD, Principal investigator, Maasstad HospitalRobert v Dongen, PhD, Principal investigator, CWZ Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244772
- Sponsor's protocol ID
- NL78144.100.21 / WO21.083
- Acronym
- QuReMo
- Status last verified
- Oct 2026
- First submitted
- 9 Feb 2022
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study will be registered before inclusion of the first patient on www.clinicaltrials.gov. The results of the study will find their way into (inter-) national scientific journals and guidelines. We will submit analyses to scientific journals in the field of anaesthesiology.
Publications
Thiel B, Godfried M, van Emst M, Vernooij L, van Vliet L, Rumke E, Snoeck M, Koopman S, Kalkman C. Discharge with a smartphone application for follow-up after day care surgery: a randomised controlled trial. BJA Open. 2025 Sep 25;16:100489. doi: 10.1016/j.bjao.2025.100489. eCollection 2025 Dec.
PubMed 41079519Thiel B, Godfried MB, van Emst ME, Vernooij LM, van Vliet LM, Rumke E, van Dongen RTM, Gerrits W, Koopman JSHA, Kalkman CJ. Quality of recovery after day care surgery with app-controlled remote monitoring: study protocol for a randomized controlled trial. Trials. 2023 Feb 9;24(1):102. doi: 10.1186/s13063-023-07121-6.
PubMed 36759858