PainDPFNCT05783440
Direct Patient Feedback on Postoperative Pain
A study testing direct patient feedback in people with Pain, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Postoperative pain is common, can be severe, has a negative impact on outcomes after surgery and brings along major economic costs for society. A substantial part of patients may develop persistent post-surgical pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- direct patient feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Jul 2022to 1 Jan 2025
- Phase
- Interventional
- 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
Who may be able to join
- Participants have to be 18 years or older
- Participants need to undergo a clinical surgical procedure for one of the three medical specialties mentioned above.
- Participants must be admitted to one of the participating surgical wards directly following discharge from the post anesthetic care unit after surgery.
- Participants have to stay admitted to the wards at least till the next day after surgery.
- Participants have to be in the possession of a smartphone that is able to receive a SMS text message and can sent data to a web based server.
- Participants must master the Dutch language and provide their written informed consent on forehand.
- Participants answered the first questionnaire (APS-POQ-R part I) before surgery.
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Patients who do not wish to participate.
- Patients that for physical or cognitive impairments are unable to participate.
- Patients who do not possess a smartphone.
- Patients who are transferred to another ward during hospital admission e.g. the intensive care unit the first night after surgery.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9713EZ
rob spanjersberg, r.spanjersberg@umcg.nl
About this study
Official title: Smartphone Reported Direct Patient Feedback on Postoperative Pain That is Directly Passed on to Surgical Ward Nurses, Effects on Patient Reported Postoperative Pain Outcomes and Pharmaco-therapy. A Prospective, Randomized, Single-blinded, Controlled Tria
Postoperative pain is common, can be severe, has a negative impact on outcomes after surgery and brings along major economic costs for society. A substantial part of patients may develop persistent post-surgical pain. Severity and duration of pain after surgery appear to have a role in this process but the transition from acute postoperative pain to chronic pain is only partially understood.
Effective treatment of postoperative pain is hampered by several barriers, including the way measurement of pain and registration of pain-scores are carried out by nurses in clinical practice. Modern technology offers new opportunities for pain measurement and direct patient feedback on postoperative pain, during and also after clinical admission. We developed a smartphone application that allows clinical patients to report pain scores and other pain related outcomes on postoperative pain with their own telephone device. Patient reported pain scores > 3 on a Numeric Rating Scale (NRS) 0-10 are immediately passed on to the nurse who receives a message of the reported pain score. This can lead to earlier detection of pain and a more timely treatment resulting in improved patient reported outcomes on postoperative pain
Read the detailed description
Postoperative pain is common, can be severe, has a negative impact on outcomes after surgery and brings along major economic costs for society. A substantial part of patients may develop persistent post-surgical pain. Severity and duration of pain after surgery appear to have a role in this process but the transition from acute postoperative pain to chronic pain is only partially understood.
Effective treatment of postoperative pain is hampered by several barriers, including the way measurement of pain and registration of pain-scores are carried out by nurses in clinical practice. Modern technology offers new opportunities for pain measurement and direct patient feedback on postoperative pain, during and also after clinical admission. We developed a smartphone application that allows clinical patients to report pain scores and other pain related outcomes on postoperative pain with their own telephone device. Patient reported pain scores > 3 on a Numeric Rating Scale (NRS) 0-10 are immediately passed on to the nurse who receives a message of the reported pain score. This can lead to earlier detection of pain and a more timely treatment resulting in improved patient reported outcomes on postoperative pain
- Conditions
- Pain
- Being tested
- direct patient feedback
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
direct patient feedbackBehavioural
Participants in the intervention group report postoperative pain scores and other pain related outcomes with their own smartphone. Pain scores reported by smartphone > 3 (NRS 0-10) are immediately passed on to the nurse who will receive a notification on a smartphone.
All patient reported pain-scores by smartphone are stored in a database that is not accessible to medical or nursing staff from the nursing ward.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Applying a system in which patients undergoing surgery can report pain scores and other pain-related outcomes with their own smartphone, both during hospitalization and for three months after discharge. During clinical admission patient reported pain scores > 3 (NRS 0-10) in the intervention group are immediately passed on to the nurse who will receive a notification on a smartphone. In the control group the patients' pain scores are not sent to the nurse. After discharge, patients will report pain scores every two weeks for three months. Receives: Behavioral: direct patient feedback |
| control group | No intervention | Participants in the control group report postoperative pain scores and other pain related outcomes with their own smartphone. Their reported pain-scores will not be surpassed to the nurses on the ward. All patient reported pain-scores by smartphone are stored in a database that is not accessible to medical or nursing staff from the nursing ward. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported time in severe pain
Patient reported time in severe pain per separate clinical admission day (8 a.m.-8 a.m.), as reported by APS-POQ-R.
Measured: every clinical admission day (8 a.m.-8 a.m.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start6 Jul 2022
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- marjolein haveman, Study chair, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783440
- Sponsor's protocol ID
- NL9697
- Acronym
- DPF
- Status last verified
- Mar 2023
- First submitted
- 13 Mar 2023
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Reported Direct Patient Feedback on Postoperative Pain That is Directly Passed on to Surgical Ward Nurses, Effects on Patient Reported Postoperative Pain Outcomes and Pharmaco-therapy. A Prospective, Randomized, Single-blinded, Controlled Tria
- ClinicalTrials.gov ID
- NCT05783440
- Acronym / sponsor ID
- DPF / NL9697
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 24 Mar 2023 (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.
Postoperative pain is common, can be severe, has a negative impact on outcomes after surgery and brings along major economic costs for society. A substantial part of patients may develop persistent post-surgical pain. Severity and duration of pain after surgery appear to have a role in this process but the transition from acute postoperative pain to chronic pain is only partially understood.
Effective treatment of postoperative pain is hampered by several barriers, including the way measurement of pain and registration of pain-scores are carried out by nurses in clinical practice. Modern technology offers new opportunities for pain measurement and direct patient feedback on postoperative pain, during and also after clinical admission. We developed a smartphone application that allows clinical patients to report pain scores and other pain related outcomes on postoperative pain with their own telephone device. Patient reported pain scores > 3 on a Numeric Rating Scale (NRS) 0-10 are immediately passed on to the nurse who receives a message of the reported pain score. This can lead to earlier detection of pain and a more timely treatment resulting in improved patient reported outcomes on postoperative pain
Detailed description
Postoperative pain is common, can be severe, has a negative impact on outcomes after surgery and brings along major economic costs for society. A substantial part of patients may develop persistent post-surgical pain. Severity and duration of pain after surgery appear to have a role in this process but the transition from acute postoperative pain to chronic pain is only partially understood.
Effective treatment of postoperative pain is hampered by several barriers, including the way measurement of pain and registration of pain-scores are carried out by nurses in clinical practice. Modern technology offers new opportunities for pain measurement and direct patient feedback on postoperative pain, during and also after clinical admission. We developed a smartphone application that allows clinical patients to report pain scores and other pain related outcomes on postoperative pain with their own telephone device. Patient reported pain scores > 3 on a Numeric Rating Scale (NRS) 0-10 are immediately passed on to the nurse who receives a message of the reported pain score. This can lead to earlier detection of pain and a more timely treatment resulting in improved patient reported outcomes on postoperative pain
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: direct patient feedbackApplying a system in which patients undergoing surgery can report pain scores and other pain-related outcomes with their own smartphone, both during hospitalization and for three months after discharge. During clinical admission patient reported pain scores > 3 (NRS 0-10) in the intervention group are immediately passed on to the nurse who will receive a notification on a smartphone. In the control group the patients' pain scores are not sent to the nurse. After discharge, patients will report pain scores every two weeks for three months. |
| control group | No intervention | –Participants in the control group report postoperative pain scores and other pain related outcomes with their own smartphone. Their reported pain-scores will not be surpassed to the nurses on the ward. All patient reported pain-scores by smartphone are stored in a database that is not accessible to medical or nursing staff from the nursing ward. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants have to be 18 years or older
- Participants need to undergo a clinical surgical procedure for one of the three medical specialties mentioned above.
- Participants must be admitted to one of the participating surgical wards directly following discharge from the post anesthetic care unit after surgery.
- Participants have to stay admitted to the wards at least till the next day after surgery.
- Participants have to be in the possession of a smartphone that is able to receive a SMS text message and can sent data to a web based server.
Key exclusion criteria (5 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Patients who do not wish to participate.
- Patients that for physical or cognitive impairments are unable to participate.
- Patients who do not possess a smartphone.
- Patients who are transferred to another ward during hospital admission e.g. the intensive care unit the first night after surgery.
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 |
|---|---|---|
| direct patient feedbackParticipants in the intervention group report postoperative pain scores and other pain related outcomes with their own smartphone. Pain scores reported by smartphone > 3 (NRS 0-10) are immediately passed on to the nurse who will receive a notification on a smartphone. All patient reported pain-scores by smartphone are stored in a database that is not accessible to medical or nursing staff from the nursing ward. | Behavioural | Intervention group |
Primary outcome
Patient reported time in severe pain
Time frame: every clinical admission day (8 a.m.-8 a.m.)
Patient reported time in severe pain per separate clinical admission day (8 a.m.-8 a.m.), as reported by APS-POQ-R.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: No
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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.
marjolein haveman study chair
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing direct patient feedback in people with Pain, run by University Medical Center Groningen at 1 site in Netherlands.
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 7 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: status not confirmed, as of the sponsor's last update on 24 Mar 2023. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact marjolein haveman, dr (0503616161, m.e.haveman@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported time in severe pain (time frame: every clinical admission day (8 a.m.-8 a.m.)). 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 24 Mar 2023.