To establish the effect of a smartphone application for direct patient feedback on patient reported postoperative pain outcomes and pharmaco-therapy in clinical patients.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
(chronic) post-operative pain
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patient reported time in severe pain per separate clinical admission day (8
a.m.-8 a.m.), as reported by APS-POQ-R.
Secondary outcome
During clinical admission measured as reported by APS-POQ-R.
-Patient reported least pain and worst pain level over past 24 hours.
-Number of patient self-reported pain scores per 24 hours.
-Patient reported impact of pain on activity and sleep.
-Patient reported wish for more treatment.
-Patient reported abilities to participate in pain treatment decisions.
-Patient reported adverse effects (nausea, tiredness, dizziness,
itching).
-Patient reported anxiety and helplessness.
-Patient reported satisfaction on pain treatment result.
-Numbers and dose of analgesics administered over a period of 24 hours,
starting after discharge from post anesthetic care unit (PACU).
-Median patient reported least and worst pain score in the intervention
and control group for each separate hospital admission day, this will
be determined for day time (08 a.m.-10 p.m.) and night time (10 p.m. -
8 a.m.) separately.
-All nurse documented pain-scores in the electronic health record.
After hospital discharge measured as reported by BPI-sf.
-Median patient reported pain score over the past 24 hours (NRS 0-10)
prior to the moment of measurement.
-Patient reported least pain, worst pain and current pain (NRS 0-10)
-Any pain treatment (including pharmacological) received and percentage
of pain relief.
-Functional impact of pain (NRS 0-10), social impact of pain (NRS 0-10)
and emotional impact of pain (NRS 0-10).
Background 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. 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 objective
To establish the effect of a smartphone application for direct patient feedback
on patient reported postoperative pain outcomes and pharmaco-therapy in
clinical patients.
Study design
A single center, prospective, randomized, single-blinded, controlled trial.
Intervention
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 this is not the case. After discharge,
patients will report pain scores every two weeks for three months.
Study burden and risks
During the study, apart from the interventions mentioned earlier, all
participants will receive care as usual. These include regular pain checks
during standard nursing rounds multiple times a day, and the use of the bed
bell to contact a nurse if a patient wants to discuss about perceived pain. The
pharmacological post-operative pain therapy will be fully performed in
accordance with the current guidelines that apply to the participating
departments.
We see no additional risks for study participants.
Direct patient feedback may lead to earlier recognition and treatment of
postoperative pain, this can be a benefit for participants of the intervention
group.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- 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 (abdominal oncology, gyneacology,
urology).
- 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
Exclusion criteria
-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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL78324.042.21 |
| Other | NL9697 |
| OMON | NL-OMON20330 |