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Direct Patient Feedback on Postoperative Pain (DPF)

Primary Purpose

Pain

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
direct patient feedback
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. 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: 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.

Sites / Locations

  • University Medical Center GroningenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 13, 2023
Last Updated
March 13, 2023
Sponsor
University Medical Center Groningen
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1. Study Identification

Unique Protocol Identification Number
NCT05783440
Brief Title
Direct Patient Feedback on Postoperative Pain
Acronym
DPF
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medical Center Groningen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
direct patient feedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient reported time in severe pain
Description
Patient reported time in severe pain per separate clinical admission day (8 a.m.-8 a.m.), as reported by APS-POQ-R.
Time Frame
every clinical admission day (8 a.m.-8 a.m.)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
marjolein haveman, dr
Phone
0503616161
Email
m.e.haveman@umcg.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
marjolein haveman
Organizational Affiliation
umcg
Official's Role
Study Chair
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713EZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
rob spanjersberg
Email
r.spanjersberg@umcg.nl

12. IPD Sharing Statement

Plan to Share IPD
No

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Direct Patient Feedback on Postoperative Pain

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