Direct Patient Feedback on Postoperative Pain

Pain Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05783440
• Other study ID #: NL9697
• Status: Recruiting
• Phase: N/A
• Start date: July 6, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: March 2023
• Source: University Medical Center Groningen
• Contact: marjolein haveman, dr
• Phone: 0503616161
• Email: m.e.haveman[@]umcg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain
• Pain, Postoperative

Intervention

Behavioral:
• direct patient feedback
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.

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	every clinical admission day (8 a.m.-8 a.m.)