Direct Patient Feedback on Postoperative Pain

NCT ID: NCT05783440

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-06
• Study Completion Date: 2025-01-01

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

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Intervention group

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.

Group Type: EXPERIMENTAL

direct patient feedback

Intervention Type: BEHAVIORAL

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.

control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

marjolein haveman

Role: STUDY_CHAIR

UMCG

Locations

University Medical Center Groningen

Groningen, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

marjolein haveman, dr

Role: CONTACT

m.e.haveman@umcg.nl

0503616161

Facility Contacts

rob spanjersberg

Role: primary

r.spanjersberg@umcg.nl

Other Identifiers

NL9697

Identifier Type: -

Identifier Source: org_study_id