NCT05346692

Digital Meditation for Postoperative Pain Control After Abdominal Surgery for Cancer

A Prospective, Double-Arm Pilot Study to Investigate the Safety, Feasibility and Acceptability of a Digital Mindfulness Intervention Following Open Abdominal Surgery for Cancer

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial tests a digital meditation for postoperative pain control after abdominal surgery for cancer. Mindfulness interventions such as guided meditation may improve pain control and decrease stress. Including a brief mindfulness intervention administered via test messages as part of postoperative care may improve pain severity, decrease opioid use, and improve patient responses to non-surgical treatments.

Detailed description

PRIMARY OBJECTIVES: I. To investigate and define anticipated and unanticipated adverse events (AEs) related to a daily virtual mindfulness intervention delivered via short message service (SMS) text messaging and to test its safety in the postoperative period amongst patients with cancer. II. To determine the feasibility and acceptability of a novel, brief mindfulness intervention delivered via SMS text messaging in the postoperative period amongst patients undergoing surgery for cancer. III. To determine the feasibility and acceptability of an artificial intelligence platform to deliver and receive SMS text messages for the purpose of delivering pain assessment tools and collecting and storing pain-specific and patient reported outcomes. OUTLINE: Patients are assigned to 1 of 2 arms. ARM I: Patients complete pain survey via text message daily for 10 days after surgery. Patients also complete telephone interview 2 weeks after surgery. ARM II: Patients complete mindfulness intervention via text message daily for 10 days after surgery. Patients also complete telephone interview 2 weeks after surgery.

Conditions

• Hematopoietic and Lymphoid System Neoplasm
• Malignant Solid Neoplasm

Interventions

Type	Name	Description
OTHER	Survey Administration	Complete Survey
OTHER	Interview	Complete Interview
OTHER	Text Message-Based Navigation Intervention	Complete mindfulness intervention
OTHER	Interview	Complete interview

Timeline

• Start date: 2022-03-28
• Primary completion: 2023-07-12
• Completion: 2023-07-12
• First posted: 2022-04-26
• Last updated: 2025-01-14

Locations

1 site across 1 country: United States