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Digital Meditation for Postoperative Pain Control After Abdominal Surgery for Cancer

Malignant Solid Neoplasm Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05346692
Study type Interventional
Source Emory University
Contact Maggie Diller, MD
Phone 404-778-3712
Email maggie.l.diller@emory.edu
Status Recruiting
Phase Early Phase 1
Start date March 28, 2022
Completion date October 31, 2025
View Details
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