REmotely-delivered Supportive Programs for Improving Surgical Pain and disTrEss

Anxiety Clinical Trial

Official title: REmotely-delivered Supportive Programs for Improving Surgical Pain Dnd disTrEss (RESPITE)

Status Recruiting

Clinical Trial Summary

The purpose of this research study is to learn how two different supportive programs may help women feel better after surgery. This study will measure if one type of supportive program is more useful than the other for improving wellbeing after surgery.

Clinical Trial Description

Primary Objective: To determine efficacy of eHealth Mindful Movement and Breathing (eMMB) as compared to Life Impact Reflection (LIR) for improving postoperative pain intensity 4-weeks postoperative in patients who received abdominal surgery for a suspected gynecologic malignancy.

Secondary Objectives:

• At week 2 and 3 months post-operative, to determine efficacy of eHealth Mindful Movement and Breathing as compared to LIR for improving pain intensity in patients who received abdominal surgery for a suspected gynecologic malignancy.

• At week 2, week 4, and 3 months postoperative, to determine efficacy of eHealth Mindful Movement and Breathing as compared to LIR for improving affective pain in patients who received abdominal surgery for a suspected gynecologic malignancy.

• To determine efficacy of eHealth Mindful Movement and Breathing as compared to LIR for improving post-operative acute pain (pain intensity within 1 week post-surgery) in patients who received abdominal surgery for a suspected gynecologic malignancy.

• At week 2, week 4, and 3 months postoperative, to determine efficacy of eHealth Mindful Movement and Breathing as compared to LIR for improving pain interference in patients who received abdominal surgery for a suspected gynecologic malignancy.

• At week 2, week 4, and 3 months postoperative, to determine efficacy of eHealth Mindful Movement and Breathing as compared to LIR for improving psychological distress symptoms (i.e., depression) in patients who received abdominal surgery for a suspected gynecologic malignancy.

• At week 2, week 4, and 3 months postoperative, to determine efficacy of eHealth Mindful Movement and Breathing as compared to LIR for improving psychological distress symptoms (i.e., anxiety) in patients who received abdominal surgery for a suspected gynecologic malignancy.

• At week 2, week 4, and 3 months postoperative, to determine efficacy of eHealth Mindful Movement and Breathing as compared to LIR for improving sleep disturbances in patients who received abdominal surgery for a suspected gynecologic malignancy. ;

Related Conditions & MeSH terms

• Anxiety
• Genital Neoplasms, Female
• Malignant Female Reproductive System Neoplasm
• Pain, Postoperative
• Postoperative Depression
• Sleep Disturbance

• NCT number: NCT05625360
• Study type: Interventional
• Source: Wake Forest University Health Sciences
• Contact: Study Coordinator
• Phone: 336-713-0677
• Email: radellin@wakehealth.edu
• Status: Recruiting
• Phase: Phase 3
• Start date: June 13, 2023
• Completion date: August 31, 2026