← Back to Search

Supportive eHealth Programs for Postoperative Pain

Phase 3

Recruiting

Led By Stephanie J Sohl, PhD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled for an abdominal gynecological surgery (i.e., uterine, ovarian) to remove a mass that is suspected to be malignant

Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and 2 weeks, 4 weeks and 3 months postoperatively

Awards & highlights

Study Summary

This trial will compare two types of programs to see which helps women feel better after surgery. #medicalresearch

Who is the study for?

This trial is for women over 18 who are about to have abdominal surgery for suspected malignant masses in the reproductive system. They must be able to perform daily activities with ease (ECOG ≤1), understand English, and consent to participate. Those with severe psychiatric conditions or suicidal thoughts, or who can't follow study procedures cannot join.Check my eligibility

What is being tested?

The study compares two supportive programs delivered remotely: eHealth Mindful Movement and Breathing versus Life Impacts Reflection. It aims to determine which program better improves wellbeing after surgery using PROMIS Questionnaires for assessment.See study design

What are the potential side effects?

Since this trial involves non-invasive supportive programs rather than medication, traditional side effects are not expected. However, participants may experience emotional discomfort when reflecting on life impacts or while practicing mindful movements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for surgery to remove a suspected cancerous mass in my abdomen.

Select...

I am fully active and can carry on all pre-disease activities without restriction.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline and 2 weeks, 4 weeks and 3 months postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline and 2 weeks, 4 weeks and 3 months postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and 2 weeks, 4 weeks and 3 months postoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Pain Intensity Scores - PROMIS Pain Intensity Questionnaire

Secondary outcome measures

Anxiety- Short Form 4a Questionnaire

Change in Affective Pain - PROMIS Questionnaire

Change in Pain Intensity - PROMIS Pain Intensity Questionnaire

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1 - eHealth Mindful Movement and Breathing Group (eMMB)Experimental Treatment2 Interventions

Participants will be given access to 20-minute eMMB videos (either saved as a local files on an iPad or via links to watch on their own devices) with written instructions for eMMB and to watch a video at least once before surgery (videos have the same content, one is taught in a bed and one in a chair). The instructor will call participants before surgery to offer guidance upon request and meet with participants individually via a synchronous videoconference or telephone session, postoperative day 1 (the day after surgery), or as soon as feasible.

Group II: Arm 2 Life Impacts Reflection Group (LIR)Active Control2 Interventions

The format for interactions with an LIR interventionist, frequency of recommended home practice (brief diary entries), and home assessments will be matched to the eMMB group. LIR will not include active ingredients of eMMB.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,694 Total Patients Enrolled

Wake Forest University Health SciencesLead Sponsor

1,242 Previous Clinical Trials

1,004,326 Total Patients Enrolled

4 Trials studying Postoperative Pain

246 Patients Enrolled for Postoperative Pain

Stephanie J Sohl, PhDPrincipal InvestigatorWake Forest Baptist Comprehensive Cancer Center

1 Previous Clinical Trials

15 Total Patients Enrolled

Media Library

Arm 1 - eHealth Mindful Movement and Breathing Group (eMMB) Clinical Trial Eligibility Overview. Trial Name: NCT05625360 — Phase 3

Postoperative Pain Research Study Groups: Arm 1 - eHealth Mindful Movement and Breathing Group (eMMB), Arm 2 Life Impacts Reflection Group (LIR)

Postoperative Pain Clinical Trial 2023: Arm 1 - eHealth Mindful Movement and Breathing Group (eMMB) Highlights & Side Effects. Trial Name: NCT05625360 — Phase 3

Arm 1 - eHealth Mindful Movement and Breathing Group (eMMB) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05625360 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining positions available for participants in this experiment?

"Data hosted on clinicaltrials.gov reveals that this trial has ceased patient recruitment, with the initial post dating back to January 1st 2023 and the most recent update being November 21st 2022. However, 1070 other studies are currently open for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

REmotely-delivered Supportive Programs for Improving Surgical Pain and disTrEss

2023. "REmotely-delivered Supportive Programs for Improving Surgical Pain and disTrEss". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05625360.

All > Sleep Disorder > Genital Warts