REmotely-delivered Supportive Programs for Improving Surgical Pain and disTrEss
REmotely-delivered Supportive Programs for Improving Surgical Pain Dnd disTrEss (RESPITE)
Wake Forest University Health Sciences
160 participants
Jun 13, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Participants age 18 years and older at time of consent.
- 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
- Able to understand, read and write English (since the intervention is conducted in English)
Exclusion Criteria3
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Presence of a psychotic disorder, current suicidal ideation, or other unstable major psychiatric condition documented by diagnosis in the medical chart.
- Unwillingness or inability to follow study procedures
Interventions
The self-directed intervention includes an approximately 20-minute eMMB will teach synergistic components: (a) Mindful Meditation - 2 minutes of observing the current state of the body, emotions, thoughts, energy, and breath. Mindful attention may facilitate safe physical movements; (b) Mindful Movement - 10 minutes of gentle movements coordinated with and intended to enhance the breath; (c) Breathing and Relaxation - 3 minutes of placing the hands above the navel (rather than on the belly to avoid discomfort) and noticing them rise and fall with a focus on slightly extending the exhale, which will prepare participants for meditation); (d) Meditation - 5 minutes of observing the natural breath without reacting to it.
This self-directed intervention will focus on active listening, reflection of statements, and avoiding negative judgments. Participants will write brief diary entries daily for four weeks postoperatively and as they choose thereafter. Participants will be given the option of completing diaries on the tablet computer or paper. The instructions for daily diary entries will be, "What were some of the events or circumstances that affected you in the past day? Think back over the past day and write down on the lines below up to five events that had an impact on you." A study team member will call participants to encourage diary completion two days (Postop Day 3) and two weeks after the synchronous session.
Various PROMIS questionnaires will be completed by participants (Pain Interference, Sleep Disturbance, Physical Function, Anxiety and Depression)
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05625360