Penn State Health
Hershey, Pennsylvania, 17033, United States
Location status: Recruiting
NCT Number: NCT06141720
Endometriosis is a common cause of pelvic pain in women which has been historically under-studied and under-diagnosed. The goal of this research is to pilot-test the feasibility and acceptability of a manualized, single-session brief mindfulness-based intervention (BMBI) among participants with endometriosis-related chronic pelvic pain (ECPP) who undergo surgical treatment, and gather preliminary data necessary for future studies assessing BMBI's impact on outcomes in surgically-treated ECPP. This pilot study will enroll 10-20 adult participants with ECPP to receive either a BMBI adjunctive to treatment as usual (TAU; n=5-10) or education with TAU (n=5-10) prior to their ECPP surgery. The central hypothesis is the BMBI is feasible to deliver pre-operatively, acceptable to patients, and may help improve acute post-surgical outcomes through more adaptive stress coping and pain processing, enabled by mindfulness training.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Hershey, Pennsylvania, 17033, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pain education
Brief mindfulness of pain introduction and intervention
Time frame: 1 week
Morphine milligram equivalent following surgery
Time frame: 3 months
Morphine milligram equivalent following surgery
Time frame: 1 week
Numerical Pain Rating Scale 0-10, 10 being highest
Time frame: 3 months
Numerical Pain Rating Scale 0-10, 10 being highest
Time frame: 1 week prior to surgery
actigraphy monitoring
Time frame: 1 week following surgery
actigraphy monitoring
Time frame: 1 week following surgery
sleep diary (hours slept, activities during day and night)
Time frame: 1 week prior to surgery
sleep diary (hours slept, activities during day and night)
Time frame: baseline
Hospital Anxiety and Depression Scale 0-21, 21 is worst
Time frame: 1 week
Hospital Anxiety and Depression Scale 0-21, 21 is worst
Time frame: 3 months
Hospital Anxiety and Depression Scale 0-21, 21 is worst
Time frame: 3 months
Global Impression of change 1-7, 1 is best
Time frame: 1 week
Global Impression of change 1-7, 1 is best
Time frame: baseline
Pain catastrophizing Scale 0-52, 52 is worst
Time frame: 1 week
Pain catastrophizing Scale 0-52, 52 is worst
Time frame: 3 months
Pain catastrophizing Scale 0-52, 52 is worst
Time frame: 1 week
Treatment satisfaction 0-10, 10 being best
Time frame: 3 months
Treatment satisfaction 0-10, 10 being best
Time frame: baseline
brief HRV assessment baseline and during intervention
Time frame: baseline
Pain threshold
Time frame: baseline
Temporal summation of pain
Contact information is provided by the study sponsor or research team.
Milton S. Hershey Medical Center
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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