EndometriosisNCT06141720
Feasibility of a Mindfulness Intervention for Endometriosis Surgery
A study testing pain education and mindfulness of pain introduction and intervention in people with Endometriosis and Pain, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis, Pain, Mindfulness
- What is being tested?
- pain education and mindfulness of pain introduction and intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2024to 30 Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 years or older
- diagnosis or probable diagnosis of endometriosis
- candidate for surgical procedure for endometriosis
- English speaking
- have access to wifi and email
Who cannot join
- prior formal mindfulness training
- Unable to consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Endometriosis, Pain, Mindfulness
- Being tested
- pain education, mindfulness of pain introduction and intervention
- Medical subject headings
- Endometriosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pain educationBehavioural
Pain education
mindfulness of pain introduction and interventionBehavioural
Brief mindfulness of pain introduction and intervention
| Study group | Role | What they receive |
|---|---|---|
| Standard of care for endometriosis surgery plus education | Active comparator | Not described Receives: Behavioral: pain education |
| Standard of care for endometriosis surgery plus mindfulness | Experimental | Not described Receives: Behavioral: mindfulness of pain introduction and intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of opioid medication
Morphine milligram equivalent following surgery
Measured: 1 week
Use of opioid medication
Morphine milligram equivalent following surgery
Measured: 3 months
Pain intensity
Numerical Pain Rating Scale 0-10, 10 being highest
Measured: 1 week
Pain intensity
Numerical Pain Rating Scale 0-10, 10 being highest
Measured: 3 months
Secondary outcomes (15)
Sleep quality (sleep duration, awakenings, efficiency)
actigraphy monitoring
Measured: 1 week prior to surgery
Sleep quality (sleep duration, awakenings, efficiency)
actigraphy monitoring
Measured: 1 week following surgery
Sleep report
sleep diary (hours slept, activities during day and night)
Measured: 1 week following surgery
Sleep report
sleep diary (hours slept, activities during day and night)
Measured: 1 week prior to surgery
Emotional functioning
Hospital Anxiety and Depression Scale 0-21, 21 is worst
Measured: baseline
Emotional functioning
Hospital Anxiety and Depression Scale 0-21, 21 is worst
Measured: 1 week
Emotional functioning
Hospital Anxiety and Depression Scale 0-21, 21 is worst
Measured: 3 months
Patient global impression of change
Global Impression of change 1-7, 1 is best
Measured: 3 months
Patient global impression of change
Global Impression of change 1-7, 1 is best
Measured: 1 week
Pain catastrophizing
Pain catastrophizing Scale 0-52, 52 is worst
Measured: baseline
Pain catastrophizing
Pain catastrophizing Scale 0-52, 52 is worst
Measured: 1 week
Pain catastrophizing
Pain catastrophizing Scale 0-52, 52 is worst
Measured: 3 months
Treatment satisfaction
Treatment satisfaction 0-10, 10 being best
Measured: 1 week
Treatment satisfaction
Treatment satisfaction 0-10, 10 being best
Measured: 3 months
Heart rate variability
brief HRV assessment baseline and during intervention
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start30 May 2024
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christa Coleman, Milton S. Hershey Medical Center
- Investigators
- Christa Coleman, Principal investigator, Penn State Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141720
- Sponsor's protocol ID
- 23397
- Status last verified
- Oct 2026
- First submitted
- 15 Nov 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No