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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Mindfulness Intervention for Endometriosis Surgery
- ClinicalTrials.gov ID
- NCT06141720
- Acronym / sponsor ID
- 23397
- Conditions
- Endometriosis, Pain, Mindfulness
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care for endometriosis surgery plus education | Active comparator | Behavioral: pain education |
| Standard of care for endometriosis surgery plus mindfulness | Experimental | Behavioral: mindfulness of pain introduction and intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- prior formal mindfulness training
- Unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pain educationPain education | Behavioural | Standard of care for endometriosis surgery plus education |
| mindfulness of pain introduction and interventionBrief mindfulness of pain introduction and intervention | Behavioural | Standard of care for endometriosis surgery plus mindfulness |
Primary outcome
Use of opioid medication
Time frame: 1 week
Morphine milligram equivalent following surgery
Use of opioid medication
Time frame: 3 months
Morphine milligram equivalent following surgery
Pain intensity
Time frame: 1 week
Numerical Pain Rating Scale 0-10, 10 being highest
Pain intensity
Time frame: 3 months
Numerical Pain Rating Scale 0-10, 10 being highest
15 secondary outcomes
Sleep quality (sleep duration, awakenings, efficiency)
Time frame: 1 week prior to surgery
Sleep quality (sleep duration, awakenings, efficiency)
Time frame: 1 week following surgery
Sleep report
Time frame: 1 week following surgery
Sleep report
Time frame: 1 week prior to surgery
Emotional functioning
Time frame: baseline
Emotional functioning
Time frame: 1 week
Emotional functioning
Time frame: 3 months
Patient global impression of change
Time frame: 3 months
Patient global impression of change
Time frame: 1 week
Pain catastrophizing
Time frame: baseline
Pain catastrophizing
Time frame: 1 week
Pain catastrophizing
Time frame: 3 months
Treatment satisfaction
Time frame: 1 week
Treatment satisfaction
Time frame: 3 months
Heart rate variability
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christa Coleman principal investigator
Penn State Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of opioid medication (time frame: 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.