AnxietyNCT04687085
Mindful Meditation for Epidural Catheter Placement
A study testing 10 minute mindful meditation recording in people with Anxiety and Pain, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Given the high prevalence of neuraxial analgesia use during labor and the anxiety associated with these procedures, a method to decrease this anxiety could benefit millions of laboring women each year. Mindfulness practice has been used by many groups to decrease anxiety during pregnancy with optimistic results. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- What is being tested?
- 10 minute mindful meditation recording
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2020to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients are eligible for enrollment if they are greater than 18 years of age, admitted for vaginal delivery, anticipating epidural analgesia, and report a numerical pain scale rating of 3 or less at the time of enrollment.
Who cannot join
- Do not speak English or admitted for cesarean delivery will be excluded from the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Effects of a Brief Mindful Meditation Intervention on Patient Anxiety and Satisfaction for Labor Epidural Catheter Placement: a Randomized Controlled Trial
Given the high prevalence of neuraxial analgesia use during labor and the anxiety associated with these procedures, a method to decrease this anxiety could benefit millions of laboring women each year. Mindfulness practice has been used by many groups to decrease anxiety during pregnancy with optimistic results. However, there has been no major study evaluating the role of mindfulness interventions on anxiety associated with neuraxial placement. The purpose of our study is to address this gap in knowledge.
Read the detailed description
The primary objective of this study is to evaluate the effects of a brief mindful meditation intervention on anxiety and satisfaction regarding epidural catheter placement for laboring parturients.The investigators hypothesize that a brief mindful meditation intervention, consisting of a 10 minute auditory instructional practice, implemented before epidural catheter placement will:
- Decrease anxiety
- Increase satisfaction compared to a neutral 10 minute auditory recording control, in participants undergoing labor epidural catheter placement.
The secondary objective of this study is to evaluate whether anesthesia providers experience a difference in satisfaction with labor epidural catheter placement in participants who listen to a brief mindful meditation intervention prior to epidural catheter placement. The investigators hypothesize that anesthesia providers placing labor epidural catheters in patients who listen to a brief mindful meditation intervention prior to labor epidural catheter placement will:
- Experience an increase in satisfaction with labor epidural catheter placement.
- Being tested
- 10 minute mindful meditation recording
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 minute mindful meditation recordingOther
10 minute mindful meditation recording
| Study group | Role | What they receive |
|---|---|---|
| Neutral Content | Placebo comparator | Participants will listen to a 10 minute neutral content recording just prior to epidural catheter placement. Receives: Other: 10 minute mindful meditation recording |
| Mindful Meditation | Experimental | Participants will listen to a 10 minute mindful meditation recording just prior to epidural catheter placement. Receives: Other: 10 minute mindful meditation recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety level after epidural catheter placement
Level of anxiety on a numerical rating scale
Measured: Measure 1 time, 10 minutes after epidural catheter placement
Pain level after epidural catheter placement
Level of pain on a numerical rating scale
Measured: Measure 1 time, 10 minutes after epidural catheter placement
Secondary outcomes (1)
Provider satisfaction level after epidural catheter placement
Anesthesia provider placing the epidural catheter satisfaction with placement conditions on a numerical rating scale
Measured: Measure 1 time, 10 minutes after epidural catheter placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start21 Dec 2020
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dominique Arce, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687085
- Sponsor's protocol ID
- 2019P003456
- Status last verified
- Mar 2022
- First submitted
- 21 Dec 2020
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To maintain privacy and confidentiality, patient data will be labeled with an alphanumeric code, the key to the code will be kept in a secure location separate from other data forms and will only be accessible to the investigators.
Publications
Lumbreras-Marquez MI, Lazaridou A, Villela-Franyutti D, Fields KG, Farber MK, Nelson ER, Schreiber KL, Arce DY. Mindful meditation for epidural catheter placement during labor: a single-center randomized controlled trial. Pain Med. 2026 Jan 1;27(1):26-32. doi: 10.1093/pm/pnaf075.
PubMed 40570097
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Brief Mindful Meditation Intervention on Patient Anxiety and Satisfaction for Labor Epidural Catheter Placement: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04687085
- Acronym / sponsor ID
- 2019P003456
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 29 Dec 2020 (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.
Given the high prevalence of neuraxial analgesia use during labor and the anxiety associated with these procedures, a method to decrease this anxiety could benefit millions of laboring women each year. Mindfulness practice has been used by many groups to decrease anxiety during pregnancy with optimistic results. However, there has been no major study evaluating the role of mindfulness interventions on anxiety associated with neuraxial placement. The purpose of our study is to address this gap in knowledge.
Detailed description
The primary objective of this study is to evaluate the effects of a brief mindful meditation intervention on anxiety and satisfaction regarding epidural catheter placement for laboring parturients.The investigators hypothesize that a brief mindful meditation intervention, consisting of a 10 minute auditory instructional practice, implemented before epidural catheter placement will:
- Decrease anxiety
- Increase satisfaction compared to a neutral 10 minute auditory recording control, in participants undergoing labor epidural catheter placement.
The secondary objective of this study is to evaluate whether anesthesia providers experience a difference in satisfaction with labor epidural catheter placement in participants who listen to a brief mindful meditation intervention prior to epidural catheter placement. The investigators hypothesize that anesthesia providers placing labor epidural catheters in patients who listen to a brief mindful meditation intervention prior to labor epidural catheter placement will:
- Experience an increase in satisfaction with labor epidural catheter placement.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neutral Content | Placebo comparator | Other: 10 minute mindful meditation recordingParticipants will listen to a 10 minute neutral content recording just prior to epidural catheter placement. |
| Mindful Meditation | Experimental | Other: 10 minute mindful meditation recordingParticipants will listen to a 10 minute mindful meditation recording just prior to epidural catheter placement. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients are eligible for enrollment if they are greater than 18 years of age, admitted for vaginal delivery, anticipating epidural analgesia, and report a numerical pain scale rating of 3 or less at the time of enrollment.
Key exclusion criteria (1 listed)
- Do not speak English or admitted for cesarean delivery will be excluded from the study
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 |
|---|---|---|
| 10 minute mindful meditation recording10 minute mindful meditation recording | Other | Mindful Meditation, Neutral Content |
Primary outcome
Anxiety level after epidural catheter placement
Time frame: Measure 1 time, 10 minutes after epidural catheter placement
Level of anxiety on a numerical rating scale
Pain level after epidural catheter placement
Time frame: Measure 1 time, 10 minutes after epidural catheter placement
Level of pain on a numerical rating scale
1 secondary outcome
Provider satisfaction level after epidural catheter placement
Time frame: Measure 1 time, 10 minutes after epidural catheter placement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Derived from this study: PubMed 40570097Lumbreras-Marquez MI, Lazaridou A, Villela-Franyutti D, Fields KG, Farber MK, Nelson ER, Schreiber KL, Arce DY. Mindful meditation for epidural catheter placement during labor: a single-center randomized controlled trial. Pain Med. 2026 Jan 1;27(1):26-32. doi: 10.1093/pm/pnaf075.
- Individual participant dataSharing planned: No. To maintain privacy and confidentiality, patient data will be labeled with an alphanumeric code, the key to the code will be kept in a secure location separate from other data forms and will only be accessible to the investigators.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10 minute mindful meditation recording in people with Anxiety and Pain, run by Brigham and Women's Hospital 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 Mar 2022. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Anxiety level after epidural catheter placement (time frame: Measure 1 time, 10 minutes after epidural catheter placement). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04687085, which also lists 1 linked publication.
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 4 Mar 2022.