Mindful Meditation for Epidural Catheter Placement

• ClinicalTrials.gov Identifier: NCT04687085
• Recruitment Status: Completed
• First Posted: December 29, 2020
• Last Update Posted: March 4, 2022
• Sponsor: Brigham and Women's Hospital
• Information provided by (Responsible Party): Dominique Arce, Brigham and Women's Hospital

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment	Phase
Anxiety; Pain	Other: 10 minute mindful meditation recording	Not Applicable

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:

1. Decrease anxiety
2. 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:

1. Experience an increase in satisfaction with labor epidural catheter placement.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effects of a Brief Mindful Meditation Intervention on Patient Anxiety and Satisfaction for Labor Epidural Catheter Placement: a Randomized Controlled Trial
• Actual Study Start Date: December 21, 2020
• Actual Primary Completion Date: November 30, 2021
• Actual Study Completion Date: November 30, 2021

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Neutral Content; Participants will listen to a 10 minute neutral content recording just prior to epidural catheter placement.	Other: 10 minute mindful meditation recording; 10 minute mindful meditation recording
Experimental: Mindful Meditation; Participants will listen to a 10 minute mindful meditation recording just prior to epidural catheter placement.	Other: 10 minute mindful meditation recording; 10 minute mindful meditation recording

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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

Secondary Outcome Measures :

1. Provider satisfaction level after epidural catheter placement [ Time Frame: Measure 1 time, 10 minutes after epidural catheter placement ]
   Anesthesia provider placing the epidural catheter satisfaction with placement conditions on a numerical rating scale

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: pregnancy
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Do not speak English or admitted for cesarean delivery will be excluded from the study

Contacts and Locations

Locations

United States, Massachusetts

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Brigham and Women's Hospital

More Information

• Responsible Party: Dominique Arce, Instructor in Anesthesia, Harvard Medical School, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT04687085
• Other Study ID Numbers: 2019P003456
• First Posted: December 29, 2020
• Last Update Posted: March 4, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Anxiety Disorders; Mental Disorders