- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05433636
Mindful Waiting Room
Idle Waiting or Meditating: Does a Brief, Mindfulness Intervention in the Clinic Waiting Room Improve Patient Outcomes?
This will be a single-site, five-arm, parallel group randomized control trial involving patients seeking integrative healthcare. Four different styles of 5-minute, audio-recoded mindfulness practices delivered in the clinic waiting room will be compared with a 5-minute audio-recording about integrative healthcare.
A secondary sub-analysis will investigate the most effective mindfulness practice style for patients presenting at the clinic with elevated anxiety, depression, or pain.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Adam Hanley
- Phone Number: 8012134191
- Email: adam.hanley@utah.edu
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84112
- Recruiting
- University of Utah
-
Contact:
- Adam W Hanley
- Phone Number: 801-213-4191
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Seeking treatment at the Huntsman Cancer Institute's Wellness Center
- Adults 18+
- Facility with the English language that is adequate to complete study procedures
Exclusion Criteria:
- Cognitive impairment preventing completion of study procedures
- An unstable illness judged by medical staff to interfere with study treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Body Scan Practice
|
Patients will listen to a 5-minute, audio-recorded body scan practice.
|
Experimental: Mindful Breathing Practice
|
Patients will listen to a 5-minute, audio-recorded mindful breathing practice.
|
Experimental: Mindfulness of Discomfort Practice
|
Patients will listen to a 5-minute, audio-recorded mindfulness of discomfort practice.
|
Experimental: Mindful Savoring Practice
|
Patients will listen to a 5-minute, audio-recorded mindful savoring practice.
|
Active Comparator: Integrative Health Recording
|
Patients will listen to a 5-minute, audio-recorded description of integrative health.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability
Time Frame: A single 5-minute period
|
75% of patients that begin an audio recording will listen to the full, 5-minute recording
|
A single 5-minute period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pain
Time Frame: Immediately before to after 5-minute audio recording
|
Single item assessing pain ("Right now, I feel physical pain") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale.
Higher scores indicate greater pain.
|
Immediately before to after 5-minute audio recording
|
Change in Anxiety
Time Frame: Immediately before to after 5-minute audio recording
|
Single item assessing anxiety ("Right now, I feel nervous, anxious or on edge") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale.
Higher scores indicate greater anxiety.
|
Immediately before to after 5-minute audio recording
|
Change in Depression
Time Frame: Immediately before to after 5-minute audio recording
|
Single item assessing depression ("Right now, I feel down, depressed, of uninterested in life") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale.
Higher scores indicate greater depression.
|
Immediately before to after 5-minute audio recording
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00085446_AM_00042941
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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