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Mindful Waiting Room

Primary Purpose

Anxiety State, Depressive State, Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Body Scan
Mindful Breathing
Mindfulness of Discomfort
Mindful Savoring
Integrative Health Recording
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety State

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of UtahRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Body Scan Practice

Mindful Breathing Practice

Mindfulness of Discomfort Practice

Mindful Savoring Practice

Integrative Health Recording

Arm Description

Outcomes

Primary Outcome Measures

Acceptability
75% of patients that begin an audio recording will listen to the full, 5-minute recording

Secondary Outcome Measures

Change in Pain
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.
Change in Anxiety
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.
Change in Depression
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.

Full Information

First Posted
June 21, 2022
Last Updated
October 7, 2022
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT05433636
Brief Title
Mindful Waiting Room
Official Title
Idle Waiting or Meditating: Does a Brief, Mindfulness Intervention in the Clinic Waiting Room Improve Patient Outcomes?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2022 (Actual)
Primary Completion Date
September 14, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety State, Depressive State, Pain, Nausea, Fatigue, Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
305 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Body Scan Practice
Arm Type
Experimental
Arm Title
Mindful Breathing Practice
Arm Type
Experimental
Arm Title
Mindfulness of Discomfort Practice
Arm Type
Experimental
Arm Title
Mindful Savoring Practice
Arm Type
Experimental
Arm Title
Integrative Health Recording
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Body Scan
Intervention Description
Patients will listen to a 5-minute, audio-recorded body scan practice.
Intervention Type
Behavioral
Intervention Name(s)
Mindful Breathing
Intervention Description
Patients will listen to a 5-minute, audio-recorded mindful breathing practice.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness of Discomfort
Intervention Description
Patients will listen to a 5-minute, audio-recorded mindfulness of discomfort practice.
Intervention Type
Behavioral
Intervention Name(s)
Mindful Savoring
Intervention Description
Patients will listen to a 5-minute, audio-recorded mindful savoring practice.
Intervention Type
Behavioral
Intervention Name(s)
Integrative Health Recording
Intervention Description
Patients will listen to a 5-minute, audio-recorded description of integrative health.
Primary Outcome Measure Information:
Title
Acceptability
Description
75% of patients that begin an audio recording will listen to the full, 5-minute recording
Time Frame
A single 5-minute period
Secondary Outcome Measure Information:
Title
Change in Pain
Description
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.
Time Frame
Immediately before to after 5-minute audio recording
Title
Change in Anxiety
Description
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.
Time Frame
Immediately before to after 5-minute audio recording
Title
Change in Depression
Description
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.
Time Frame
Immediately before to after 5-minute audio recording

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam Hanley
Phone
8012134191
Email
adam.hanley@utah.edu
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam W Hanley
Phone
801-213-4191

12. IPD Sharing Statement

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Mindful Waiting Room

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