Mindful Waiting Room

Sponsor

University of Utah (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05433636

Collaborator

(none)

305

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This will be a single-site, five-arm, parallel group randomized control trial involving patients seeking integrative healthcare. We will compare four different styles of 5-minute, audio-recoded mindfulness practices delivered in the clinic waiting room to 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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety State Depressive State Pain Nausea Fatigue Cancer	Behavioral: Body Scan Behavioral: Mindful Breathing Behavioral: Mindfulness of Discomfort Behavioral: Mindful Savoring Behavioral: Integrative Health Recording	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

305 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Idle Waiting or Meditating: Does a Brief, Mindfulness Intervention in the Clinic Waiting Room Improve Patient Outcomes?

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Body Scan Practice	Behavioral: Body Scan Patients will listen to a 5-minute, audio-recorded body scan practice.
Experimental: Mindful Breathing Practice	Behavioral: Mindful Breathing Patients will listen to a 5-minute, audio-recorded mindful breathing practice.
Experimental: Mindfulness of Discomfort Practice	Behavioral: Mindfulness of Discomfort Patients will listen to a 5-minute, audio-recorded mindfulness of discomfort practice.
Experimental: Mindful Savoring Practice	Behavioral: Mindful Savoring Patients will listen to a 5-minute, audio-recorded mindful savoring practice.
Active Comparator: Integrative Health Recording	Behavioral: Integrative Health Recording Patients will listen to a 5-minute, audio-recorded description of integrative health.

Outcome Measures

Primary Outcome Measures

Acceptability [A single 5-minute period]
80% of patients that begin an audio recording will listen to the full, 5-minute recording

Secondary Outcome Measures

Change in Decentering [Immediately before to after 5-minute audio recording]
Adaptation of the decentering item from the state version of the Metacognitive Processes of Decentering Scale ("I was able to watch thoughts, emotions, and sensations come and go") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater decentering.
Change in Self-Transcendence [Immediately before to after 5-minute audio recording]
Single item from the state version of the Nondual Awareness Dimensional Assessment ("I experienced all sense of self and identity dissolve away") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater self-transcendence.
Change in Fatigue [Immediately before to after 5-minute audio recording]
Single item assessing fatigue ("Right now, I feel fatigued or worn-out") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater fatigue.
Change in Nausea [Immediately before to after 5-minute audio recording]
Single item assessing nausea ("Right now, I feel nauseous") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater nausea.
Change in Pain [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.
Change in Anxiety [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.
Change in Depression [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Utah

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Adam Hanley, Assistant Professor, University of Utah

ClinicalTrials.gov Identifier:

NCT05433636

Other Study ID Numbers:

00085446_AM_00042941

First Posted:

Jun 27, 2022

Last Update Posted:

Jun 27, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fatigue

Depression

Study Results

No Results Posted as of Jun 27, 2022