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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05433636
Other study ID # 00085446_AM_00042941
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 14, 2022
Est. completion date December 1, 2024

Study information

Verified date February 2024
Source University of Utah
Contact Adam Hanley
Phone 8012134191
Email adam.hanley@utah.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 305
Est. completion date December 1, 2024
Est. primary completion date September 14, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
United States University of Utah Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acceptability 75% of patients that begin an audio recording will listen to the full, 5-minute recording A single 5-minute period
Secondary 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. Immediately before to after 5-minute audio recording
Secondary 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. Immediately before to after 5-minute audio recording
Secondary 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. Immediately before to after 5-minute audio recording
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