Anxiety StateNCT05433636
Mindful Waiting Room
A study testing Body Scan, Mindful Breathing and Mindfulness of Discomfort in people with Anxiety State and Depressive State, run by University of Utah at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety State, Depressive State, Pain
- What is being tested?
- Body Scan, Mindful Breathing and Mindfulness of Discomfort
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2022to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Seeking treatment at the Huntsman Cancer Institute's Wellness Center
- Adults 18+
- Facility with the English language that is adequate to complete study procedures
Who cannot join
- Cognitive impairment preventing completion of study procedures
- An unstable illness judged by medical staff to interfere with study treatment
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Utah
Salt Lake City, Utah, 84112
Adam W Hanley, 801-213-4191
About this study
Official title: 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.
- Conditions
- Anxiety State, Depressive State, Pain, Nausea, Fatigue, Cancer
- Being tested
- Body Scan, Mindful Breathing, Mindfulness of Discomfort, Mindful Savoring, Integrative Health Recording
- Medical subject headings
- Anxiety Disorders, Depression, Pain, Nausea, Fatigue, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body ScanBehavioural
Patients will listen to a 5-minute, audio-recorded body scan practice.
Mindful BreathingBehavioural
Patients will listen to a 5-minute, audio-recorded mindful breathing practice.
Mindfulness of DiscomfortBehavioural
Patients will listen to a 5-minute, audio-recorded mindfulness of discomfort practice.
Mindful SavoringBehavioural
Patients will listen to a 5-minute, audio-recorded mindful savoring practice.
Integrative Health RecordingBehavioural
Patients will listen to a 5-minute, audio-recorded description of integrative health.
| Study group | Role | What they receive |
|---|---|---|
| Body Scan Practice | Experimental | Not described Receives: Behavioral: Body Scan |
| Mindful Breathing Practice | Experimental | Not described Receives: Behavioral: Mindful Breathing |
| Mindfulness of Discomfort Practice | Experimental | Not described Receives: Behavioral: Mindfulness of Discomfort |
| Mindful Savoring Practice | Experimental | Not described Receives: Behavioral: Mindful Savoring |
| Integrative Health Recording | Active comparator | Not described Receives: Behavioral: Integrative Health Recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
75% of patients that begin an audio recording will listen to the full, 5-minute recording
Measured: A single 5-minute period
Secondary outcomes (3)
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.
Measured: Immediately before to after 5-minute audio recording
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.
Measured: Immediately before to after 5-minute audio recording
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.
Measured: Immediately before to after 5-minute audio recording
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start14 Sep 2022
- Primary completion14 Sep 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 305 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Hanley, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433636
- Sponsor's protocol ID
- 00085446_AM_00042941
- Status last verified
- Feb 2024
- First submitted
- 21 Jun 2022
- Last updated
- 6 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Idle Waiting or Meditating: Does a Brief, Mindfulness Intervention in the Clinic Waiting Room Improve Patient Outcomes?
- ClinicalTrials.gov ID
- NCT05433636
- Acronym / sponsor ID
- 00085446_AM_00042941
- Conditions
- Anxiety State, Depressive State, Pain, Nausea, Fatigue, Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 305 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 14 Sep 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Body Scan Practice | Experimental | Behavioral: Body Scan |
| Mindful Breathing Practice | Experimental | Behavioral: Mindful Breathing |
| Mindfulness of Discomfort Practice | Experimental | Behavioral: Mindfulness of Discomfort |
| Mindful Savoring Practice | Experimental | Behavioral: Mindful Savoring |
| Integrative Health Recording | Active comparator | Behavioral: Integrative Health Recording |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Seeking treatment at the Huntsman Cancer Institute's Wellness Center
- Adults 18+
- Facility with the English language that is adequate to complete study procedures
Key exclusion criteria (2 listed)
- Cognitive impairment preventing completion of study procedures
- An unstable illness judged by medical staff to interfere with study treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body ScanPatients will listen to a 5-minute, audio-recorded body scan practice. | Behavioural | Body Scan Practice |
| Mindful BreathingPatients will listen to a 5-minute, audio-recorded mindful breathing practice. | Behavioural | Mindful Breathing Practice |
| Mindfulness of DiscomfortPatients will listen to a 5-minute, audio-recorded mindfulness of discomfort practice. | Behavioural | Mindfulness of Discomfort Practice |
| Mindful SavoringPatients will listen to a 5-minute, audio-recorded mindful savoring practice. | Behavioural | Mindful Savoring Practice |
| Integrative Health RecordingPatients will listen to a 5-minute, audio-recorded description of integrative health. | Behavioural | Integrative Health Recording |
Primary outcome
Acceptability
Time frame: A single 5-minute period
75% of patients that begin an audio recording will listen to the full, 5-minute recording
3 secondary outcomes
Change in Pain
Time frame: Immediately before to after 5-minute audio recording
Change in Anxiety
Time frame: Immediately before to after 5-minute audio recording
Change in Depression
Time frame: Immediately before to after 5-minute audio recording
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body Scan, Mindful Breathing and Mindfulness of Discomfort in people with Anxiety State and Depressive State, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adam Hanley (8012134191, adam.hanley@utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: A single 5-minute period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.