PainNCT05433389
App Delivered Brief Mindfulness Intervention for Surgical Patients
A study testing Breath Counting, Body Scan and Mindful Breathing in people with Pain and Anxiety 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 undergoing knee or hip replacement surgery. The investigators will compare five different styles of 5-minute, audio-recoded mindfulness practices delivered via app 7 days before to surgery, 2 days before to surgery, 2 days… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Anxiety State, Depressive State
- What is being tested?
- Breath Counting, Body Scan and Mindful Breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 823 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2022to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18,
- Scheduled to undergo total joint arthroplasty of the knee or hip
Who cannot join
- Inability to read English
- Cognitive impairment preventing completion of study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: App Delivered Brief Mindfulness Intervention for Knee or Hip Replacement Patients
This will be a single-site, five-arm, parallel group randomized control trial involving patients undergoing knee or hip replacement surgery. The investigators will compare five different styles of 5-minute, audio-recoded mindfulness practices delivered via app 7 days before to surgery, 2 days before to surgery, 2 days after surgery, and 6 days after surgery.
- Conditions
- Pain, Anxiety State, Depressive State
- Being tested
- Breath Counting, Body Scan, Mindful Breathing, Mindfulness of Pain, Mindful Savoring
- Medical subject headings
- Pain, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath CountingBehavioural
Patients will listen to a 5-minute, audio-recorded breath counting practice.
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 PainBehavioural
Patients will listen to a 5-minute, audio-recorded mindfulness of pain practice.
Mindful SavoringBehavioural
Patients will listen to a 5-minute, audio-recorded mindful savoring practice.
| Study group | Role | What they receive |
|---|---|---|
| Breath Counting | Active comparator | Not described Receives: Behavioral: Breath Counting |
| Body Scan | Experimental | Not described Receives: Behavioral: Body Scan |
| Mindful Breathing | Experimental | Not described Receives: Behavioral: Mindful Breathing |
| Mindfulness of Pain | Experimental | Not described Receives: Behavioral: Mindfulness of Pain |
| Mindful Savoring | Experimental | Not described Receives: Behavioral: Mindful Savoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Unpleasantness
Single item assessing pain unpleasantness ("How unpleasant is your pain?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater pain unpleasantness.
Measured: Immediately before to after 5-minute audio recording
Secondary outcomes (2)
Change in Pain Intensity
Single item assessing pain intensity ("How much pain do you have?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater pain intensity.
Measured: Immediately before to after 5-minute audio recording
Change in Pain Medication Desire
Single item assessing pain unpleasantness ("How much do you want pain medicine?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater desire for pain medicine.
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 start21 Jun 2022
- Primary completion26 May 2025
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- 823 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
- NCT05433389
- Sponsor's protocol ID
- 00085446 AM_00032203
- Status last verified
- Jun 2025
- First submitted
- 21 Jun 2022
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- App Delivered Brief Mindfulness Intervention for Knee or Hip Replacement Patients
- ClinicalTrials.gov ID
- NCT05433389
- Acronym / sponsor ID
- 00085446 AM_00032203
- Conditions
- Pain, Anxiety State, Depressive State
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 823 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 26 May 2025 (actual)
- Study completion
- 1 Nov 2025 (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 undergoing knee or hip replacement surgery. The investigators will compare five different styles of 5-minute, audio-recoded mindfulness practices delivered via app 7 days before to surgery, 2 days before to surgery, 2 days after surgery, and 6 days after surgery.
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 |
|---|---|---|
| Breath Counting | Active comparator | Behavioral: Breath Counting |
| Body Scan | Experimental | Behavioral: Body Scan |
| Mindful Breathing | Experimental | Behavioral: Mindful Breathing |
| Mindfulness of Pain | Experimental | Behavioral: Mindfulness of Pain |
| Mindful Savoring | Experimental | Behavioral: Mindful Savoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥18,
- Scheduled to undergo total joint arthroplasty of the knee or hip
Key exclusion criteria (2 listed)
- Inability to read English
- Cognitive impairment preventing completion of study procedures
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 |
|---|---|---|
| Breath CountingPatients will listen to a 5-minute, audio-recorded breath counting practice. | Behavioural | Breath Counting |
| Body ScanPatients will listen to a 5-minute, audio-recorded body scan practice. | Behavioural | Body Scan |
| Mindful BreathingPatients will listen to a 5-minute, audio-recorded mindful breathing practice. | Behavioural | Mindful Breathing |
| Mindfulness of PainPatients will listen to a 5-minute, audio-recorded mindfulness of pain practice. | Behavioural | Mindfulness of Pain |
| Mindful SavoringPatients will listen to a 5-minute, audio-recorded mindful savoring practice. | Behavioural | Mindful Savoring |
Primary outcome
Change in Pain Unpleasantness
Time frame: Immediately before to after 5-minute audio recording
Single item assessing pain unpleasantness ("How unpleasant is your pain?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater pain unpleasantness.
2 secondary outcomes
Change in Pain Intensity
Time frame: Immediately before to after 5-minute audio recording
Change in Pain Medication Desire
Time frame: Immediately before to after 5-minute audio recording
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breath Counting, Body Scan and Mindful Breathing in people with Pain and Anxiety 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 2 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: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Unpleasantness (time frame: Immediately before to after 5-minute audio recording). 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 17 Jun 2025.