PainNCT06171009
Brief Mindfulness Intervention for Orthopedic Patients: Mechanistic Investigation
A study testing Pain Coping Information and Mindful Pain Management in people with Pain, run by Florida State University at 1 site in United States.
Trial summary
This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The analgesic effects of a 4-minute audio-recorded mindfulness intervention for orthopedic patients will be investigated relative to a 4-minute audio-recoding about pain psychoeducation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Pain Coping Information and Mindful Pain Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2024to 18 Jun 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
- Age ≥18
- Seeking treatment at the Tallahassee Orthopedic Center
Who cannot join
- Cognitive impairment preventing completion of study procedures.
- Other unstable illness judged by medical staff to interfere with study involvement.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tallahassee Orthopedic Clinic (TOC)
Tallahassee, Florida, 32308
About this study
Official title: Brief Mindfulness Intervention for Orthopedic Patients in the Clinic Waiting Room: Mechanistic Investigation
This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The analgesic effects of a 4-minute audio-recorded mindfulness intervention for orthopedic patients will be investigated relative to a 4-minute audio-recoding about pain psychoeducation. Analgesic mechanisms of mindfulness will also be investigated.
- Conditions
- Pain
- Being tested
- Pain Coping Information, Mindful Pain Management
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Coping InformationBehavioural
A 4-minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery).
Mindful Pain ManagementBehavioural
A 4-minute audio recording consisting of a 1-minute introduction to mindfulness followed by a 1-minute and 30-second mindful breathing practice and a 1-minute and 30-second mindfulness of pain practice.
| Study group | Role | What they receive |
|---|---|---|
| Pain Coping Information | Active comparator | Not described Receives: Behavioral: Pain Coping Information |
| Mindful Pain Management | Experimental | Not described Receives: Behavioral: Mindful Pain Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Unpleasantness Numeric Rating Scale
Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.
Measured: Immediately before to after 4-minute audio recording
Secondary outcomes (3)
Change in Pain Intensity Numeric Rating Scale
Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.
Measured: Immediately before to after 4-minute audio recording
Change in Decentering
Decentering will be measured by the single, decentering item from the state version of the validated Metacognitive Processes of Decentering Scale. This item will be scored with a Likert scale item ranging from 0-10, with higher scores representing greater decentering.
Measured: Immediately before to after 4-minute audio recording
Change in Self-Transcendent State
Self-transcendent state will be measured by the three-item, state version of the validated Nondual Awareness Dimensional Assessment. These three items will be scored with a Likert scale item ranging from 0-10, with higher scores representing greater self-transcendence.
Measured: Immediately before to after 4-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 posted14 Dec 2023
- Study start15 May 2024
- Primary completion18 Jun 2024
- Study completion18 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Hanley, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171009
- Sponsor's protocol ID
- STUDY00004419
- Status last verified
- Sep 2024
- First submitted
- 6 Dec 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hanley AW, Gibson R, Davis A, Stecher C, Childs K, Worts P. Mindfulness in the Orthopedic Clinic Waiting Room Decreases Pain: Results From A Randomized Controlled Trial. Int J Behav Med. 2025 Nov 10. doi: 10.1007/s12529-025-10398-3. Online ahead of print.
PubMed 41214294
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Mindfulness Intervention for Orthopedic Patients in the Clinic Waiting Room: Mechanistic Investigation
- ClinicalTrials.gov ID
- NCT06171009
- Acronym / sponsor ID
- STUDY00004419
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 18 Jun 2024 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 14 Dec 2023 (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 is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The analgesic effects of a 4-minute audio-recorded mindfulness intervention for orthopedic patients will be investigated relative to a 4-minute audio-recoding about pain psychoeducation. Analgesic mechanisms of mindfulness will also be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain Coping Information | Active comparator | Behavioral: Pain Coping Information |
| Mindful Pain Management | Experimental | Behavioral: Mindful Pain Management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥18
- Seeking treatment at the Tallahassee Orthopedic Center
Key exclusion criteria (2 listed)
- Cognitive impairment preventing completion of study procedures.
- Other unstable illness judged by medical staff to interfere with study involvement.
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 |
|---|---|---|
| Pain Coping InformationA 4-minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery). | Behavioural | Pain Coping Information |
| Mindful Pain ManagementA 4-minute audio recording consisting of a 1-minute introduction to mindfulness followed by a 1-minute and 30-second mindful breathing practice and a 1-minute and 30-second mindfulness of pain practice. | Behavioural | Mindful Pain Management |
Primary outcome
Change in Pain Unpleasantness Numeric Rating Scale
Time frame: Immediately before to after 4-minute audio recording
Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.
3 secondary outcomes
Change in Pain Intensity Numeric Rating Scale
Time frame: Immediately before to after 4-minute audio recording
Change in Decentering
Time frame: Immediately before to after 4-minute audio recording
Change in Self-Transcendent State
Time frame: Immediately before to after 4-minute audio recording
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 41214294Hanley AW, Gibson R, Davis A, Stecher C, Childs K, Worts P. Mindfulness in the Orthopedic Clinic Waiting Room Decreases Pain: Results From A Randomized Controlled Trial. Int J Behav Med. 2025 Nov 10. doi: 10.1007/s12529-025-10398-3. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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 Pain Coping Information and Mindful Pain Management in people with Pain, run by Florida State University 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: finished, as of the sponsor's last update on 19 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Numeric Rating Scale (time frame: Immediately before to after 4-minute audio recording). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06171009, which also lists 1 linked publication.
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 19 Sep 2024.