PainNCT05634278
Mindfulness Intervention in Orthopedic Trauma Patients
A study testing Preoperative mindfulness, Postoperative mindfulness and Mind wandering in people with Pain and Anxiety, run by University of Utah at 1 site in United States.
Trial summary
This project a single-site 3-arm parallel group randomized clinical trial conducted at a tertiary level 1 trauma center among patients undergoing operative fixation of a lower extremity fracture. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Preoperative mindfulness, Postoperative mindfulness and Mind wandering
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2022to 27 Nov 2023
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at presentation between 18 and 65 years
- Acute lower extremity fracture to be operatively managed
- Glasgow Coma Scale of 15
- English speaking
- Willingness to participate in study
Who cannot join
- Cognitive impairment
- Pregnant or lactating woman
- Current incarceration
- Planned secondary procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot RCT of Mindfulness Intervention in Orthopedic Trauma Patients
This project a single-site 3-arm parallel group randomized clinical trial conducted at a tertiary level 1 trauma center among patients undergoing operative fixation of a lower extremity fracture.
- Being tested
- Preoperative mindfulness, Postoperative mindfulness, Mind wandering
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative mindfulnessBehavioural
A seven-minute, audio-guided, mindfulness meditation practice.
Postoperative mindfulnessBehavioural
A seven-minute, audio-guided, mindfulness meditation practice.
Mind wanderingBehavioural
A timed, seven-minute mind wandering period during which participants are instructed: "For the next 7 minutes, allow your mind to wander."
| Study group | Role | What they receive |
|---|---|---|
| Mind wandering | Placebo comparator | Not described Receives: Behavioral: Mind wandering |
| Preoperative Mindfulness | Active comparator | Participants will only listen to the guided meditation practice before surgery. Receives: Behavioral: Preoperative mindfulness; Behavioral: Mind wandering |
| Preoperative and Postoperative Mindfulness | Active comparator | Participant will listen to the guided meditation practice before surgery and during their hospital stay after surgery. Receives: Behavioral: Preoperative mindfulness; Behavioral: Postoperative mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Preoperative Anxiety
Single item assessing pain unpleasantness ("How nervous, anxious, or on edge do you feel?") 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 the 7-minute preoperative intervention
Change in Postoperative, In-patient 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 the 7-minute postoperative intervention
Secondary outcomes (4)
Change in Preoperative 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 the 7-minute preoperative intervention
Change in Postoperative, In-patient 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 the 7-minute postoperative intervention
Change in Preoperative 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 the 7-minute preoperative intervention
Change in Postoperative, In-patient Anxiety
Single item assessing pain unpleasantness ("How nervous, anxious, or on edge do you feel?") 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 the 7-minute postoperative intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start14 Nov 2022
- Primary completion21 Sep 2023
- Study completion27 Nov 2023
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.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 94 participants (actual)
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
- NCT05634278
- Sponsor's protocol ID
- IRB_00085446 AM_00046459
- Status last verified
- Jun 2025
- First submitted
- 21 Nov 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
- Pilot RCT of Mindfulness Intervention in Orthopedic Trauma Patients
- ClinicalTrials.gov ID
- NCT05634278
- Acronym / sponsor ID
- IRB_00085446 AM_00046459
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 21 Sep 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 2 Dec 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 project a single-site 3-arm parallel group randomized clinical trial conducted at a tertiary level 1 trauma center among patients undergoing operative fixation of a lower extremity fracture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mind wandering | Placebo comparator | Behavioral: Mind wandering |
| Preoperative Mindfulness | Active comparator | Behavioral: Preoperative mindfulness, Behavioral: Mind wanderingParticipants will only listen to the guided meditation practice before surgery. |
| Preoperative and Postoperative Mindfulness | Active comparator | Behavioral: Preoperative mindfulness, Behavioral: Postoperative mindfulnessParticipant will listen to the guided meditation practice before surgery and during their hospital stay after surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age at presentation between 18 and 65 years
- Acute lower extremity fracture to be operatively managed
- Glasgow Coma Scale of 15
- English speaking
- Willingness to participate in study
Key exclusion criteria (4 listed)
- Cognitive impairment
- Pregnant or lactating woman
- Current incarceration
- Planned secondary procedure
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 |
|---|---|---|
| Preoperative mindfulnessA seven-minute, audio-guided, mindfulness meditation practice. | Behavioural | Preoperative Mindfulness, Preoperative and Postoperative Mindfulness |
| Postoperative mindfulnessA seven-minute, audio-guided, mindfulness meditation practice. | Behavioural | Preoperative and Postoperative Mindfulness |
| Mind wanderingA timed, seven-minute mind wandering period during which participants are instructed: "For the next 7 minutes, allow your mind to wander." | Behavioural | Mind wandering, Preoperative Mindfulness |
Primary outcome
Change in Preoperative Anxiety
Time frame: Immediately before to after the 7-minute preoperative intervention
Single item assessing pain unpleasantness ("How nervous, anxious, or on edge do you feel?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater anxiety.
Change in Postoperative, In-patient Pain Unpleasantness
Time frame: Immediately before to after the 7-minute postoperative intervention
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.
4 secondary outcomes
Change in Preoperative Pain Intensity
Time frame: Immediately before to after the 7-minute preoperative intervention
Change in Postoperative, In-patient Pain Intensity
Time frame: Immediately before to after the 7-minute postoperative intervention
Change in Preoperative Pain Unpleasantness
Time frame: Immediately before to after the 7-minute preoperative intervention
Change in Postoperative, In-patient Anxiety
Time frame: Immediately before to after the 7-minute postoperative intervention
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 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 Preoperative mindfulness, Postoperative mindfulness and Mind wandering in people with Pain and Anxiety, 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 5 inclusion and 4 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 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. Some participants in this study may receive a placebo. 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 Preoperative Anxiety (time frame: Immediately before to after the 7-minute preoperative intervention). The study lists 2 primary outcomes in all. 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.