PainNCT05054595
Audio-Recorded vs. Nurse-Led Brief Mindfulness-Based Intervention
A study testing Standard Pain Management, Audio-Recorded Mindfulness-Based Intervention and Nurse-Led Mindfulness-Based Intervention in people with Pain and Osteoarthritis, Knee, run by University of Utah.
Trial summary
This is a single-site, three-arm, parallel-group randomized clinical trial (RCT). The clinical effects of a nurse-led, very brief, preoperative mindfulness-based intervention for hip and knee replacement patients will be investigated relative to an audio-recorded very brief, preoperative mindfulness-based intervention… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Osteoarthritis, Knee, Osteoarthritis, Hip
- What is being tested?
- Standard Pain Management, Audio-Recorded Mindfulness-Based Intervention and Nurse-Led Mindfulness-Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2021to 20 Sep 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Age ≥18,
- 2) Scheduled to undergo unilateral total knee or hip arthroplasty
Who cannot join
- 1) Cognitive impairment preventing completion of study procedures.
- 2) Current cancer diagnosis,
- 3) Contralateral knee or hip replaced in the previous 3 months,
- 4) Intent to have contralateral knee or hip replaced or other, additional surgical procedure during the study period,
- 5) Intent to add new pain treatments during the study period (except for what is part of the study),
- 6) Other unstable illness judged by medical staff to interfere with study treatment.
About this study
Official title: Comparing the Effects of an Audio-Recorded Brief Mindfulness-Based Intervention With a Nurse-Led Brief Mindfulness-Based Intervention for Preoperative Knee and Hip Replacement Patients
This is a single-site, three-arm, parallel-group randomized clinical trial (RCT). The clinical effects of a nurse-led, very brief, preoperative mindfulness-based intervention for hip and knee replacement patients will be investigated relative to an audio-recorded very brief, preoperative mindfulness-based intervention delivered during the standard nurse consult and a nurse-led preoperative pain psychoeducation intervention during the standard nurse consult.
- Conditions
- Pain, Osteoarthritis, Knee, Osteoarthritis, Hip
- Being tested
- Standard Pain Management, Audio-Recorded Mindfulness-Based Intervention, Nurse-Led Mindfulness-Based Intervention
- Medical subject headings
- Pain, Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Pain ManagementBehavioural
Nurses will provide psychoeducation about pain along with common pain coping strategies, such as rest, ice, and elevation, for use any time they experience intense pain or take pain medication before and after surgery.
Audio-Recorded Mindfulness-Based InterventionBehavioural
Nurses will read patients a brief (1 minute) scripted, introduction to mindfulness and then have them listen to a very brief (1 minute 30 second) guided mindfulness practice validated in our prior research to encourage focused attention on breath and body sensations and open monitoring and acceptance of discursive thoughts, negative emotions, and pain. Finally, patients will be given an audio recording of the mindful pain management technique for use any time.
Nurse-Led Mindfulness-Based InterventionBehavioural
Nurses will read patients a brief (1 minute) scripted, introduction to mindfulness and then guide them through a very brief (1 minute 30 second) mindfulness practice validated in our prior research to encourage focused attention on breath and body sensations and open monitoring and acceptance of discursive thoughts, negative emotions, and pain. Finally, patients will be given an audio recording of the mindful pain management technique for use any time.
| Study group | Role | What they receive |
|---|---|---|
| Standard Pain Psychoeducation | Active comparator | Not described Receives: Behavioral: Standard Pain Management |
| Audio-Recorded Mindfulness-Based Intervention | Active comparator | Not described Receives: Behavioral: Audio-Recorded Mindfulness-Based Intervention |
| Nurse-Led Mindfulness-Based Intervention | Experimental | Not described Receives: Behavioral: Nurse-Led Mindfulness-Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Baseline and after the 10 minute preoperative nurse visit
Secondary outcomes (2)
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: Baseline and after the 10 minute preoperative nurse visit
Change in Pain Medication Desire Numeric Rating Scale
Single Likert scale item ranging from 0-10, with 0 indicating no desire for pain medication and 10 representing a strong desire for pain medication.
Measured: Baseline and after the 10 minute preoperative nurse visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start20 Sep 2021 (estimated)
- Primary completion20 Feb 2022 (estimated)
- Study completion20 Sep 2022 (estimated)
Why it stopped: Lack of provider bandwidth
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
- 0 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
- NCT05054595
- Sponsor's protocol ID
- IRB_00085446: AM_00040605 2
- Status last verified
- Mar 2023
- First submitted
- 13 Sep 2021
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effects of an Audio-Recorded Brief Mindfulness-Based Intervention With a Nurse-Led Brief Mindfulness-Based Intervention for Preoperative Knee and Hip Replacement Patients
- ClinicalTrials.gov ID
- NCT05054595
- Acronym / sponsor ID
- IRB_00085446: AM_00040605 2
- Conditions
- Pain, Osteoarthritis, Knee, Osteoarthritis, Hip
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of provider bandwidth
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 20 Sep 2021 (estimated)
- Primary completion
- 20 Feb 2022 (estimated)
- Study completion
- 20 Sep 2022 (estimated)
- First posted
- 23 Sep 2021 (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, three-arm, parallel-group randomized clinical trial (RCT). The clinical effects of a nurse-led, very brief, preoperative mindfulness-based intervention for hip and knee replacement patients will be investigated relative to an audio-recorded very brief, preoperative mindfulness-based intervention delivered during the standard nurse consult and a nurse-led preoperative pain psychoeducation intervention during the standard nurse consult.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Pain Psychoeducation | Active comparator | Behavioral: Standard Pain Management |
| Audio-Recorded Mindfulness-Based Intervention | Active comparator | Behavioral: Audio-Recorded Mindfulness-Based Intervention |
| Nurse-Led Mindfulness-Based Intervention | Experimental | Behavioral: Nurse-Led Mindfulness-Based Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1) Age ≥18,
- 2) Scheduled to undergo unilateral total knee or hip arthroplasty
Key exclusion criteria (6 listed)
- 1) Cognitive impairment preventing completion of study procedures.
- 2) Current cancer diagnosis,
- 3) Contralateral knee or hip replaced in the previous 3 months,
- 4) Intent to have contralateral knee or hip replaced or other, additional surgical procedure during the study period,
- 5) Intent to add new pain treatments during the study period (except for what is part of the study),
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 |
|---|---|---|
| Standard Pain ManagementNurses will provide psychoeducation about pain along with common pain coping strategies, such as rest, ice, and elevation, for use any time they experience intense pain or take pain medication before and after surgery. | Behavioural | Standard Pain Psychoeducation |
| Audio-Recorded Mindfulness-Based InterventionNurses will read patients a brief (1 minute) scripted, introduction to mindfulness and then have them listen to a very brief (1 minute 30 second) guided mindfulness practice validated in our prior research to encourage focused attention on breath and body sensations and open monitoring and acceptance of discursive thoughts, negative emotions, and pain. Finally, patients will be given an audio recording of the mindful pain management technique for use any time. | Behavioural | Audio-Recorded Mindfulness-Based Intervention |
| Nurse-Led Mindfulness-Based InterventionNurses will read patients a brief (1 minute) scripted, introduction to mindfulness and then guide them through a very brief (1 minute 30 second) mindfulness practice validated in our prior research to encourage focused attention on breath and body sensations and open monitoring and acceptance of discursive thoughts, negative emotions, and pain. Finally, patients will be given an audio recording of the mindful pain management technique for use any time. | Behavioural | Nurse-Led Mindfulness-Based Intervention |
Primary outcome
Change in Pain Intensity Numeric Rating Scale
Time frame: Baseline and after the 10 minute preoperative nurse visit
Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.
2 secondary outcomes
Change in Pain Unpleasantness Numeric Rating Scale
Time frame: Baseline and after the 10 minute preoperative nurse visit
Change in Pain Medication Desire Numeric Rating Scale
Time frame: Baseline and after the 10 minute preoperative nurse visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Pain Management, Audio-Recorded Mindfulness-Based Intervention and Nurse-Led Mindfulness-Based Intervention in people with Pain and Osteoarthritis, Knee, run by University of Utah.
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 6 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: withdrawn, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 Intensity Numeric Rating Scale (time frame: Baseline and after the 10 minute preoperative nurse visit). 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 31 Mar 2023.