PainNCT04800354
Brief Nurse-led Mindfulness Based Intervention
A study testing Nurse-led Mindfulness Based Intervention and Nurse-led Pain Psychoeducation in people with Pain and Osteoarthritis, Knee, run by University of Utah at 1 site in United States.
Trial summary
This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The feasibility, acceptability, and clinical effects of the nurse-led, very brief, preoperative mindfulness based intervention for hip and knee replacement patients will be investigated relative to nurse-led preoperative pain… 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?
- Nurse-led Mindfulness Based Intervention and Nurse-led Pain Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2021to 10 Jan 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 arthroplasty
Who cannot join
- 1) Cognitive impairment preventing completion of study procedures.
- 2) Current cancer diagnosis,
- 3) Contralateral knee replaced in the previous 3 months,
- 4) Intent to have contralateral knee 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brief Nurse-led Mindfulness Based Intervention Among Patients Scheduled for Knee and Hip Replacement Surgery
This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The feasibility, acceptability, and clinical effects of the nurse-led, very brief, preoperative mindfulness based intervention for hip and knee replacement patients will be investigated relative to nurse-led preoperative pain psychoeducation.
A secondary sub-analysis will compare two different styles of mindfulness practice (mindfulness of breath vs. mindfulness of pain) relative to preoperative pain psychoeducation.
- Conditions
- Pain, Osteoarthritis, Knee, Osteoarthritis, Hip
- Being tested
- Nurse-led Mindfulness Based Intervention, Nurse-led Pain Psychoeducation
- 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.
Nurse-led 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 they experience intense pain or take pain medication before and after surgery.
Nurse-led Pain PsychoeducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-led Mindfulness Based Intervention | Experimental | Not described Receives: Behavioral: Nurse-led Mindfulness Based Intervention; Behavioral: Nurse-led Pain Psychoeducation |
| Nurse-led Pain Psychoeducation | Active comparator | Not described Receives: Behavioral: Nurse-led Pain Psychoeducation |
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 15 minute preoperative nurse visit
Secondary outcomes (3)
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 15 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 15 minute preoperative nurse visit
Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0
The PROMIS physical functioning computer assisted test draws from a bank of 123 items all scored on a 5 point Likert scale.
T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A high score better physical functioning.
Measured: During the 6 weeks prior to surgery and at the 6-week outpatient follow-up appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start22 Feb 2021
- Primary completion20 May 2021
- Study completion10 Jan 2022
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
- 127 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
- NCT04800354
- Sponsor's protocol ID
- IRB_00085446: AM_00040605
- Status last verified
- Jan 2022
- First submitted
- 7 Mar 2021
- Last updated
- 11 Jan 2022
- 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 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Nurse-led Mindfulness Based Intervention Among Patients Scheduled for Knee and Hip Replacement Surgery
- ClinicalTrials.gov ID
- NCT04800354
- Acronym / sponsor ID
- IRB_00085446: AM_00040605
- Conditions
- Pain, Osteoarthritis, Knee, Osteoarthritis, Hip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 16 Mar 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, two-arm, parallel-group randomized clinical trial (RCT). The feasibility, acceptability, and clinical effects of the nurse-led, very brief, preoperative mindfulness based intervention for hip and knee replacement patients will be investigated relative to nurse-led preoperative pain psychoeducation.
A secondary sub-analysis will compare two different styles of mindfulness practice (mindfulness of breath vs. mindfulness of pain) relative to preoperative pain psychoeducation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse-led Mindfulness Based Intervention | Experimental | Behavioral: Nurse-led Mindfulness Based Intervention, Behavioral: Nurse-led Pain Psychoeducation |
| Nurse-led Pain Psychoeducation | Active comparator | Behavioral: Nurse-led Pain Psychoeducation |
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 arthroplasty
Key exclusion criteria (6 listed)
- 1) Cognitive impairment preventing completion of study procedures.
- 2) Current cancer diagnosis,
- 3) Contralateral knee replaced in the previous 3 months,
- 4) Intent to have contralateral knee 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 |
|---|---|---|
| Nurse-led 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 they experience intense pain or take pain medication before and after surgery. | Behavioural | Nurse-led Mindfulness Based Intervention |
| Nurse-led Pain PsychoeducationNurses 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 | Nurse-led Mindfulness Based Intervention, Nurse-led Pain Psychoeducation |
Primary outcome
Change in Pain Intensity Numeric Rating Scale
Time frame: baseline and after the 15 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.
3 secondary outcomes
Change in Pain Unpleasantness Numeric Rating Scale
Time frame: baseline and after the 15 minute preoperative nurse visit
Change in Pain Medication Desire Numeric Rating Scale
Time frame: baseline and after the 15 minute preoperative nurse visit
Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0
Time frame: During the 6 weeks prior to surgery and at the 6-week outpatient follow-up appointment
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 11 Jan 2022.
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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 Nurse-led Mindfulness Based Intervention and Nurse-led Pain Psychoeducation in people with Pain and Osteoarthritis, Knee, 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 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: finished, as of the sponsor's last update on 11 Jan 2022. 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 Intensity Numeric Rating Scale (time frame: baseline and after the 15 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 11 Jan 2022.