Acute PainMind-Body JRANCT03665727
Psychosocial Support for Pre-operative Pain and Distress
A study testing Mindfulness, Suggestion and Psychoeducation in people with Acute Pain, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this randomized study is to determine the impact of three different types of psychosocial support delivered by mental health professionals to pre-operative joint replacement patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain
- What is being tested?
- Mindfulness, Suggestion and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 727 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2018to 23 Sep 2019
- 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
- English-speaking males or females
- 18 years old or older
- patients within the University of Utah Hospital system
- patients attending the Joint Replacement Academy to prepare for either hip or knee replacement surgery
Who cannot join
- Altered mental status due to delirium, psychosis, or pharmacological sedation as determined by clinical assessment.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this randomized study is to determine the impact of three different types of psychosocial support delivered by mental health professionals to pre-operative joint replacement patients. This study will examine the differential effects of brief mindfulness training, hypnostic suggestion, and cognitive behavioral pain psychoeducation for pre-operative patients, with a supplemental nonrandomized usual care comparison group.
- Conditions
- Acute Pain
- Being tested
- Mindfulness, Suggestion, Psychoeducation
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
The 15 minute mindfulness session is a scripted mindfulness exercise that incorporates mindfulness principles of intentionally paying attention to present-moment experience in a non-judgmental fashion.
SuggestionBehavioural
The 15 minute suggestion session is a scripted suggestion exercise that incorporates imagery and suggestions for changes in cognition, emotion, and body sensations.
PsychoeducationBehavioural
The 15 minute psychoeducation session is a supportive session in which behavioral coping strategies for pain management are discussed.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Experimental | 15 minute mindfulness session Receives: Behavioral: Mindfulness |
| Suggestion | Experimental | 15 minute therapeutic suggestion session Receives: Behavioral: Suggestion |
| Psychoeducation | Active comparator | 15 minute psychoeducation session Receives: Behavioral: Psychoeducation |
| Usual Care | No intervention | The usual care comparison group was comprised of patients who underwent total joint arthroplasty of the hip or knee at the same academic medical center during the study period but who did not attend Joint Academy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 prior to and following intervention
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 prior to and following intervention
Secondary outcomes (5)
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: Immediately prior to and following intervention
Anxiety Numeric Rating Scale
Single Likert scale item ranging from 0-10, with 0 indicating no anxiety and 10 representing very anxious.
Measured: Immediately prior to and following intervention
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 prioir to surgery and at the 6-week outpatient follow-up appointment.
Nondual Awareness Dimensional Assessment - State
Three Likert scale item ranging from 0-30, with 0 indicating no nondual awareness and 10 representing complete nondual awareness. Items can also be used individually. Item one is a single Likert scale item ranging from 0-10, with 0 indicating no relational unity and 10 representing complete relational unity. Item two is a single Likert scale item ranging from 0-10, with 0 indicating no annihilational unity and 10 representing complete annihilational unity. Item three is a single Likert scale item ranging from 0-10, with 0 indicating no bliss and 10 representing complete bliss.
Measured: Immediately prior to and following intervention
Sensation Manikin Body Sensation Report
The ratio of pleasant to unpleasant bodily sensations reported on a sensation manikin. Ratio scores below 1 indicate unpleasant sensations predominate in the body and ratio scores above 1 indicate pleasant scores predominate.
Measured: Immediately prior to and following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start4 Jun 2018
- Primary completion23 Sep 2019
- Study completion23 Sep 2019
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 Acute 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 727 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Garland, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665727
- Sponsor's protocol ID
- IRB_00085446
- Acronym
- Mind-Body JRA
- Status last verified
- May 2020
- First submitted
- 12 Jun 2018
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hanley AW, Gililland J, Garland EL. To be mindful of the breath or pain: Comparing two brief preoperative mindfulness techniques for total joint arthroplasty patients. J Consult Clin Psychol. 2021 Jul;89(7):590-600. doi: 10.1037/ccp0000657. Epub 2021 Jun 24.
PubMed 34165999
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Support for Pre-operative Pain and Distress
- ClinicalTrials.gov ID
- NCT03665727
- Acronym / sponsor ID
- Mind-Body JRA / IRB_00085446
- Conditions
- Acute Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 727 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 23 Sep 2019 (actual)
- Study completion
- 23 Sep 2019 (actual)
- First posted
- 11 Sep 2018 (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.
The purpose of this randomized study is to determine the impact of three different types of psychosocial support delivered by mental health professionals to pre-operative joint replacement patients. This study will examine the differential effects of brief mindfulness training, hypnostic suggestion, and cognitive behavioral pain psychoeducation for pre-operative patients, with a supplemental nonrandomized usual care comparison group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Behavioral: Mindfulness15 minute mindfulness session |
| Suggestion | Experimental | Behavioral: Suggestion15 minute therapeutic suggestion session |
| Psychoeducation | Active comparator | Behavioral: Psychoeducation15 minute psychoeducation session |
| Usual Care | No intervention | –The usual care comparison group was comprised of patients who underwent total joint arthroplasty of the hip or knee at the same academic medical center during the study period but who did not attend Joint Academy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English-speaking males or females
- 18 years old or older
- patients within the University of Utah Hospital system
- patients attending the Joint Replacement Academy to prepare for either hip or knee replacement surgery
Key exclusion criteria (1 listed)
- Altered mental status due to delirium, psychosis, or pharmacological sedation as determined by clinical assessment.
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 |
|---|---|---|
| MindfulnessThe 15 minute mindfulness session is a scripted mindfulness exercise that incorporates mindfulness principles of intentionally paying attention to present-moment experience in a non-judgmental fashion. | Behavioural | Mindfulness |
| SuggestionThe 15 minute suggestion session is a scripted suggestion exercise that incorporates imagery and suggestions for changes in cognition, emotion, and body sensations. | Behavioural | Suggestion |
| PsychoeducationThe 15 minute psychoeducation session is a supportive session in which behavioral coping strategies for pain management are discussed. | Behavioural | Psychoeducation |
Primary outcome
Pain Intensity Numeric Rating Scale
Time frame: Immediately prior to and following intervention
Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.
Pain Unpleasantness Numeric Rating Scale
Time frame: Immediately prior to and following intervention
Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.
5 secondary outcomes
Pain Medication Desire Numeric Rating Scale
Time frame: Immediately prior to and following intervention
Anxiety Numeric Rating Scale
Time frame: Immediately prior to and following intervention
Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0
Time frame: During the 6 weeks prioir to surgery and at the 6-week outpatient follow-up appointment.
Nondual Awareness Dimensional Assessment - State
Time frame: Immediately prior to and following intervention
Sensation Manikin Body Sensation Report
Time frame: Immediately prior to and following 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 27 May 2020.
- Derived from this study: PubMed 34165999Hanley AW, Gililland J, Garland EL. To be mindful of the breath or pain: Comparing two brief preoperative mindfulness techniques for total joint arthroplasty patients. J Consult Clin Psychol. 2021 Jul;89(7):590-600. doi: 10.1037/ccp0000657. Epub 2021 Jun 24.
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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 Mindfulness, Suggestion and Psychoeducation in people with Acute Pain, 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 4 inclusion and 1 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 27 May 2020. 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?
Pain Intensity Numeric Rating Scale (time frame: Immediately prior to and following 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?
On the ClinicalTrials.gov record for NCT03665727, 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 27 May 2020.