Pain, AcuteNCT04520958
Preoperative Psychosocial Support for Postoperative Recovery and Health: Mechanistic Substudy
A study testing Mindfulness of Breath, Mindfulness of Pain and Cognitive-Behaviorally Based Pain Psychoeducation in people with Pain, Acute and Pain, Joint, run by University of Utah at 1 site in United States.
Trial summary
This was a single site, three-arm, parallel group randomized clinical trial that compared the effect of three preoperative psychosocial interventions on knee and hip replacement patients' preoperative pain intensity and postoperative pain intensity, pain unpleasantness, and opioid use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Acute, Pain, Joint, Pain
- What is being tested?
- Mindfulness of Breath, Mindfulness of Pain and Cognitive-Behaviorally Based Pain Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2019to 13 Aug 2020
- 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 Joint 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
This was a single site, three-arm, parallel group randomized clinical trial that compared the effect of three preoperative psychosocial interventions on knee and hip replacement patients' preoperative pain intensity and postoperative pain intensity, pain unpleasantness, and opioid use.
- Conditions
- Pain, Acute, Pain, Joint, Pain
- Being tested
- Mindfulness of Breath, Mindfulness of Pain, Cognitive-Behaviorally Based Pain Psychoeducation
- Medical subject headings
- Acute Pain, Arthralgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness of BreathBehavioural
Mindfulness of Breath consisted of instruction in focused attention on the breath and metacognitive monitoring and acceptance of discursive thoughts, negative emotions, and pain.
Mindfulness of PainBehavioural
Mindfulness of Pain consisted of instruction in how to (1) zoom in to deconstruct pain into its constituent physical sensations and precisely map each sensation's spatial location, (2) use mindful breathing to zoom out and broaden the field of attention to include previously neglected sensory elements (i.e., spaces within the body that were absent of sensation and pleasant sensations), and (3) shift attention from unpleasant sensations to neutral/pleasant sensations or experiences.
Cognitive-Behaviorally Based Pain PsychoeducationBehavioural
Cognitive-Behaviorally Based Pain Psychoeducation consisted of psychoeducation about the link between thoughts, emotions, and behavior and provided instruction in the use logic to dispute maladaptive thoughts about pain that might otherwise exacerbate pain and distress.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness of Breath | Experimental | Not described Receives: Behavioral: Mindfulness of Breath |
| Mindfulness of Pain | Experimental | Not described Receives: Behavioral: Mindfulness of Pain |
| Cognitive-Behaviorally Based Pain Psychoeducation | Active comparator | Not described Receives: Behavioral: Cognitive-Behaviorally Based Pain Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Preoperative Pain Intensity
Single-item Numeric Rating Scale (0-10), with 0 indicating no pain and 10 representing the most intense pain imaginable.
Measured: Completed immediately before the preoperative intervention and immediately after the preoperative intervention (i.e., 20 minutes)
Change in Postoperative Pain Intensity
Single-item Numeric Rating Scale (0-10), with 0 indicating no pain and 10 representing the most intense pain imaginable.
Measured: Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.
Secondary outcomes (2)
Change in Postoperative Pain Unpleasantness
Single-item Numeric Rating Scale (0-10), with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.
Measured: Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.
Change in Postoperative Opioid Use
Single-item, dichotomously scored (no vs. yes): "Did you take opioid medications in the last 24 hours?"
Measured: Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start29 Oct 2019
- Primary completion10 Mar 2020
- Study completion13 Aug 2020
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 Pain, AcuteStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 118 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
- NCT04520958
- Sponsor's protocol ID
- IRB_00123611
- Status last verified
- Oct 2019
- First submitted
- 13 Aug 2020
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Psychosocial Support for Postoperative Recovery and Health: Mechanistic Substudy
- ClinicalTrials.gov ID
- NCT04520958
- Acronym / sponsor ID
- IRB_00123611
- Conditions
- Pain, Acute, Pain, Joint, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 29 Oct 2019 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 13 Aug 2020 (actual)
- First posted
- 20 Aug 2020 (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 was a single site, three-arm, parallel group randomized clinical trial that compared the effect of three preoperative psychosocial interventions on knee and hip replacement patients' preoperative pain intensity and postoperative pain intensity, pain unpleasantness, and opioid use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness of Breath | Experimental | Behavioral: Mindfulness of Breath |
| Mindfulness of Pain | Experimental | Behavioral: Mindfulness of Pain |
| Cognitive-Behaviorally Based Pain Psychoeducation | Active comparator | Behavioral: Cognitive-Behaviorally Based Pain Psychoeducation |
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 Joint 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 |
|---|---|---|
| Mindfulness of BreathMindfulness of Breath consisted of instruction in focused attention on the breath and metacognitive monitoring and acceptance of discursive thoughts, negative emotions, and pain. | Behavioural | Mindfulness of Breath |
| Mindfulness of PainMindfulness of Pain consisted of instruction in how to (1) zoom in to deconstruct pain into its constituent physical sensations and precisely map each sensation's spatial location, (2) use mindful breathing to zoom out and broaden the field of attention to include previously neglected sensory elements (i.e., spaces within the body that were absent of sensation and pleasant sensations), and (3) shift attention from unpleasant sensations to neutral/pleasant sensations or experiences. | Behavioural | Mindfulness of Pain |
| Cognitive-Behaviorally Based Pain PsychoeducationCognitive-Behaviorally Based Pain Psychoeducation consisted of psychoeducation about the link between thoughts, emotions, and behavior and provided instruction in the use logic to dispute maladaptive thoughts about pain that might otherwise exacerbate pain and distress. | Behavioural | Cognitive-Behaviorally Based Pain Psychoeducation |
Primary outcome
Change in Preoperative Pain Intensity
Time frame: Completed immediately before the preoperative intervention and immediately after the preoperative intervention (i.e., 20 minutes)
Single-item Numeric Rating Scale (0-10), with 0 indicating no pain and 10 representing the most intense pain imaginable.
Change in Postoperative Pain Intensity
Time frame: Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.
Single-item Numeric Rating Scale (0-10), with 0 indicating no pain and 10 representing the most intense pain imaginable.
2 secondary outcomes
Change in Postoperative Pain Unpleasantness
Time frame: Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.
Change in Postoperative Opioid Use
Time frame: Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.
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 Aug 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.
- Individual participant dataSharing planned: No
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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 of Breath, Mindfulness of Pain and Cognitive-Behaviorally Based Pain Psychoeducation in people with Pain, Acute and Pain, Joint, 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 Aug 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?
Change in Preoperative Pain Intensity (time frame: Completed immediately before the preoperative intervention and immediately after the preoperative intervention (i.e., 20 minutes)). 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 NCT04520958, 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 Aug 2020.