PainNCT04477278
Examining the Impact of Mindfulness on Patients' Experience of Osteopathic Manipulation
A study testing Mindfulness Meditation and History of Osteopathy in people with Pain and Satisfaction, Patient, run by University of Utah at 1 site in United States.
Trial summary
This is a single site, two-arm, parallel group pilot randomized controlled trial examining the effect of coupling a brief mindfulness-based intervention with an osteopathic manipulation session for pain patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Satisfaction, Patient
- What is being tested?
- Mindfulness Meditation and History of Osteopathy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2019to 23 Jun 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients scheduled for OMT at the Huntsman Cancer Institute
Who cannot join
- Altered mental status due to delirium, psychosis, or medication sedation as determined by treating clinician.
Trial locations and contacts
1 site in 1 country.
About this study
This is a single site, two-arm, parallel group pilot randomized controlled trial examining the effect of coupling a brief mindfulness-based intervention with an osteopathic manipulation session for pain patients.
- Conditions
- Pain, Satisfaction, Patient
- Being tested
- Mindfulness Meditation, History of Osteopathy
- Medical subject headings
- Pain, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness MeditationBehavioural
The mindfulness meditation recording consisted of instruction in focused attention on breath and body sensations and metacognitive monitoring and acceptance of discursive thoughts, negative emotions, and pain.
History of OsteopathyBehavioural
The history of osteopathy recording introduced patients to the founder of osteopathy, Andrew Taylor Still, and his philosophy of healing.
| Study group | Role | What they receive |
|---|---|---|
| Audio-Guided Mindfulness Intervention | Experimental | Brief, 8-minute, audio-guided mindfulness intervention delivered prior to osteopathic manipulation. Receives: Behavioral: Mindfulness Meditation |
| History of Osteopathy | Active comparator | Brief, 8-minute, audio-guided history of osteopathy delivered prior to osteopathic manipulation. Receives: Behavioral: History of Osteopathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity from immediately before session to immediately after
Pain intensity was measured with individual items rated on a numeric rating scale (0-10). Higher scores indicate more pain.
Measured: Immediately before and after the osteopathic manipulation session (i.e., 1 hour)
Secondary outcomes (4)
Change in Sensation Ratio (Pleasant/Unpleasant) from immediately before session to immediately after
The sensation manikin is a digital human figure silhouette that is overlaid with a grid of 786 "sensation" pixels. Participants identify locations (i.e., grid pixels) on the manikin where they feel both pleasant and unpleasant sensations. Clicking once on any grid pixel turns that location blue, indicating a pleasant sensation. Clicking twice on any grid pixel turns that location red, indicating an unpleasant sensation. Each participant was instructed to color the entire area in which they were currently feeling sensation in their body. A clinically useful sensation ratio score is achieved by dividing the number of pleasant sensation pixels reported by the number of unpleasant sensation pixels reported. Higher scores indicate a larger pleasant sensation to unpleasant sensation ratio.
Measured: Immediately before and after the osteopathic manipulation session (i.e., 1 hour)
Patient Satisfaction
Session satisfaction was measured with an individual item ("I am satisfied with my treatment session.") rated on a numeric rating scale (0-10). Higher scores indicate greater satisfaction.
Measured: Immediately after the osteopathic manipulation session
Change in Mindfulness of the Body from immediately before pre-session audio recording to immediately after
Mindfulness of the body was measured with an individual item ("I felt in contact with my body") from the State Mindfulness Scale (Tanay \& Bernstein, 2013) rated on a numeric rating scale (0-10). Higher scores indicate more mindfulness of the body.
Measured: Immediately before and after the pre-session audio recording (i.e., 10 minutes)
Change in Embodied Safety from immediately before pre-session audio recording to immediately after
Embodied safety was measured with an individual item ("I felt my body was a safe place."), from the Multidimensional Assessment of Interoceptive Awareness (Mehling et al., 2012) rated on a numeric rating scale (0-10). Higher scores indicate greater embodied safety.
Measured: Immediately before and after the pre-session audio recording (i.e., 10 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start25 Mar 2019
- Primary completion16 Sep 2019
- Study completion23 Jun 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 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 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
- NCT04477278
- Sponsor's protocol ID
- IRB_00116896
- Status last verified
- Jul 2020
- First submitted
- 13 Jul 2020
- Last updated
- 20 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be made available to qualified applicants upon receipt of worthy project proposal
Publications
Hanley AW, Wilson Zingg R, Smith B, Zappa M, White S, Davis A, Worts PR, Culjat C, Martorella G. Mindfulness in the Clinic Waiting Room May Decrease Pain: Results from Three Pilot Randomized Controlled Trials. J Integr Complement Med. 2024 Nov;30(11):1082-1091. doi: 10.1089/jicm.2024.0020. Epub 2024 May 17.
PubMed 38757714
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of Mindfulness on Patients' Experience of Osteopathic Manipulation
- ClinicalTrials.gov ID
- NCT04477278
- Acronym / sponsor ID
- IRB_00116896
- Conditions
- Pain, Satisfaction, Patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 16 Sep 2019 (actual)
- Study completion
- 23 Jun 2020 (actual)
- First posted
- 20 Jul 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 is a single site, two-arm, parallel group pilot randomized controlled trial examining the effect of coupling a brief mindfulness-based intervention with an osteopathic manipulation session for pain patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Audio-Guided Mindfulness Intervention | Experimental | Behavioral: Mindfulness MeditationBrief, 8-minute, audio-guided mindfulness intervention delivered prior to osteopathic manipulation. |
| History of Osteopathy | Active comparator | Behavioral: History of OsteopathyBrief, 8-minute, audio-guided history of osteopathy delivered prior to osteopathic manipulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for OMT at the Huntsman Cancer Institute
Key exclusion criteria (1 listed)
- Altered mental status due to delirium, psychosis, or medication sedation as determined by treating clinician.
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 MeditationThe mindfulness meditation recording consisted of instruction in focused attention on breath and body sensations and metacognitive monitoring and acceptance of discursive thoughts, negative emotions, and pain. | Behavioural | Audio-Guided Mindfulness Intervention |
| History of OsteopathyThe history of osteopathy recording introduced patients to the founder of osteopathy, Andrew Taylor Still, and his philosophy of healing. | Behavioural | History of Osteopathy |
Primary outcome
Change in Pain Intensity from immediately before session to immediately after
Time frame: Immediately before and after the osteopathic manipulation session (i.e., 1 hour)
Pain intensity was measured with individual items rated on a numeric rating scale (0-10). Higher scores indicate more pain.
4 secondary outcomes
Change in Sensation Ratio (Pleasant/Unpleasant) from immediately before session to immediately after
Time frame: Immediately before and after the osteopathic manipulation session (i.e., 1 hour)
Patient Satisfaction
Time frame: Immediately after the osteopathic manipulation session
Change in Mindfulness of the Body from immediately before pre-session audio recording to immediately after
Time frame: Immediately before and after the pre-session audio recording (i.e., 10 minutes)
Change in Embodied Safety from immediately before pre-session audio recording to immediately after
Time frame: Immediately before and after the pre-session audio recording (i.e., 10 minutes)
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 20 Jul 2020.
- Derived from this study: PubMed 38757714Hanley AW, Wilson Zingg R, Smith B, Zappa M, White S, Davis A, Worts PR, Culjat C, Martorella G. Mindfulness in the Clinic Waiting Room May Decrease Pain: Results from Three Pilot Randomized Controlled Trials. J Integr Complement Med. 2024 Nov;30(11):1082-1091. doi: 10.1089/jicm.2024.0020. Epub 2024 May 17.
- Individual participant dataSharing planned: Undecided. Data will be made available to qualified applicants upon receipt of worthy project proposal
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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 Meditation and History of Osteopathy in people with Pain and Satisfaction, Patient, 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 1 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 20 Jul 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 Pain Intensity from immediately before session to immediately after (time frame: Immediately before and after the osteopathic manipulation session (i.e., 1 hour)). 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 NCT04477278, 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 20 Jul 2020.