Orthopedic Trauma Surgery PatientsNCT03764839
Digital Behavioral Pain Medicine for Orthopedic Trauma Surgery Patients
A study testing Perioperative Digital Behavioral Pian Medicine "My Surgical Success" in people with Orthopedic Trauma Surgery Patients, run by Stanford University at 1 site in United States.
Trial summary
The primary purpose of this study is to determine the feasibility and preliminary efficacy of a perioperative digital behavioral pain medicine intervention delivered to orthopedic trauma surgery patients (compared to an active control group that receives digital health education). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Trauma Surgery Patients
- What is being tested?
- Perioperative Digital Behavioral Pian Medicine "My Surgical Success"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2018to 5 Apr 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
- Age 18-80 years
- Undergoing a scheduled surgery for orthopedic trauma
- Post-surgery up to 7 days
- English fluency
- Ability and willingness to complete electronic study procedures including questionnaires, assessments, and receipt of treatment.
Who cannot join
- Any conditions causing inability to complete study procedures (e.g. cognitive ability, mental status, medical status) or lack of access to internet and phone that would prevent participation in study procedures - at the discretion of the staff member.
- long-term opioid use prior to surgery
- Known pregnancy
- Ongoing legal action related to pain or disability claim
- Multiple surgeries and/or infections
- Injury is not fracture related or non-trauma surgery
- Documented history of alcohol abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "My Surgical Success": A Randomized Controlled Trial of a Perioperative Digital Behavioral Pain Medicine Treatment Tested in Orthopedic Trauma Patients
The primary purpose of this study is to determine the feasibility and preliminary efficacy of a perioperative digital behavioral pain medicine intervention delivered to orthopedic trauma surgery patients (compared to an active control group that receives digital health education).
Aim 1: Determine feasibility of and satisfaction, and perceived utility of "My Surgical Success"
Read more
Hypothesis 1: For My Surgical Success, the investigators anticipate 50% engagement in the study (feasibility). Of those who complete My Surgical Success, the investigators expect 80% satisfaction ratings, and 80% perceived utility of the information learned.
Aim 2: Determine group differences in time to post-surgical pain and opioid cessation.
Hypothesis 2: "My Surgical Success" participants will evidence quicker time to post-surgical pain and opioid cessation compared to the HE Control Group.
Aim 3: Determine group differences in within-subject pain catastrophizing scores (baseline to post-surgery).
Hypothesis 3: "My Surgical Success" participants evidence greater reduction in pain catastrophizing (measured with the Pain Catastrophizing Scale; PCS) compared to the HE Control group.
Aim 4: Determine group differences in post-surgical psychological correlates (PROMIS Depression, Anxiety, Function, Pain Interference, Sleep Disturbance, Social Isolation, Fatigue, and Pain Intensity).
Hypothesis 4: "My Surgical Success" participants will evidence greater post-surgical function and lower pain related interference compared to the HE Control Group.
The goal of this research is to advance our understanding regarding the feasibility and effectiveness of "My Surgical Success" (a digital, perioperative behavioral pain medicine treatment) and its impact on post-surgical outcomes.
Read the detailed description
Patients are identified by their orthopedic surgeon or study personnel immediately prior to surgery or during their stay on the inpatient post-surgical recovery unit. Beyond recruitment, the entire study is conducted remotely with no in-person contact with study staff. After enrollment, study staff follow-up with patients by phone, text or email (depending on patient preference); informed consent is obtained online.
All participants are asked to provide baseline demographic information, as well as self-reported measures assessing mood, pain, cognitive and emotional responses to pain, catastrophizing, and medications. All measures are administered via a secure, HIPAA compliant, online system (REDCap).
Participants are then randomized to receive one of two digital treatments: a behavioral pain medicine intervention ("My Surgical Success") or to a health education (HE Control). Participants who have been randomized to the HE control group receive online text information about health and nutrition, and are oriented that the information is relevant for improving recovery from surgery. The digital behavioral pain medicine intervention emphasizes treatment content that targets cognitive and emotional regulation in the context of pain. "My Surgical Success" includes three brief psychoeducational video learning modules, a downloadable app with an audio file, and a downloadable PDF Personalized Plan for Success. After participants in the "My Surgical Success" group view the online treatment videos, they complete questions regarding their satisfaction with the video content, perceived usefulness of information, and likelihood to use the skills learned. All participants are tracked twice per week post-surgically to assess pain and opioid use. Data are captured for the duration of the study (12 weeks) or until patients reach opioid cessation (four consecutive surveys indicating zero opioid use). Psychosocial data are collected post-surgically at weeks 4, 8, and 12.
Post-treatment questions:
Participants in the "My Surgical Success" group are asked to rate questions about the about the video content in regards to its understandability, relevance, usefulness, their overall satisfaction, how likely they are to use the information learned.
Following surgery, all participants fill out online brief pain check-ins (2 times per week) to assess pain and medication use. Daily measures continue until the participant reports 4 consecutive reports of zero opiate use. Until reaching this endpoint, pain check-ins are collected for 12 weeks (the duration of the study).
- Conditions
- Orthopedic Trauma Surgery Patients
- Being tested
- Perioperative Digital Behavioral Pian Medicine "My Surgical Success"
- Keywords
- pain, treatment, opioid cessation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perioperative Digital Behavioral Pian Medicine "My Surgical Success"Behavioural
The "My Surgical Success" website include 45 minutes of psychoeducation material developed and delivered by Beth Darnall, PhD. Viewers learn basic skills to improve regulation of pain-related distress. Treatment includes an app and a personalized plan for surgical success.
| Study group | Role | What they receive |
|---|---|---|
| Active Control Group (Digital Health Education) | No intervention | * Demographics survey * Baseline surveys * Participants receive a digital information sheet on nutrition and exercise that are relevant for people recovering from surgery. Participants are encouraged to incorporate healthy lifestyle choices into their daily routines as they recover from surgery Post-surgery: * Pain check-ins (2 times per week) (detailed above) * Patients receive 30 second booster videos at 7, 14, and 21 days after surgery * Follow-up surveys (4, 8, and 12 weeks after surgery) |
| "My Surgical Success" Treatment Group | Experimental | * Demographics survey
* Baseline surveys
* Intervention:
* 45-minute digital behavioral pain medicine intervention "My Surgical Success" that emphasized cognitive and emotional regulation of pain and downregulation of physiologic arousal.
* downloadable app with an audio file
* personalized plan that allows learners to incorporate the treatment information
* Post-video survey (detailed above)
Post-surgery:
* Pain check-ins (2 times per week) (detailed above)
* Follow-up surveys (4, 8, and 12 weeks after surgery) Intervention: Behavioral: Perioperative Digital Behavioral Pain Medicine "My Surgical Success" Receives: Behavioral: Perioperative Digital Behavioral Pian Medicine "My Surgical Success" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant ratings (0-6) for acceptability, satisfaction, usefulness of the information presented, ease of understanding, and likelihood to use skills learning (for the My Surgical Success group only)
Participants complete a single time point rating for 5 items listed above. Ratings occur on a 0-6 point scale (e.g., 0=completely useless and 6=Very useful). Percentages will be reported for each item. A higher score indicates better acceptability, satisfaction, usefulness of the information.
Measured: Immediately post-treatment
Group difference in time to pain and opioid cessation
This will be measured in days until patients achieve opioid cessation. Fewer days indicate better treatment effects
Measured: This is a survival curve with time being a variable of interest. The examination will occur within the 3-month window after surgery.
Secondary outcomes (1)
Group difference in within-subject Pain Catastrophizing Scale (PCS)
PCS measures pain catastrophizing
Measured: Baseline to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start5 Oct 2018
- Primary completion5 Feb 2020
- Study completion5 Apr 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 Orthopedic Trauma Surgery PatientsStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beth Darnall, Stanford University
- Investigators
- Beth Darnall, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764839
- Sponsor's protocol ID
- 42569
- Status last verified
- Oct 2020
- First submitted
- 3 Dec 2018
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ziadni MS, You DS, Keane R, Salazar B, Jaros S, Ram J, Roy A, Tanner N, Salmasi V, Gardner M, Darnall BD. "My Surgical Success": Feasibility and Impact of a Single-Session Digital Behavioral Pain Medicine Intervention on Pain Intensity, Pain Catastrophizing, and Time to Opioid Cessation After Orthopedic Trauma Surgery-A Randomized Trial. Anesth Analg. 2022 Aug 1;135(2):394-405. doi: 10.1213/ANE.0000000000006088. Epub 2022 Jul 5.
PubMed 35696706
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "My Surgical Success": A Randomized Controlled Trial of a Perioperative Digital Behavioral Pain Medicine Treatment Tested in Orthopedic Trauma Patients
- ClinicalTrials.gov ID
- NCT03764839
- Acronym / sponsor ID
- 42569
- Conditions
- Orthopedic Trauma Surgery Patients
- Keywords
- pain, treatment, opioid cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 5 Oct 2018 (actual)
- Primary completion
- 5 Feb 2020 (actual)
- Study completion
- 5 Apr 2020 (actual)
- First posted
- 5 Dec 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 primary purpose of this study is to determine the feasibility and preliminary efficacy of a perioperative digital behavioral pain medicine intervention delivered to orthopedic trauma surgery patients (compared to an active control group that receives digital health education).
Aim 1: Determine feasibility of and satisfaction, and perceived utility of "My Surgical Success"
Hypothesis 1: For My Surgical Success, the investigators anticipate 50% engagement in the study (feasibility). Of those who complete My Surgical Success, the investigators expect 80% satisfaction ratings, and 80% perceived utility of the information learned.
Aim 2: Determine group differences in time to post-surgical pain and opioid cessation.
Hypothesis 2: "My Surgical Success" participants will evidence quicker time to post-surgical pain and opioid cessation compared to the HE Control Group.
Aim 3: Determine group differences in within-subject pain catastrophizing scores (baseline to post-surgery).
Hypothesis 3: "My Surgical Success" participants evidence greater reduction in pain catastrophizing (measured with the Pain Catastrophizing Scale; PCS) compared to the HE Control group.
Aim 4: Determine group differences in post-surgical psychological correlates (PROMIS Depression, Anxiety, Function, Pain Interference, Sleep Disturbance, Social Isolation, Fatigue, and Pain Intensity).
Hypothesis 4: "My Surgical Success" participants will evidence greater post-surgical function and lower pain related interference compared to the HE Control Group.
The goal of this research is to advance our understanding regarding the feasibility and effectiveness of "My Surgical Success" (a digital, perioperative behavioral pain medicine treatment) and its impact on post-surgical outcomes.
Detailed description
Patients are identified by their orthopedic surgeon or study personnel immediately prior to surgery or during their stay on the inpatient post-surgical recovery unit. Beyond recruitment, the entire study is conducted remotely with no in-person contact with study staff. After enrollment, study staff follow-up with patients by phone, text or email (depending on patient preference); informed consent is obtained online.
All participants are asked to provide baseline demographic information, as well as self-reported measures assessing mood, pain, cognitive and emotional responses to pain, catastrophizing, and medications. All measures are administered via a secure, HIPAA compliant, online system (REDCap).
Participants are then randomized to receive one of two digital treatments: a behavioral pain medicine intervention ("My Surgical Success") or to a health education (HE Control). Participants who have been randomized to the HE control group receive online text information about health and nutrition, and are oriented that the information is relevant for improving recovery from surgery. The digital behavioral pain medicine intervention emphasizes treatment content that targets cognitive and emotional regulation in the context of pain. "My Surgical Success" includes three brief psychoeducational video learning modules, a downloadable app with an audio file, and a downloadable PDF Personalized Plan for Success. After participants in the "My Surgical Success" group view the online treatment videos, they complete questions regarding their satisfaction with the video content, perceived usefulness of information, and likelihood to use the skills learned. All participants are tracked twice per week post-surgically to assess pain and opioid use. Data are captured for the duration of the study (12 weeks) or until patients reach opioid cessation (four consecutive surveys indicating zero opioid use). Psychosocial data are collected post-surgically at weeks 4, 8, and 12.
Post-treatment questions:
Participants in the "My Surgical Success" group are asked to rate questions about the about the video content in regards to its understandability, relevance, usefulness, their overall satisfaction, how likely they are to use the information learned.
Following surgery, all participants fill out online brief pain check-ins (2 times per week) to assess pain and medication use. Daily measures continue until the participant reports 4 consecutive reports of zero opiate use. Until reaching this endpoint, pain check-ins are collected for 12 weeks (the duration of the study).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Control Group (Digital Health Education) | No intervention | –* Demographics survey * Baseline surveys * Participants receive a digital information sheet on nutrition and exercise that are relevant for people recovering from surgery. Participants are encouraged to incorporate healthy lifestyle choices into their daily routines as they recover from surgery Post-surgery: * Pain check-ins (2 times per week) (detailed above) * Patients receive 30 second booster videos at 7, 14, and 21 days after surgery * Follow-up surveys (4, 8, and 12 weeks after surgery) |
| "My Surgical Success" Treatment Group | Experimental | Behavioral: Perioperative Digital Behavioral Pian Medicine "My Surgical Success"* Demographics survey * Baseline surveys * Intervention: * 45-minute digital behavioral pain medicine intervention "My Surgical Success" that emphasized cognitive and emotional regulation of pain and downregulation of physiologic arousal. * downloadable app with an audio file * personalized plan that allows learners to incorporate the treatment information * Post-video survey (detailed above) Post-surgery: * Pain check-ins (2 times per week) (detailed above) * Follow-up surveys (4, 8, and 12 weeks after surgery) Intervention: Behavioral: Perioperative Digital Behavioral Pain Medicine "My Surgical Success" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-80 years
- Undergoing a scheduled surgery for orthopedic trauma
- Post-surgery up to 7 days
- English fluency
- Ability and willingness to complete electronic study procedures including questionnaires, assessments, and receipt of treatment.
Key exclusion criteria (7 listed)
- Any conditions causing inability to complete study procedures (e.g. cognitive ability, mental status, medical status) or lack of access to internet and phone that would prevent participation in study procedures - at the discretion of the staff member.
- long-term opioid use prior to surgery
- Known pregnancy
- Ongoing legal action related to pain or disability claim
- Multiple surgeries and/or infections
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 |
|---|---|---|
| Perioperative Digital Behavioral Pian Medicine "My Surgical Success"The "My Surgical Success" website include 45 minutes of psychoeducation material developed and delivered by Beth Darnall, PhD. Viewers learn basic skills to improve regulation of pain-related distress. Treatment includes an app and a personalized plan for surgical success. | Behavioural | "My Surgical Success" Treatment Group |
Primary outcome
Participant ratings (0-6) for acceptability, satisfaction, usefulness of the information presented, ease of understanding, and likelihood to use skills learning (for the My Surgical Success group only)
Time frame: Immediately post-treatment
Participants complete a single time point rating for 5 items listed above. Ratings occur on a 0-6 point scale (e.g., 0=completely useless and 6=Very useful). Percentages will be reported for each item. A higher score indicates better acceptability, satisfaction, usefulness of the information.
Group difference in time to pain and opioid cessation
Time frame: This is a survival curve with time being a variable of interest. The examination will occur within the 3-month window after surgery.
This will be measured in days until patients achieve opioid cessation. Fewer days indicate better treatment effects
1 secondary outcome
Group difference in within-subject Pain Catastrophizing Scale (PCS)
Time frame: Baseline to 1 month
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 26 Oct 2020.
- Derived from this study: PubMed 35696706Ziadni MS, You DS, Keane R, Salazar B, Jaros S, Ram J, Roy A, Tanner N, Salmasi V, Gardner M, Darnall BD. "My Surgical Success": Feasibility and Impact of a Single-Session Digital Behavioral Pain Medicine Intervention on Pain Intensity, Pain Catastrophizing, and Time to Opioid Cessation After Orthopedic Trauma Surgery-A Randomized Trial. Anesth Analg. 2022 Aug 1;135(2):394-405. doi: 10.1213/ANE.0000000000006088. Epub 2022 Jul 5.
- 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.
Beth Darnall, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perioperative Digital Behavioral Pian Medicine "My Surgical Success" in people with Orthopedic Trauma Surgery Patients, run by Stanford University 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 5 inclusion and 7 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 26 Oct 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?
Participant ratings (0-6) for acceptability, satisfaction, usefulness of the information presented, ease of understanding, and likelihood to use skills learning (for the My Surgical Success group only) (time frame: Immediately post-treatment). 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 NCT03764839, 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 26 Oct 2020.