Total Knee ReplacementNCT06118073
Effect of Mindfulness on Pain After Total Knee Arthroplasty
A study testing Headspace and Total Knee Replacement in people with Total Knee Replacement and Post Operative Pain, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
This study will be a prospective randomized controlled trial evaluating the effectiveness of using Headspace before and after undergoing total knee replacement surgery. The purpose of this study will be to determine whether using Headspace will help to improve functional outcome scores, decrease pain, and decrease… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Knee Replacement, Post Operative Pain, Opioid Use
- What is being tested?
- Headspace and Total Knee Replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2023to 30 Nov 2024
- 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 undergoing unilateral primary TKA
- AND
- Patients with MDD who take medication for MDD and/or Patients with GAD who take medication for GAD
- Patients with MDD and/or Patients with GAD who are being treated for those conditions with psychotherapy by a psychologist or psychiatrist
- Patients with an SF-12 Mental Health Score less than 45.6
- Owning a smartphone (Apple or Android) to be able to download the mindfulness application
Who cannot join
- Patients undergoing bilateral TKA
- Patients undergoing revision TKA
- Patients with mental health conditions other than MDD and/or GAD
- Patients currently utilizing a mindfulness application
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: The Effect of Utilizing Mindfulness Perioperatively on Pain, Opioid Consumption, and Functional Outcomes in Patients With Depression and Anxiety Undergoing Total Knee Arthroplasty: A Randomized Clinical Trial
This study will be a prospective randomized controlled trial evaluating the effectiveness of using Headspace before and after undergoing total knee replacement surgery. The purpose of this study will be to determine whether using Headspace will help to improve functional outcome scores, decrease pain, and decrease opioid medication use after total knee replacement in patients with depression and/or anxiety. Headspace is a smartphone-based application that guides individuals through various mindfulness sessions and has been shown to reduce symptoms of depression, anxiety, and pain.
- Conditions
- Total Knee Replacement, Post Operative Pain, Opioid Use
- Being tested
- Headspace, Total Knee Replacement
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeadspaceOther
Headspace is a smartphone-based application that guides individuals through various mindfulness sessions and has been shown to reduce symptoms of depression, anxiety, and pain. Participants will be required to answer questions regarding anxiety levels and pain for 6 weeks after surgery.
Total Knee ReplacementProcedure or surgery
Participant will have total knee replacement surgery
| Study group | Role | What they receive |
|---|---|---|
| Total knee replacement with Headspace | Active comparator | Participants scheduled for primary total knee replacement will be randomized to receive the mindfulness intervention (a smartphone-based mindfulness application). Receives: Other: Headspace; Procedure: Total Knee Replacement |
| Total knee replacement without Headspace | Active comparator | Participants scheduled for primary total knee replacement will not receive the mindfulness intervention. Receives: Procedure: Total Knee Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
postoperative pain will be measured using the Visual Analog Score (VAS)
Measured: 6 weeks
Participant satisfaction #1
Participant satisfaction will be measured using the 12-Item Short Form (SF-12) questionnaire
Measured: 6 weeks
Participant satisfaction #2
Participant satisfaction will be measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS Jr.) questionnaire
Measured: 6 weeks
Participant mental health
mental health will be tracked using the Headspace application after surgery
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start5 Nov 2023 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118073
- Sponsor's protocol ID
- YFILL21P.1017
- Status last verified
- Oct 2023
- First submitted
- 31 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Utilizing Mindfulness Perioperatively on Pain, Opioid Consumption, and Functional Outcomes in Patients With Depression and Anxiety Undergoing Total Knee Arthroplasty: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06118073
- Acronym / sponsor ID
- YFILL21P.1017
- Conditions
- Total Knee Replacement, Post Operative Pain, Opioid Use
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 5 Nov 2023 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 7 Nov 2023 (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 study will be a prospective randomized controlled trial evaluating the effectiveness of using Headspace before and after undergoing total knee replacement surgery. The purpose of this study will be to determine whether using Headspace will help to improve functional outcome scores, decrease pain, and decrease opioid medication use after total knee replacement in patients with depression and/or anxiety. Headspace is a smartphone-based application that guides individuals through various mindfulness sessions and has been shown to reduce symptoms of depression, anxiety, and pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total knee replacement with Headspace | Active comparator | Other: Headspace, Procedure: Total Knee ReplacementParticipants scheduled for primary total knee replacement will be randomized to receive the mindfulness intervention (a smartphone-based mindfulness application). |
| Total knee replacement without Headspace | Active comparator | Procedure: Total Knee ReplacementParticipants scheduled for primary total knee replacement will not receive the mindfulness intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients undergoing unilateral primary TKA
- AND
- Patients with MDD who take medication for MDD and/or Patients with GAD who take medication for GAD
- Patients with MDD and/or Patients with GAD who are being treated for those conditions with psychotherapy by a psychologist or psychiatrist
- Patients with an SF-12 Mental Health Score less than 45.6
Key exclusion criteria (4 listed)
- Patients undergoing bilateral TKA
- Patients undergoing revision TKA
- Patients with mental health conditions other than MDD and/or GAD
- Patients currently utilizing a mindfulness application
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 |
|---|---|---|
| HeadspaceHeadspace is a smartphone-based application that guides individuals through various mindfulness sessions and has been shown to reduce symptoms of depression, anxiety, and pain. Participants will be required to answer questions regarding anxiety levels and pain for 6 weeks after surgery. | Other | Total knee replacement with Headspace |
| Total Knee ReplacementParticipant will have total knee replacement surgery | Procedure or surgery | Total knee replacement with Headspace, Total knee replacement without Headspace |
Primary outcome
Postoperative pain
Time frame: 6 weeks
postoperative pain will be measured using the Visual Analog Score (VAS)
Participant satisfaction #1
Time frame: 6 weeks
Participant satisfaction will be measured using the 12-Item Short Form (SF-12) questionnaire
Participant satisfaction #2
Time frame: 6 weeks
Participant satisfaction will be measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS Jr.) questionnaire
Participant mental health
Time frame: 6 weeks
mental health will be tracked using the Headspace application after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
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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 Headspace and Total Knee Replacement in people with Total Knee Replacement and Post Operative Pain, run by Rothman Institute Orthopaedics 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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 Nov 2023. 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?
Results are not available in the source record.
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?
Postoperative pain (time frame: 6 weeks). The study lists 4 primary outcomes in all. 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 7 Nov 2023.