Pain, PostoperativeNCT05157490
Preoperative Mindfulness: Minimally Invasive Hysterectomy
A study testing Mindfulness training in people with Pain, Postoperative, run by Montefiore Medical Center at 1 site in United States.
Trial summary
This is a randomized control trial investigating the effects of a preoperative mindfulness intervention on postoperative pain, quality of recovery and stress scores in women undergoing minimally invasive hysterectomy. The mindfulness intervention will be delivered via the application Headspace™. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Mindfulness training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2023to 24 Oct 2025
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo minimally invasive hysterectomy
- Fluency in English and/or Spanish
- Access to a device capable of running the Headspace application (smart phone or computer)
Who cannot join
- Minors
- Hearing impairment
- Inability to access Headspace app
- Inability to complete baseline or postoperative surveys: Perceived Stress Scale-10 (PSS-10) or Quality of Recovery-15 (QOR-15) surveys
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center-Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: Preoperative Mindfulness Training for Minimally Invasive Hysterectomy
This is a randomized control trial investigating the effects of a preoperative mindfulness intervention on postoperative pain, quality of recovery and stress scores in women undergoing minimally invasive hysterectomy. The mindfulness intervention will be delivered via the application Headspace™. The study team hypothesizes that mindfulness practiced in the form of meditation delivered via an internet application will lead to reduced pain scores on postoperative day 1.
Read the detailed description
Pain is a subjective experience influenced by both physical and psychosocial factors.
Postoperative pain can be difficult to treat, frequently leading to underassessment, undertreatment, decreased patient satisfaction and decreased quality of life. Historically efforts have focused on pharmacologic treatments, with opioids commonly being used to manage acute postoperative pain. Overprescribing of opioids remains prevalent despite now well studied adverse outcomes including increased risk for longer length of inpatient stay, future hospitalizations, and risk of dependence. Particularly in the setting of the opioid epidemic, non-pharmacologic interventions for pain management have become more attractive to practitioners and patients alike.
Psychosocial aspects of pain including catastrophizing, fear, and negative emotions can be targeted by interventions such as mindfulness training, hypnotic suggestion, and psychoeducation. Mindfulness meditations have been shown to engage mechanisms distinct from placebo by attenuating the subjective experience of pain and may be particularly effective when used in combination with pharmacologic analgesia. Mindfulness based interventions have been better studied in the setting of chronic pain with limited data available in the setting of acute pain. In the gynecology literature, dispositional mindfulness was demonstrated to have a positive effect on postoperative pain scores, but no studies to date have examined the effect of pre-procedure mindfulness interventions specifically on postoperative pain. In addition, those studies which exist have focused on populations that are majority non-Hispanic white and have utilized sessions conducted with trained social workers. The investigator team believes there is a unique opportunity to investigate the effects of mindfulness interventions delivered via a systematically reviewed internet application in an urban academic tertiary care center on postoperative pain. This is the first study to examine the effect of preoperative mindfulness training on the recovery process, pain and stress associated with hysterectomy and could represent a low cost, low risk intervention in order to improve perioperative well-being.
- Conditions
- Pain, Postoperative
- Being tested
- Mindfulness training
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness trainingBehavioural
Guided meditations in the preoperative time period, at least 3 sessions per week, leading up to surgery
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness training | Experimental | Completion of guided meditations in the preoperative time period, at least 3 sessions per week, leading up to surgery Receives: Behavioral: Mindfulness training |
| Control | No intervention | Standard pre- and postoperative medications will be given to the patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Pain scores will be measured on postoperative Day 1 (POD1) using the validated Numeric Pain Rating Scale. The Numeric Pain Rating scale is an 11-point pain intensity rating scale (PI-NRS) ranging from 1-10, where 0 = "No pain" and 10 = "Worst possible pain" such that higher scores are associated with greater pain severity/intensity. Scores will be summarized by study arm using basic descriptive statistics.
Measured: 1 day postoperatively
Secondary outcomes (6)
Pain score
Pain scores will also be measured on postoperative Day 7 (POD7) using the validated Numeric Pain Rating Scale. The Numeric Pain Rating scale is an 11-point pain intensity rating scale (PI-NRS) ranging from 1-10, where 0 = "No pain" and 10 = "Worst possible pain" such that higher scores are associated with greater pain severity/intensity. Scores will be summarized by study arm using basic descriptive statistics.
Measured: 7 days postoperatively
Quality of Recovery
Quality of Recovery will be assessed on POD1 and POD7 using the Quality of Recovery-15 (QoR-15) scale. The QoR-15 is a patient-reported tool measuring post-surgical recovery, using 15 questions across domains such as pain, physical comfort, emotional state, physical independence, and psychological support over the prior 24-hour period. Each question on the QoR-15 is rated using an 11-point numerical rating scale ranging from 0 = "None of the time" to 15 = "All of the time" yielding an overall possible scoring range of 0-150. The final five items are reverse coded. Higher scores are associated with better quality of recovery. Scores will be summarized by study arm using basic descriptive statistics.
Measured: 1 day and 7 days postoperatively (POD1 and POD7)
Perceived Stress
Perceived stress will be assessed on POD1 and POD7 using the 10-item Perceived Stress Scoring (PSS-10) scale. The PSS-10 presents patients with 10 questions and asks them to rate how often they felt a certain way regarding specific feelings and thoughts over the prior month. Responses are rated using a 4-point Likert scale wherein 0 = "Never," 1 = "Almost never," 2 = "Sometimes," 3 = "Often," and 4 = "Very often" yielding a total overall score of 0-40. Four of the questions/items are reverse coded and their scores are reversed (i.e., 0=4, 1=3, 2=2, 3=1, 4=0). Higher scores are associated with increased feelings of perceived stress and helplessness. Scores will be summarized by study arm using basic descriptive statistics.
Measured: 1 day and 7 days postoperatively (POD1 and POD7)
Opioid consumption
The number of opioid/analgesic tablets used postoperatively will be determined by telephone surveys administered on POD1 and POD7. Results will be summarized by study arm.
Measured: 1 day and 7 days postoperatively (POD1 and POD7)
Non-analgesic opioid consumption
The number of non-analgesic opioid tablets used postoperatively will be determined by telephone surveys administered on POD1 and POD7. Results will be summarized by study arm.
Measured: 1 day and 7 days postoperatively (POD1 and POD7)
Effect of Meditation Session
The effect of meditation sessions will be assessed by dose response based on the number of meditation sessions OR the number of minutes of meditation performed, on pain and quality of recovery scores.
Measured: Up to 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start20 Jun 2023
- Primary completion18 Oct 2025
- Study completion24 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe 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
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Howard University, Headspace Meditation Limited
- Responsible party
- Sponsor
- Investigators
- Kari M Plewniak, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157490
- Sponsor's protocol ID
- 2020-12609
- Status last verified
- Jan 2026
- First submitted
- 2 Dec 2021
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.
PubMed 26509324Lin RJ, Reid MC, Liu LL, Chused AE, Evans AT. The Barriers to High-Quality Inpatient Pain Management: A Qualitative Study. Am J Hosp Palliat Care. 2015 Sep;32(6):594-9. doi: 10.1177/1049909114530491. Epub 2014 Apr 11.
PubMed 24728202Burden M, Keniston A, Wallace MA, Busse JW, Casademont J, Chadaga SR, Chandrasekaran S, Cicardi M, Cunningham JM, Filella D, Hoody D, Hilden D, Hsieh MJ, Lee YS, Melley DD, Munoa A, Perego F, Shu CC, Sohn CH, Spence J, Thurman L, Towns CR, You J, Zocchi L, Albert RK. Opioid Utilization and Perception of Pain Control in Hospitalized Patients: A Cross-Sectional Study of 11 Sites in 8 Countries. J Hosp Med. 2019 Dec 1;14(12):737-745. doi: 10.12788/jhm.3256. Epub 2019 Jul 24.
PubMed 31339840Liang Y, Turner BJ. National cohort study of opioid analgesic dose and risk of future hospitalization. J Hosp Med. 2015 Jul;10(7):425-31. doi: 10.1002/jhm.2350. Epub 2015 Mar 16.
PubMed 25772626Houry D, Baldwin G. Announcing the CDC guideline for prescribing opioids for chronic pain. J Safety Res. 2016 Jun;57:83-4. doi: 10.1016/j.jsr.2016.03.007. Epub 2016 Apr 16.
PubMed 27178083Apkarian AV, Bushnell MC, Treede RD, Zubieta JK. Human brain mechanisms of pain perception and regulation in health and disease. Eur J Pain. 2005 Aug;9(4):463-84. doi: 10.1016/j.ejpain.2004.11.001. Epub 2005 Jan 21.
PubMed 15979027Wiech K, Tracey I. The influence of negative emotions on pain: behavioral effects and neural mechanisms. Neuroimage. 2009 Sep;47(3):987-94. doi: 10.1016/j.neuroimage.2009.05.059. Epub 2009 May 28.
PubMed 19481610Zeidan F, Vago DR. Mindfulness meditation-based pain relief: a mechanistic account. Ann N Y Acad Sci. 2016 Jun;1373(1):114-27. doi: 10.1111/nyas.13153.
PubMed 27398643Cherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ, Hansen KE, Turner JA. Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1240-9. doi: 10.1001/jama.2016.2323.
PubMed 27002445Garland EL, Baker AK, Larsen P, Riquino MR, Priddy SE, Thomas E, Hanley AW, Galbraith P, Wanner N, Nakamura Y. Randomized Controlled Trial of Brief Mindfulness Training and Hypnotic Suggestion for Acute Pain Relief in the Hospital Setting. J Gen Intern Med. 2017 Oct;32(10):1106-1113. doi: 10.1007/s11606-017-4116-9. Epub 2017 Jul 12.
PubMed 28702870Hilton L, Hempel S, Ewing BA, Apaydin E, Xenakis L, Newberry S, Colaiaco B, Maher AR, Shanman RM, Sorbero ME, Maglione MA. Mindfulness Meditation for Chronic Pain: Systematic Review and Meta-analysis. Ann Behav Med. 2017 Apr;51(2):199-213. doi: 10.1007/s12160-016-9844-2.
PubMed 27658913McClintock AS, McCarrick SM, Garland EL, Zeidan F, Zgierska AE. Brief Mindfulness-Based Interventions for Acute and Chronic Pain: A Systematic Review. J Altern Complement Med. 2019 Mar;25(3):265-278. doi: 10.1089/acm.2018.0351. Epub 2018 Dec 5.
PubMed 30523705Weston E, Raker C, Huang D, Parker A, Robison K, Mathews C. The Association Between Mindfulness and Postoperative Pain: A Prospective Cohort Study of Gynecologic Oncology Patients Undergoing Minimally Invasive Hysterectomy. J Minim Invasive Gynecol. 2020 Jul-Aug;27(5):1119-1126.e2. doi: 10.1016/j.jmig.2019.08.021. Epub 2019 Aug 23.
PubMed 31449907Mani M, Kavanagh DJ, Hides L, Stoyanov SR. Review and Evaluation of Mindfulness-Based iPhone Apps. JMIR Mhealth Uhealth. 2015 Aug 19;3(3):e82. doi: 10.2196/mhealth.4328.
PubMed 26290327Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.
PubMed 11690728
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Mindfulness Training for Minimally Invasive Hysterectomy
- ClinicalTrials.gov ID
- NCT05157490
- Acronym / sponsor ID
- 2020-12609
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Howard University, Headspace Meditation Limited
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 18 Oct 2025 (actual)
- Study completion
- 24 Oct 2025 (actual)
- First posted
- 15 Dec 2021 (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 randomized control trial investigating the effects of a preoperative mindfulness intervention on postoperative pain, quality of recovery and stress scores in women undergoing minimally invasive hysterectomy. The mindfulness intervention will be delivered via the application Headspace™. The study team hypothesizes that mindfulness practiced in the form of meditation delivered via an internet application will lead to reduced pain scores on postoperative day 1.
Detailed description
Pain is a subjective experience influenced by both physical and psychosocial factors.
Postoperative pain can be difficult to treat, frequently leading to underassessment, undertreatment, decreased patient satisfaction and decreased quality of life. Historically efforts have focused on pharmacologic treatments, with opioids commonly being used to manage acute postoperative pain. Overprescribing of opioids remains prevalent despite now well studied adverse outcomes including increased risk for longer length of inpatient stay, future hospitalizations, and risk of dependence. Particularly in the setting of the opioid epidemic, non-pharmacologic interventions for pain management have become more attractive to practitioners and patients alike.
Psychosocial aspects of pain including catastrophizing, fear, and negative emotions can be targeted by interventions such as mindfulness training, hypnotic suggestion, and psychoeducation. Mindfulness meditations have been shown to engage mechanisms distinct from placebo by attenuating the subjective experience of pain and may be particularly effective when used in combination with pharmacologic analgesia. Mindfulness based interventions have been better studied in the setting of chronic pain with limited data available in the setting of acute pain. In the gynecology literature, dispositional mindfulness was demonstrated to have a positive effect on postoperative pain scores, but no studies to date have examined the effect of pre-procedure mindfulness interventions specifically on postoperative pain. In addition, those studies which exist have focused on populations that are majority non-Hispanic white and have utilized sessions conducted with trained social workers. The investigator team believes there is a unique opportunity to investigate the effects of mindfulness interventions delivered via a systematically reviewed internet application in an urban academic tertiary care center on postoperative pain. This is the first study to examine the effect of preoperative mindfulness training on the recovery process, pain and stress associated with hysterectomy and could represent a low cost, low risk intervention in order to improve perioperative well-being.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness training | Experimental | Behavioral: Mindfulness trainingCompletion of guided meditations in the preoperative time period, at least 3 sessions per week, leading up to surgery |
| Control | No intervention | –Standard pre- and postoperative medications will be given to the patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled to undergo minimally invasive hysterectomy
- Fluency in English and/or Spanish
- Access to a device capable of running the Headspace application (smart phone or computer)
Key exclusion criteria (4 listed)
- Minors
- Hearing impairment
- Inability to access Headspace app
- Inability to complete baseline or postoperative surveys: Perceived Stress Scale-10 (PSS-10) or Quality of Recovery-15 (QOR-15) surveys
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 trainingGuided meditations in the preoperative time period, at least 3 sessions per week, leading up to surgery | Behavioural | Mindfulness training |
Primary outcome
Pain score
Time frame: 1 day postoperatively
Pain scores will be measured on postoperative Day 1 (POD1) using the validated Numeric Pain Rating Scale. The Numeric Pain Rating scale is an 11-point pain intensity rating scale (PI-NRS) ranging from 1-10, where 0 = "No pain" and 10 = "Worst possible pain" such that higher scores are associated with greater pain severity/intensity. Scores will be summarized by study arm using basic descriptive statistics.
6 secondary outcomes
Pain score
Time frame: 7 days postoperatively
Quality of Recovery
Time frame: 1 day and 7 days postoperatively (POD1 and POD7)
Perceived Stress
Time frame: 1 day and 7 days postoperatively (POD1 and POD7)
Opioid consumption
Time frame: 1 day and 7 days postoperatively (POD1 and POD7)
Non-analgesic opioid consumption
Time frame: 1 day and 7 days postoperatively (POD1 and POD7)
Effect of Meditation Session
Time frame: Up to 7 days postoperatively
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 23 Jan 2026.
- Background: PubMed 26509324Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.
- Background: PubMed 24728202Lin RJ, Reid MC, Liu LL, Chused AE, Evans AT. The Barriers to High-Quality Inpatient Pain Management: A Qualitative Study. Am J Hosp Palliat Care. 2015 Sep;32(6):594-9. doi: 10.1177/1049909114530491. Epub 2014 Apr 11.
- Background: PubMed 31339840Burden M, Keniston A, Wallace MA, Busse JW, Casademont J, Chadaga SR, Chandrasekaran S, Cicardi M, Cunningham JM, Filella D, Hoody D, Hilden D, Hsieh MJ, Lee YS, Melley DD, Munoa A, Perego F, Shu CC, Sohn CH, Spence J, Thurman L, Towns CR, You J, Zocchi L, Albert RK. Opioid Utilization and Perception of Pain Control in Hospitalized Patients: A Cross-Sectional Study of 11 Sites in 8 Countries. J Hosp Med. 2019 Dec 1;14(12):737-745. doi: 10.12788/jhm.3256. Epub 2019 Jul 24.
- Background: PubMed 25772626Liang Y, Turner BJ. National cohort study of opioid analgesic dose and risk of future hospitalization. J Hosp Med. 2015 Jul;10(7):425-31. doi: 10.1002/jhm.2350. Epub 2015 Mar 16.
- Background: PubMed 27178083Houry D, Baldwin G. Announcing the CDC guideline for prescribing opioids for chronic pain. J Safety Res. 2016 Jun;57:83-4. doi: 10.1016/j.jsr.2016.03.007. Epub 2016 Apr 16.
- Background: PubMed 15979027Apkarian AV, Bushnell MC, Treede RD, Zubieta JK. Human brain mechanisms of pain perception and regulation in health and disease. Eur J Pain. 2005 Aug;9(4):463-84. doi: 10.1016/j.ejpain.2004.11.001. Epub 2005 Jan 21.
- Background: PubMed 19481610Wiech K, Tracey I. The influence of negative emotions on pain: behavioral effects and neural mechanisms. Neuroimage. 2009 Sep;47(3):987-94. doi: 10.1016/j.neuroimage.2009.05.059. Epub 2009 May 28.
- Background: PubMed 27398643Zeidan F, Vago DR. Mindfulness meditation-based pain relief: a mechanistic account. Ann N Y Acad Sci. 2016 Jun;1373(1):114-27. doi: 10.1111/nyas.13153.
- Background: PubMed 27002445Cherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ, Hansen KE, Turner JA. Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1240-9. doi: 10.1001/jama.2016.2323.
- Background: PubMed 28702870Garland EL, Baker AK, Larsen P, Riquino MR, Priddy SE, Thomas E, Hanley AW, Galbraith P, Wanner N, Nakamura Y. Randomized Controlled Trial of Brief Mindfulness Training and Hypnotic Suggestion for Acute Pain Relief in the Hospital Setting. J Gen Intern Med. 2017 Oct;32(10):1106-1113. doi: 10.1007/s11606-017-4116-9. Epub 2017 Jul 12.
- Background: PubMed 27658913Hilton L, Hempel S, Ewing BA, Apaydin E, Xenakis L, Newberry S, Colaiaco B, Maher AR, Shanman RM, Sorbero ME, Maglione MA. Mindfulness Meditation for Chronic Pain: Systematic Review and Meta-analysis. Ann Behav Med. 2017 Apr;51(2):199-213. doi: 10.1007/s12160-016-9844-2.
- Background: PubMed 30523705McClintock AS, McCarrick SM, Garland EL, Zeidan F, Zgierska AE. Brief Mindfulness-Based Interventions for Acute and Chronic Pain: A Systematic Review. J Altern Complement Med. 2019 Mar;25(3):265-278. doi: 10.1089/acm.2018.0351. Epub 2018 Dec 5.
- Journal of Applied Social Psychology, 42, 1320-1334. This article provides Normative Data for the PSS-10 from large 2006 and 2009 probability samples of the U.S.Link provided by the sponsor.
- 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.
Kari M Plewniak, MD principal investigator
Montefiore Medical Center
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 training in people with Pain, Postoperative, run by Montefiore Medical Center 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 3 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: finished, as of the sponsor's last update on 23 Jan 2026. 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 score (time frame: 1 day postoperatively). 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 NCT05157490, which also lists 19 linked publications.
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 23 Jan 2026.