Nose DeformityNCT03727815
Effects of Mindfulness Meditation on Rhinoplasty Outcomes
A study testing Mindfulness Pain Management Arm and Mindfulness Self Esteem Arm in people with Nose Deformity, run by Johns Hopkins University at 2 sites in United States.
Trial summary
A key factor in determining success of facial plastic plastic surgery is overall patient satisfaction. While a number of patient-reported outcomes tools has been developed, there is still limited research in how physicians can improve patient satisfaction and post-operative outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nose Deformity
- What is being tested?
- Mindfulness Pain Management Arm and Mindfulness Self Esteem Arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2021to 31 Dec 2022
- 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
- Patients 18 years of age or older
- Patients who will undergo rhinoplasty
- Patients with access to a smart-phone
Who cannot join
- Patients younger than 18 years of age
- Non-English speakers
- Patients without smart-phone access
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Johns Hopkins - Green Spring Station
Lutherville-Timonium, Maryland, 21093
About this study
Official title: Mindfulness Meditation to Improve Patient Satisfaction and Post-operative Outcomes in Rhinoplasty Patients: A Randomized Controlled Trial
A key factor in determining success of facial plastic plastic surgery is overall patient satisfaction. While a number of patient-reported outcomes tools has been developed, there is still limited research in how physicians can improve patient satisfaction and post-operative outcomes.
The goal of this study is to investigate the effect of a mindfulness meditation phone application on rhinoplasty outcomes. This study will also explore whether mindfulness meditation is a feasible adjunct to current pharmacological modalities of postoperative pain control as well as its potential impact on patient satisfaction. These questions will be answered using a randomized controlled trial.
Read the detailed description
The field of facial plastic surgery continues to grow as evidenced by the increasing number of services sought by both men and women each year. Among these procedures, rhinoplasty remains one of the most popular surgeries, ranking in the top three most performed cosmetic surgical procedures according to the 2017 Plastic Surgery Statistics Report. A key factor in determining the success of rhinoplasty is overall patient satisfaction. Although many patient-reported outcomes tools have been developed in this space, there is a paucity of research aimed at understanding how physicians can improve patient satisfaction in this patient population. Moreover, strategies to address the psychologic and coping ability for patients undergoing facial plastic surgery have not been investigated. To better provide patient-centered care, physicians should seek to understand the psychosocial impact of perceived nasal deformity and identify patients who may benefit from additional support interventions to complement current rhinoplasty treatment plans.
This is a prospective repeated measures study examining psychosocial status as measured by validated psychometric instruments. The intervention group will participate in mindfulness meditation using a phone application. Assessment of social functioning and quality of life will be conducted using survey instruments.
- Conditions
- Nose Deformity
- Being tested
- Mindfulness Pain Management Arm, Mindfulness Self Esteem Arm
- Keywords
- mindfulness, meditation, patient satisfaction, rhinoplasty, pain control, quality of life
- Medical subject headings
- Patient Satisfaction, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Pain Management ArmOther
Mindfulness Pain Management intervention: patients will be asked to complete a guided mindfulness meditation intervention using a phone application for 2 weeks prior to participant's scheduled procedure and continue with the pain management mindfulness module for 4 weeks postoperatively with periodic survey assessments using validated psychometric tools.
Mindfulness Self Esteem ArmOther
Mindfulness Self Esteem intervention: patients will be asked to complete a guided mindfulness meditation intervention using a phone application for 2 weeks prior to participant's scheduled procedure and continue with the self esteem mindfulness module for 4 weeks postoperatively with periodic survey assessments using validated psychometric tools.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Pain Management Arm | Experimental | Mindfulness meditation intervention - pain management module: patients will be asked to complete a guided mindfulness meditation phone application intervention that was designed to target pain management through mindfulness. Receives: Other: Mindfulness Pain Management Arm |
| Mindfulness Self Esteem Arm | Experimental | Mindfulness meditation intervention - pain management module: patients will be asked to complete a guided mindfulness meditation phone application intervention that was designed to target self esteem through mindfulness. Receives: Other: Mindfulness Self Esteem Arm |
| Non-intervention Arm | No intervention | Patients assigned to the non-intervention arm will not be instructed to use a mindfulness meditation phone application and instead will listen to educational materials. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Satisfaction with patient's Nose as measured by the FACE-Q Satisfaction with Nose Scale
FACE-Q Satisfaction with Nose scale is a 10-item questionnaire with minimum score 10, maximum score 40 assessing patient satisfaction with patient's nose; each item on the questionnaire can be answered between a range of 1 (very dissatisfied) to 4 (very satisfied) with higher scores indicating greater satisfaction with patient's nose
Measured: Baseline (prior to intervention), postoperatively at 2 weeks and 4 weeks
Change in Patient Satisfaction with patient's Nose as measured by the Rhinoplasty Outcome Evaluation scale
Rhinoplasty Outcome Evaluation scale is a 6-item questionnaire with minimum score of 0 and maximum score of 24 assessing patient satisfaction with patient's nose; each item on the questionnaire can be answered between a range of 0 to 4 regarding statements related to patient's nose with higher scores indicating greater satisfaction with patient's nose
Measured: Baseline (prior to intervention), postoperatively at 2 weeks and 4 weeks
Secondary outcomes (7)
Pain as measured by Visual Analog Scale
Pain Visual Analog Scale - single-item question ranging from 0 to 100 with greater numbers indicating more pain experienced after surgery
Measured: Postoperatively at day 2, 2 weeks and 4 weeks
Pain Control as measured by Prescription Analgesic Use
Pain control as measured by prescription analgesic use will be confirmed at the routine postoperative follow-up appointment by prescription pain medication pill-counting to ascertain analgesic usage over the recovery period
Measured: Single measure postoperatively at routine follow-up appointment up to 1 month post procedure
Screen for Body Dysmorphic Disorder as measured by the Body Dysmorphic Disorder Questionnaire
Body Dysmorphic Disorder Questionnaire (BDDQ) - 4-item questionnaire with yes/no responses related to concerns about physical appearance; a "positive" screen per the BDDQ instruction manual suggests the possibility of body dysmorphic disorder but is not diagnostic
Measured: Baseline (prior to intervention)
Change in Anxiety as measured by the State-Trait Anxiety Inventory
State-Trait Anxiety Inventory - 20-item questionnaire with minimum score of 20 and maximum score of 80 (with higher scores meaning more anxiety) intended to measure state anxiety with categorical responses ranging from "never" to "very much so" (4-point Likert scale) in regards to statements about how one feels at the current moment (state) and more generally (trait)
Measured: Baseline (prior to intervention), 2 weeks, 4 weeks
Change in Mindfulness as measured by the Cognitive and Affective Mindfulness Scale-Revised
Cognitive and Affective Mindfulness Scale-Revised - 12-item questionnaire with a minimum score of 12 points and a maximum score of 48 tallied by categorical responses ranging from "rarely/not at all" (1) to "almost always" (4) per item regarding statements about one's experience of mindfulness where higher scores indicate greater mindful qualities
Measured: Baseline (prior to intervention), 2 weeks, 4 weeks
Early Postoperative Symptoms as measured by FACE-Q Recovery Early Symptoms Scale
FACE-Q Recovery Early Symptoms scale - 17-item questionnaire with minimum score 17 and maximum score 68 assessing early symptoms after surgery; each item on the questionnaire can be answered between a range of 1 (not at all) to 4 (extremely) regarding specific symptoms participants may or may not be experiencing after surgery with higher scores indicating greater discomfort, more symptoms, or both
Measured: Postoperatively at day 2
Patient Satisfaction with Doctor as measured by FACE-Q Satisfaction with Doctor Scale
FACE-Q Satisfaction with Doctor scale - 10-item questionnaire with minimum score 10 and maximum score 40 assessing patient satisfaction with patient's doctor; each item on the questionnaire can be answered between a range of 1 (definitely disagree) to 4 (definitely agree) with higher scores indicating greater satisfaction with patient's doctor
Measured: Postoperatively at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start1 Jan 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: Expired IRB application
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Nose DeformityStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Ishii, MD, MHS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727815
- Sponsor's protocol ID
- IRB00184434
- Status last verified
- Mar 2021
- First submitted
- 31 Oct 2018
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cosmetic Surgery National Data Bank Statistics. Aesthet Surg J. 2016 Apr;36 Suppl 1(Suppl 1):1-29. doi: 10.1093/asj/36.Supplement_1.1. No abstract available.
PubMed 27069249Klassen AF, Cano SJ, Scott A, Snell L, Pusic AL. Measuring patient-reported outcomes in facial aesthetic patients: development of the FACE-Q. Facial Plast Surg. 2010 Aug;26(4):303-9. doi: 10.1055/s-0030-1262313. Epub 2010 Jul 27.
PubMed 20665408Perry F, Parker RK, White PF, Clifford PA. Role of psychological factors in postoperative pain control and recovery with patient-controlled analgesia. Clin J Pain. 1994 Mar;10(1):57-63; discussion 82-5. doi: 10.1097/00002508-199403000-00008.
PubMed 8193445Vaughn F, Wichowski H, Bosworth G. Does preoperative anxiety level predict postoperative pain? AORN J. 2007 Mar;85(3):589-604. doi: 10.1016/S0001-2092(07)60130-6.
PubMed 17352896Guendelman S, Medeiros S, Rampes H. Mindfulness and Emotion Regulation: Insights from Neurobiological, Psychological, and Clinical Studies. Front Psychol. 2017 Mar 6;8:220. doi: 10.3389/fpsyg.2017.00220. eCollection 2017.
PubMed 28321194Zeidan 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 27398643
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Meditation to Improve Patient Satisfaction and Post-operative Outcomes in Rhinoplasty Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03727815
- Acronym / sponsor ID
- IRB00184434
- Conditions
- Nose Deformity
- Keywords
- mindfulness, meditation, patient satisfaction, rhinoplasty, pain control, quality of life
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Expired IRB application
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 1 Nov 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.
A key factor in determining success of facial plastic plastic surgery is overall patient satisfaction. While a number of patient-reported outcomes tools has been developed, there is still limited research in how physicians can improve patient satisfaction and post-operative outcomes.
The goal of this study is to investigate the effect of a mindfulness meditation phone application on rhinoplasty outcomes. This study will also explore whether mindfulness meditation is a feasible adjunct to current pharmacological modalities of postoperative pain control as well as its potential impact on patient satisfaction. These questions will be answered using a randomized controlled trial.
Detailed description
The field of facial plastic surgery continues to grow as evidenced by the increasing number of services sought by both men and women each year. Among these procedures, rhinoplasty remains one of the most popular surgeries, ranking in the top three most performed cosmetic surgical procedures according to the 2017 Plastic Surgery Statistics Report. A key factor in determining the success of rhinoplasty is overall patient satisfaction. Although many patient-reported outcomes tools have been developed in this space, there is a paucity of research aimed at understanding how physicians can improve patient satisfaction in this patient population. Moreover, strategies to address the psychologic and coping ability for patients undergoing facial plastic surgery have not been investigated. To better provide patient-centered care, physicians should seek to understand the psychosocial impact of perceived nasal deformity and identify patients who may benefit from additional support interventions to complement current rhinoplasty treatment plans.
This is a prospective repeated measures study examining psychosocial status as measured by validated psychometric instruments. The intervention group will participate in mindfulness meditation using a phone application. Assessment of social functioning and quality of life will be conducted using survey instruments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Pain Management Arm | Experimental | Other: Mindfulness Pain Management ArmMindfulness meditation intervention - pain management module: patients will be asked to complete a guided mindfulness meditation phone application intervention that was designed to target pain management through mindfulness. |
| Mindfulness Self Esteem Arm | Experimental | Other: Mindfulness Self Esteem ArmMindfulness meditation intervention - pain management module: patients will be asked to complete a guided mindfulness meditation phone application intervention that was designed to target self esteem through mindfulness. |
| Non-intervention Arm | No intervention | –Patients assigned to the non-intervention arm will not be instructed to use a mindfulness meditation phone application and instead will listen to educational materials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients 18 years of age or older
- Patients who will undergo rhinoplasty
- Patients with access to a smart-phone
Key exclusion criteria (3 listed)
- Patients younger than 18 years of age
- Non-English speakers
- Patients without smart-phone access
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 Pain Management ArmMindfulness Pain Management intervention: patients will be asked to complete a guided mindfulness meditation intervention using a phone application for 2 weeks prior to participant's scheduled procedure and continue with the pain management mindfulness module for 4 weeks postoperatively with periodic survey assessments using validated psychometric tools. | Other | Mindfulness Pain Management Arm |
| Mindfulness Self Esteem ArmMindfulness Self Esteem intervention: patients will be asked to complete a guided mindfulness meditation intervention using a phone application for 2 weeks prior to participant's scheduled procedure and continue with the self esteem mindfulness module for 4 weeks postoperatively with periodic survey assessments using validated psychometric tools. | Other | Mindfulness Self Esteem Arm |
Primary outcome
Change in Patient Satisfaction with patient's Nose as measured by the FACE-Q Satisfaction with Nose Scale
Time frame: Baseline (prior to intervention), postoperatively at 2 weeks and 4 weeks
FACE-Q Satisfaction with Nose scale is a 10-item questionnaire with minimum score 10, maximum score 40 assessing patient satisfaction with patient's nose; each item on the questionnaire can be answered between a range of 1 (very dissatisfied) to 4 (very satisfied) with higher scores indicating greater satisfaction with patient's nose
Change in Patient Satisfaction with patient's Nose as measured by the Rhinoplasty Outcome Evaluation scale
Time frame: Baseline (prior to intervention), postoperatively at 2 weeks and 4 weeks
Rhinoplasty Outcome Evaluation scale is a 6-item questionnaire with minimum score of 0 and maximum score of 24 assessing patient satisfaction with patient's nose; each item on the questionnaire can be answered between a range of 0 to 4 regarding statements related to patient's nose with higher scores indicating greater satisfaction with patient's nose
7 secondary outcomes
Pain as measured by Visual Analog Scale
Time frame: Postoperatively at day 2, 2 weeks and 4 weeks
Pain Control as measured by Prescription Analgesic Use
Time frame: Single measure postoperatively at routine follow-up appointment up to 1 month post procedure
Screen for Body Dysmorphic Disorder as measured by the Body Dysmorphic Disorder Questionnaire
Time frame: Baseline (prior to intervention)
Change in Anxiety as measured by the State-Trait Anxiety Inventory
Time frame: Baseline (prior to intervention), 2 weeks, 4 weeks
Change in Mindfulness as measured by the Cognitive and Affective Mindfulness Scale-Revised
Time frame: Baseline (prior to intervention), 2 weeks, 4 weeks
Early Postoperative Symptoms as measured by FACE-Q Recovery Early Symptoms Scale
Time frame: Postoperatively at day 2
Patient Satisfaction with Doctor as measured by FACE-Q Satisfaction with Doctor Scale
Time frame: Postoperatively at 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
- Background: PubMed 27069249Cosmetic Surgery National Data Bank Statistics. Aesthet Surg J. 2016 Apr;36 Suppl 1(Suppl 1):1-29. doi: 10.1093/asj/36.Supplement_1.1. No abstract available.
- Background: PubMed 20665408Klassen AF, Cano SJ, Scott A, Snell L, Pusic AL. Measuring patient-reported outcomes in facial aesthetic patients: development of the FACE-Q. Facial Plast Surg. 2010 Aug;26(4):303-9. doi: 10.1055/s-0030-1262313. Epub 2010 Jul 27.
- Background: PubMed 8193445Perry F, Parker RK, White PF, Clifford PA. Role of psychological factors in postoperative pain control and recovery with patient-controlled analgesia. Clin J Pain. 1994 Mar;10(1):57-63; discussion 82-5. doi: 10.1097/00002508-199403000-00008.
- Background: PubMed 17352896Vaughn F, Wichowski H, Bosworth G. Does preoperative anxiety level predict postoperative pain? AORN J. 2007 Mar;85(3):589-604. doi: 10.1016/S0001-2092(07)60130-6.
- Background: PubMed 28321194Guendelman S, Medeiros S, Rampes H. Mindfulness and Emotion Regulation: Insights from Neurobiological, Psychological, and Clinical Studies. Front Psychol. 2017 Mar 6;8:220. doi: 10.3389/fpsyg.2017.00220. eCollection 2017.
- 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.
- 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.
Lisa Ishii, MD, MHS principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Pain Management Arm and Mindfulness Self Esteem Arm in people with Nose Deformity, run by Johns Hopkins University at 2 sites 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 3 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: withdrawn, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was withdrawn before enrolling participants, so there are no results.
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 Patient Satisfaction with patient's Nose as measured by the FACE-Q Satisfaction with Nose Scale (time frame: Baseline (prior to intervention), postoperatively at 2 weeks and 4 weeks). 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 NCT03727815, which also lists 6 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 5 Mar 2021.