Effects of Mindfulness Meditation on Rhinoplasty Outcomes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mindfulness Meditation to Improve Patient Satisfaction and Post-operative Outcomes in Rhinoplasty Patients: A Randomized Controlled Trial

Conditions
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Nose Deformity

Intervention / Treatment
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* Other: Mindfulness Pain Management Arm
* Other: Mindfulness Self Esteem Arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years of age or older Patients who will undergo rhinoplasty Patients with access to a smart-phone Exclusion Criteria: Patients younger than 18 years of age Non-English speakers Patients without smart-phone access

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Pain Management Arm<br>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. | Other: Mindfulness Pain Management Arm<br>* 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.<br>|
| Experimental: Mindfulness Self Esteem Arm<br>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. | Other: Mindfulness Self Esteem Arm<br>* 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.<br>|
| No Intervention: Non-intervention Arm<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Baseline (prior to intervention), postoperatively at 2 weeks and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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) | 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 | 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 | 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 | Postoperatively at 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mindfulness, meditation, patient satisfaction, rhinoplasty, pain control, quality of life