Nose Deformity
Conditions
Keywords
mindfulness, meditation, patient satisfaction, rhinoplasty, pain control, quality of life
Brief 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. 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.
Interventions
OTHERMindfulness Pain Management Arm
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.
OTHERMindfulness Self Esteem Arm
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.
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Satisfaction with patient's Nose as measured by the FACE-Q Satisfaction with Nose Scale | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Screen for Body Dysmorphic Disorder as measured by the Body Dysmorphic Disorder Questionnaire | Baseline (prior to intervention) | 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 |
| Change in Anxiety as measured by the State-Trait Anxiety Inventory | Baseline (prior to intervention), 2 weeks, 4 weeks | 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) |
| Pain as measured by Visual Analog Scale | Postoperatively at day 2, 2 weeks and 4 weeks | Pain Visual Analog Scale - single-item question ranging from 0 to 100 with greater numbers indicating more pain experienced after surgery |
| Early Postoperative Symptoms as measured by FACE-Q Recovery Early Symptoms Scale | Postoperatively at day 2 | 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 |
| Patient Satisfaction with Doctor as measured by FACE-Q Satisfaction with Doctor Scale | Postoperatively at 4 weeks | 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 |
| Change in Mindfulness as measured by the Cognitive and Affective Mindfulness Scale-Revised | Baseline (prior to intervention), 2 weeks, 4 weeks | 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 |
| Pain Control as measured by Prescription Analgesic Use | Single measure postoperatively at routine follow-up appointment up to 1 month post procedure | 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 |
Countries
United States
Outcome results
None listed