Clinical trial NCT03727815: Effects of Mindfulness Meditation on Rhinoplasty Outcomes
Official title: Mindfulness Meditation to Improve Patient Satisfaction and Post-operative Outcomes in Rhinoplasty Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Nose Deformity
Keywords: mindfulness
meditation
patient satisfaction
rhinoplasty
pain control
quality of life
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-11-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Patient Satisfaction with patient's Nose as measured by the FACE-Q Satisfaction with Nose Scale
timeFrame: Baseline (prior to intervention), postoperatively at 2 weeks and 4 weeks
measure: Change in Patient Satisfaction with patient's Nose as measured by the Rhinoplasty Outcome Evaluation scale
timeFrame: Baseline (prior to intervention), postoperatively at 2 weeks and 4 weeks
Secondary outcomes:
measure: Pain as measured by Visual Analog Scale
timeFrame: Postoperatively at day 2, 2 weeks and 4 weeks
measure: Pain Control as measured by Prescription Analgesic Use
timeFrame: Single measure postoperatively at routine follow-up appointment up to 1 month post procedure
measure: Screen for Body Dysmorphic Disorder as measured by the Body Dysmorphic Disorder Questionnaire
timeFrame: Baseline (prior to intervention)
measure: Change in Anxiety as measured by the State-Trait Anxiety Inventory
timeFrame: Baseline (prior to intervention), 2 weeks, 4 weeks
measure: Change in Mindfulness as measured by the Cognitive and Affective Mindfulness Scale-Revised
timeFrame: Baseline (prior to intervention), 2 weeks, 4 weeks
measure: Early Postoperative Symptoms as measured by FACE-Q Recovery Early Symptoms Scale
timeFrame: Postoperatively at day 2
measure: Patient Satisfaction with Doctor as measured by FACE-Q Satisfaction with Doctor Scale
timeFrame: Postoperatively at 4 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Lutherville-Timonium
country: United States
facility: Johns Hopkins - Green Spring Station
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Lisa Ishii, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Klassen 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.
citation: Perry 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.
citation: Vaughn 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.
citation: Guendelman 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.
citation: Zeidan 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.