Effects of Mindfulness Meditation on Rhinoplasty Outcomes

Nose Deformity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03727815
• Other study ID #: IRB00184434
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2021
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Nose Deformity

Intervention

Other:
• Mindfulness 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.
• Mindfulness 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.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Johns Hopkins - Green Spring Station	Lutherville-Timonium	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (6)

Cosmetic Surgery National Data Bank Statistics. Aesthet Surg J. 2016 Apr;36 Suppl 1:1-29. doi: 10.1093/asj/36.Supplement_1.1. — View 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. Review. — View 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. — View 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. — View Citation

Vaughn F, Wichowski H, Bosworth G. Does preoperative anxiety level predict postoperative pain? AORN J. 2007 Mar;85(3):589-604. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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