Effects of Mindfulness Meditation on Rhinoplasty Outcomes

NCT03727815 | Withdrawn

• 1 other identifier: IRB00184434
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Nose Deformity

Keywords

mindfulness; meditation; patient satisfaction; rhinoplasty; pain control; quality of life

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Pain as measured by Visual Analog Scale

  Postoperatively at day 2, 2 weeks and 4 weeks

• Pain Control as measured by Prescription Analgesic Use

  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

  Baseline (prior to intervention)

• Change in Anxiety as measured by the State-Trait Anxiety Inventory

  Baseline (prior to intervention), 2 weeks, 4 weeks

• Change in Mindfulness as measured by the Cognitive and Affective Mindfulness Scale-Revised

  Baseline (prior to intervention), 2 weeks, 4 weeks

Study Arms (3)

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.

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.

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.

Interventions

Mindfulness Pain Management Arm OTHER

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 Pain Management Arm

Mindfulness Self Esteem Arm OTHER

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.

Mindfulness Self Esteem Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years of age or older
• Patients who will undergo rhinoplasty
• Patients with access to a smart-phone

You may not qualify if:

• Patients younger than 18 years of age
• Non-English speakers
• Patients without smart-phone access

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (2)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Johns Hopkins - Green Spring Station

Lutherville-Timonium, Maryland, 21093, United States

Location

Related Publications (6)

• 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.

  PMID: 27069249 BACKGROUND

• 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.

  PMID: 20665408 BACKGROUND

• 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.

  PMID: 8193445 BACKGROUND

• 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.

  PMID: 17352896 BACKGROUND

• 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.

  PMID: 28321194 BACKGROUND

• 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.

  PMID: 27398643 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction; Agnosia

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lisa Ishii, MD, MHS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 1, 2018
• Study Start: January 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)