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Effects of Mindfulness Meditation on Rhinoplasty Outcomes

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ClinicalTrials.gov Identifier: NCT03727815
Recruitment Status : Not yet recruiting
First Posted : November 1, 2018
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.


Condition or disease Intervention/treatment Phase
Nose Deformity Other: Mindfulness Pain Management Arm Other: Mindfulness Self Esteem Arm Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness Meditation to Improve Patient Satisfaction and Post-operative Outcomes in Rhinoplasty Patients: A Randomized Controlled Trial
Estimated Study Start Date : December 31, 2019
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mindfulness Pain Management Arm
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 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.

Experimental: Mindfulness Self Esteem Arm
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
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.

No Intervention: Non-intervention Arm
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.



Primary Outcome Measures :
  1. Change in Patient Satisfaction with patient's Nose as measured by the FACE-Q Satisfaction with Nose Scale [ Time Frame: 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

  2. Change in Patient Satisfaction with patient's Nose as measured by the Rhinoplasty Outcome Evaluation scale [ Time Frame: 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 Outcome Measures :
  1. Pain as measured by Visual Analog Scale [ Time Frame: 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

  2. Pain Control as measured by Prescription Analgesic Use [ Time Frame: 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

  3. Screen for Body Dysmorphic Disorder as measured by the Body Dysmorphic Disorder Questionnaire [ Time Frame: 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

  4. Change in Anxiety as measured by the State-Trait Anxiety Inventory [ Time Frame: 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)

  5. Change in Mindfulness as measured by the Cognitive and Affective Mindfulness Scale-Revised [ Time Frame: 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

  6. Early Postoperative Symptoms as measured by FACE-Q Recovery Early Symptoms Scale [ Time Frame: 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

  7. Patient Satisfaction with Doctor as measured by FACE-Q Satisfaction with Doctor Scale [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727815


Contacts
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Contact: David Liao 917-353-6216 dliao5@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Johns Hopkins - Green Spring Station
Lutherville-Timonium, Maryland, United States, 21093
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Lisa Ishii, MD, MHS Johns Hopkins University

Publications:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03727815     History of Changes
Other Study ID Numbers: IRB00184434
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
mindfulness
meditation
patient satisfaction
rhinoplasty
pain control
quality of life
Additional relevant MeSH terms:
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Congenital Abnormalities