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Effects of Mindfulness Meditation on Rhinoplasty Outcomes

Primary Purpose

Nose Deformity

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Pain Management Arm
Mindfulness Self Esteem Arm
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nose Deformity focused on measuring mindfulness, meditation, patient satisfaction, rhinoplasty, pain control, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins Hospital
  • Johns Hopkins - Green Spring Station

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Mindfulness Pain Management Arm

Mindfulness Self Esteem Arm

Non-intervention Arm

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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
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
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)
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
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
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

Full Information

First Posted
October 31, 2018
Last Updated
March 3, 2021
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT03727815
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Expired IRB application
Study Start Date
January 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nose Deformity
Keywords
mindfulness, meditation, patient satisfaction, rhinoplasty, pain control, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Pain Management Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Mindfulness Self Esteem Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-intervention Arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Mindfulness Pain Management Arm
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Mindfulness Self Esteem Arm
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Patient Satisfaction with patient's Nose as measured by the FACE-Q Satisfaction with Nose Scale
Description
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
Time Frame
Baseline (prior to intervention), postoperatively at 2 weeks and 4 weeks
Title
Change in Patient Satisfaction with patient's Nose as measured by the Rhinoplasty Outcome Evaluation scale
Description
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
Time Frame
Baseline (prior to intervention), postoperatively at 2 weeks and 4 weeks
Secondary Outcome Measure Information:
Title
Pain as measured by Visual Analog Scale
Description
Pain Visual Analog Scale - single-item question ranging from 0 to 100 with greater numbers indicating more pain experienced after surgery
Time Frame
Postoperatively at day 2, 2 weeks and 4 weeks
Title
Pain Control as measured by Prescription Analgesic Use
Description
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
Time Frame
Single measure postoperatively at routine follow-up appointment up to 1 month post procedure
Title
Screen for Body Dysmorphic Disorder as measured by the Body Dysmorphic Disorder Questionnaire
Description
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
Time Frame
Baseline (prior to intervention)
Title
Change in Anxiety as measured by the State-Trait Anxiety Inventory
Description
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)
Time Frame
Baseline (prior to intervention), 2 weeks, 4 weeks
Title
Change in Mindfulness as measured by the Cognitive and Affective Mindfulness Scale-Revised
Description
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
Time Frame
Baseline (prior to intervention), 2 weeks, 4 weeks
Title
Early Postoperative Symptoms as measured by FACE-Q Recovery Early Symptoms Scale
Description
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
Time Frame
Postoperatively at day 2
Title
Patient Satisfaction with Doctor as measured by FACE-Q Satisfaction with Doctor Scale
Description
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
Time Frame
Postoperatively at 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Ishii, MD, MHS
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Johns Hopkins - Green Spring Station
City
Lutherville-Timonium
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27069249
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.
Results Reference
background
PubMed Identifier
20665408
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.
Results Reference
background
PubMed Identifier
8193445
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.
Results Reference
background
PubMed Identifier
17352896
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.
Results Reference
background
PubMed Identifier
28321194
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.
Results Reference
background
PubMed Identifier
27398643
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.
Results Reference
background

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Effects of Mindfulness Meditation on Rhinoplasty Outcomes

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