Relaxing Environment to Lower Anxiety During Onabotulinum Toxin Chemodenervation of the Bladder

NCT06319898 | Completed Results

• 1 other identifier: IRB00110787
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

Chemodenervation of the bladder with onabotulinum toxin A is an effective treatment option for patients with refractory urgency urinary incontinence (UUI). It is often performed as an office-based procedure under local anesthesia. Alternatively, it can be performed in the operating room under general anesthesia. The ability to receive intra-detrusor chemodenervation in the office allows patients to avoid the risks associated with general anesthesia and is significantly more cost effective. The procedure, however, is painful and can be anxiety provoking for patients; especially given that patients typically return every six to nine months for repeat injections. Relaxation and distraction techniques are one way to ease patients' anxiety before an office-based procedure. While we do not know exactly how anxiety provoking office bladder chemodenervation is for patients, we do know that anxiety disorders are highly prevalent in women with overactive bladder as a population. The purpose of this study is to investigate whether women with Urge urinary incontinence (UUI) who receive office intra-detrusor chemodenervation injections performed in a relaxing environment of lavender aromatherapy, calming music, dim lighting, and modest positioning (Relaxing Environment Package) will have decreased anxiety and pain as well as increased post-procedure satisfaction compared to patients who receive chemodenervation in a typical office environment. Also investigate whether exposure to the relaxing environment impacts the well-being of staff involved in these procedures. This study design is a randomized control trial. Women scheduled for office intra-detrusor chemodenervation at Atrium Health women's Care Urogynecology \& Pelvic Surgery - Mercy clinic will be invited to participate. Participants will be randomized to the relaxing environment package or the placebo group after informed consent is obtained and immediately before undergoing intra-detrusor chemodenervation. The participants will complete the pre-procedure visual analog scale (VAS) for anxiety and a VAS for pain at baseline.

Conditions

Anxiety; Pain; Burnout, Professional

Keywords

aromatherapy; bladder botox; anxiety; lavender

Outcome Measures

Primary Outcomes (1)

• Mean Change in Visual Analog Scale (VAS) Anxiety Scores

  The VAS for anxiety is a validated scale that ranges from 0-100mm. 0mm is equivalent to "no anxiety" and is located on the left. 100mm is equivalent to "extremely anxious" and is located on the right. The minimum clinically important difference for VAS anxiety is a change of 12mm on a 100mm scale.

  Baseline to Minute 30

Secondary Outcomes (3)

• Mean Change in Visual Analog Scale (VAS) Pain During the Chemodenervation Procedure

  Baseline to post-procedure up to 2 hours

• Procedure Staff Burnout Scores - Burnout Battery Visual Analog Scale for Healthcare Worker Burnout

  Baseline to post-procedure up to 2 hours

• Patient Satisfaction With Their Procedure Experience Scores

  post procedure up to 2 hours

Study Arms (4)

Lavender aromatherapy sticker

EXPERIMENTAL

Lavender aromatherapy sticker on patient Calming music from Sirius station 68 (Spa) playing via overhead speakers Overhead lights off, two lanterns lit to provide dim lighting Avoid stirrup use

Behavioral: Lavender aromatherapy sticker

Control - no Intervention

NO INTERVENTION

Non-aromatic (placebo) sticker on patient No music playing Overhead lights on Stirrups used

Procedure Team Intervention - relaxing environment

EXPERIMENTAL

lavender aromatherapy, calming music, and dim lighting - Members of the procedure team - participation in this research will involve a 3 question initial questionnaire survey to assess demographics and prior experience with aromatherapy and pre- and post-clinic survey on the days you participate in bladder Botox procedures.

Behavioral: Lavender aromatherapy sticker

Procedure Team Control - no Intervention

NO INTERVENTION

Members of the procedure team - participation in this research will involve a 3 question initial questionnaire survey to assess demographics and prior experience with aromatherapy and pre- and post-clinic survey on the days you participate in bladder Botox procedures.

Interventions

Lavender aromatherapy sticker BEHAVIORAL

Lavender aromatherapy during procedure, music and dim lighting

Also known as: music and dim lighting

Lavender aromatherapy sticker; Procedure Team Intervention - relaxing environment

Eligibility Criteria

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

You may qualify if:

• Non-pregnant females
• Age 18 years and older
• English as a primary language
• Scheduled for office intra-detrusor chemodenervation for diagnosis of Over-Active Bladder (OAB)/ Urinary Urgency (UU)/ Urged Urinary Incontinence (UUI)
• Baseline visual analog scale for anxiety ≥12mm

You may not qualify if:

• Allergy to lavender oil
• Contraindication to intra-detrusor chemodenervation (active Urinary Tract Infection)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain; Burnout, Professional

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Occupational Stress; Occupational Diseases; Burnout, Psychological; Stress, Psychological; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Erin Franks
• Organization: Atrium Health Wake Forest Baptist

erin.franks@atriumhealth.org

7043041160

Study Officials

• Megan Tarr, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: May 22, 2024
• Primary Completion: August 12, 2024
• Study Completion: August 12, 2024
• Last Updated: April 22, 2025
• Results First Posted: April 22, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)