Effects on Mindfulness Meditation on Patient's Satisfaction During Urodynamic Study

NCT04446143 | Completed

• 1 other identifier: 5200230
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this investigator-initiated study is to evaluate if mindfulness-based stress reduction (MBSR) will improve satisfaction and reduce anxiety during a urodynamic study (UDS).

Conditions

Personal Satisfaction

Keywords

meditation, urodynamics, satisfaction, pain, anxiety

Outcome Measures

Primary Outcomes (1)

• Satisfaction during the urodynamic study testing

  Likert scale will measure satisfaction with urodynamics in both groups. The scale ranges are: very dissatisfied=0, dissatisfied=1, somehow satisfied=2, satisfied=3, very satisfied=4), with 0 as the worse outcome.

  1 year

Secondary Outcomes (2)

• Self evaluation of anxiety and comfort level

  1 year

• Pain level

  1 year

Study Arms (2)

Application of mindfulness meditation prior to UDS

OTHER

Those in the mindfulness medication group will listen to an audio-taped mediation, which takes 10 mins to complete.

Behavioral: Mindfulness meditation

No meditation prior to UDS

ACTIVE COMPARATOR

The control group will be seated in a quiet empty room where they wait for 10 min.

Behavioral: Mindfulness meditation

Interventions

Mindfulness meditation BEHAVIORAL

Mindfulness meditation

Application of mindfulness meditation prior to UDS; No meditation prior to UDS

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: All genders and gender-identities (phenotype, genotype) are eligible for this study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female and male patients between ages 18 and 99 with clinical indication for UDS ordered by treating physician

You may not qualify if:

• None English speakers will be recruited for this study.
• Pregnancy
• Prioners

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Faculty Medical Offices

Loma Linda, California, 92354, United States

Location

Related Publications (1)

• Uberoi P, Smitherman A, Aden J, Park G, Jellison F. Incorporation of Mindfulness Exercises to Reduce Anxiety During Urodynamic Testing: A Randomized Single-Blind Controlled Pilot Trial. J Altern Complement Med. 2020 Jan;26(1):74-75. doi: 10.1089/acm.2018.0447. Epub 2019 Sep 25. No abstract available.

  PMID: 31553223 BACKGROUND

MeSH Terms

Conditions

Personal Satisfaction; Pain; Anxiety Disorders

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Andrea Staack

  Loma Linda Univ Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Subject randomization will use permutated blocks and assignments in concealed consecutively numbered envelops. Those in the mindfulness medication group will listen to an audio-taped mediation, which takes 10 mins to complete, where as the control group will be seated in a quiet empty room where they wait for 10 min.

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 24, 2020
• Study Start: December 1, 2020
• Primary Completion: July 15, 2021
• Study Completion: July 15, 2021
• Last Updated: February 15, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)