RECRUITING

Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is being done to see if nitrous oxide during vasectomy decreases pain and anxiety, and also assess whether patients have better satisfaction when they control their own level of nitrous oxide during the procedure. If we find that patients experience less pain or anxiety with nitrous oxide, it could be suggested that self-adjusted nitrous oxide (SANO) may be a useful tool for improving experience of care during vasectomy.

Official Title

Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy

Quick Facts

Study Start:2023-05-24
Study Completion:2025-01-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05895383

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 85 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Scheduled for vasectomy
  2. 2. Aged 21 to 85 years
  3. 3. Suitable for receipt of inhaled nitrous oxide/oxygen
  4. 4. Access to an email and computer
  1. 1. Perioral facial hair impeding good mask seal
  2. 2. Cognitive impairment that impedes ability to complete survey questions
  3. 3. Intent to use benzodiazepines or opioids "as needed" for purposes of vasectomy
  4. 4. Has any of the following medical conditions, which contraindicate use of nitrous oxide:
  5. 1. Inner ear, bariatric or eye surgery within the last 2 weeks,
  6. 2. Current emphysematous blebs,
  7. 3. Severe B-12 deficiency,
  8. 4. Bleomycin chemotherapy within the past year,
  9. 5. Heart attack within the past year,
  10. 6. Stroke within the past year,
  11. 7. Class III or higher heart failure.

Contacts and Locations

Study Contact

Heidi Rayala, MD, PhD
CONTACT
617-667-3739
hrayala@bidmc.harvard.edu
Michelle Shabo, MD
CONTACT
mshabo@bidmc.harvard.edu

Principal Investigator

Heidi Rayala, MD, PhD
PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Marissa Kent, MD
STUDY_CHAIR
Beth Israel Deaconess Medical Center
Peter Steinberg, MD
STUDY_CHAIR
Beth Israel Deaconess Medical Center

Study Locations (Sites)

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Beth Israel Deaconess Medical Center

  • Heidi Rayala, MD, PhD, PRINCIPAL_INVESTIGATOR, Beth Israel Deaconess Medical Center
  • Marissa Kent, MD, STUDY_CHAIR, Beth Israel Deaconess Medical Center
  • Peter Steinberg, MD, STUDY_CHAIR, Beth Israel Deaconess Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-24
Study Completion Date2025-01-30

Study Record Updates

Study Start Date2023-05-24
Study Completion Date2025-01-30

Terms related to this study

Keywords Provided by Researchers

  • vasectomy
  • nitrous oxide
  • experience of care
  • ambulatory

Additional Relevant MeSH Terms

  • Procedural Pain
  • Pain Catastrophizing
  • Procedural Anxiety