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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT05895383
Phase
PHASE4
Status
Recruiting
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Conditions

  • Pain Catastrophizing
  • Procedural Anxiety
  • Procedural Pain

Eligibility Criteria

Sex
MALE
Age
21 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Nitrous oxide — DRUG
    Nitrous oxide administered at concentrations of minimal sedation (0-50%). Participants will be able to adjust the level of gas throughout the vasectomy using a handheld remote control.

Study Details

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.

Key Dates

Start date
May 24, 2023
Status verified
Feb 2026
Primary completion
Jan 30, 2027
Completion
Jan 30, 2027

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Self-adjusted nitrous oxide (SANO)
    All patients will receive nitrous oxide at concentrations of minimal sedation (0-50%) throughout vasectomy.

Primary Outcome Measure

Procedural pain assessed by the Visual Analog Scale for Pain (VAS-P) [ Time Frame: Measured immediately after completion of vasectomy ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215

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Beth Israel Deaconess Medical Center· Boston, MA

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