Pain, Postoperative Clinical Trial
Official title:
Preoperative Mindfulness In Patients Undergoing Minimally Invasive Hysterectomy: A Randomized Controlled Trial
NCT number | NCT05157490 |
Other study ID # | 2020-12609 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 20, 2023 |
Est. completion date | February 2025 |
This is a randomized control trial investigating the effects of a preoperative mindfulness intervention on postoperative pain, quality of recovery and stress scores in women undergoing minimally invasive hysterectomy. The mindfulness intervention will be delivered via the application Headspaceā¢. The primary outcome will be pain scores measured on postoperative day one. Secondary outcomes will include quality of recovery scores and perceived stress scores measured on postoperative days 1 and 7, amount of opioid consumed, and dose response between number of sessions and/or numbers of minutes of meditation performed on pain and quality of recovery scores. The study team hypothesizes that mindfulness practiced in the form of meditation delivered via an internet application will lead to reduced pain scores on postoperative day 1.
Status | Recruiting |
Enrollment | 72 |
Est. completion date | February 2025 |
Est. primary completion date | February 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Undergo minimally invasive hysterectomy - Fluency in English - Access to a device capable of running the Headspace application (smart phone or computer) Exclusion Criteria: - Minors - Inability to access Headspace app - Inability to complete surveys in English |
Country | Name | City | State |
---|---|---|---|
United States | Montefiore Medical Center-Albert Einstein College of Medicine | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Montefiore Medical Center | Howard University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain score | Postoperative day 1 pain score using Numeric Pain Rating Scale | 1 day | |
Secondary | QOR-15 score | Quality of Recovery Score | 7 days | |
Secondary | PSS-10 score | Perceived Stress Scale | 7 days | |
Secondary | Opioid consumption | Number of opioid tablets used postoperatively | 7 days |
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