Preoperative Mindfulness: Minimally Invasive Hysterectomy

Sponsor

Montefiore Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05157490

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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 Headspace™. 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. We hypothesize that mindfulness practiced in the form of meditation delivered via an internet application will lead to reduced pain scores on postoperative day 1.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Behavioral: Mindfulness training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Preoperative Mindfulness In Patients Undergoing Minimally Invasive Hysterectomy: A Randomized Controlled Trial

Anticipated Study Start Date :

Sep 30, 2022

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Jan 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mindfulness training Completion of guided meditations in the preoperative time period, at least 3 sessions per week, leading up to surgery	Behavioral: Mindfulness training Guided meditations in the preoperative time period, at least 3 sessions per week, leading up to surgery
No Intervention: Control

Arm

Intervention/Treatment

Experimental: Mindfulness training

Completion of guided meditations in the preoperative time period, at least 3 sessions per week, leading up to surgery

Behavioral: Mindfulness training

Guided meditations in the preoperative time period, at least 3 sessions per week, leading up to surgery

No Intervention: Control

Outcome Measures

Primary Outcome Measures

Pain score [1 day]
Postoperative day 1 pain score using Numeric Pain Rating Scale

Secondary Outcome Measures

QOR-15 score [7 days]
Quality of Recovery Score
PSS-10 score [7 days]
Perceived Stress Scale
Opioid consumption [7 days]
number of opioid tablets used postoperatively

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Montefiore Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Montefiore Medical Center

ClinicalTrials.gov Identifier:

NCT05157490

Other Study ID Numbers:

2020-12609

First Posted:

Dec 15, 2021

Last Update Posted:

Jul 26, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Jul 26, 2022