Implementing a Paced Deep Breathing Module to Decrease Preoperative Anxiety in Gynecological Surgery Patients
Primary Purpose
Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iPad
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety
Eligibility Criteria
Inclusion Criteria:
- Women
- aged 18 years or older
- undergoing gynecological surgery at Rochester Methodist Hospital
- roomed in pre-operative area on Eisenberg 1-4
- English-speaking
- Able to complete pre- and post-intervention questionnaires
- Able to read and understand informed consent form
Exclusion Criteria:
- Non-English speaking women
- first-case of the day gynecological surgery patients
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
meditation module
Arm Description
The patients in this arm will be offered the meditation/deep breathing module in the pre-operative area.
Outcomes
Primary Outcome Measures
change from baseline anxiety score
rated 0 (no anxiety) to 10 (worst anxiety possible) on a numeric rating scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03078790
Brief Title
Implementing a Paced Deep Breathing Module to Decrease Preoperative Anxiety in Gynecological Surgery Patients
Official Title
Implementing a Paced Deep Breathing Module to Decrease Preoperative Anxiety in Gynecological Surgery Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 13, 2017 (Actual)
Primary Completion Date
July 19, 2017 (Actual)
Study Completion Date
July 19, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Preoperative anxiety is a common occurrence for many patients undergoing all types of surgery. Patients with a high level of anxiety before surgery have been shown to have numerous negative outcomes both intra-operatively and post-operatively. Many studies have shown that preoperative psychological interventions that aim to reduce anxiety also result in improved post-operative behavioral and clinical recovery. Currently, the most common method to treat preoperative anxiety is the administration of a prescription benzodiazepine. However, there is limited clinical evidence that supports the use of sedative premedication, such as with a benzodiazepine, before surgery. Complementary integrative medical therapies including music, massage, guided imagery, and deep breathing have been proposed to minimize stress and pain in surgical patients. These therapies are thought to be effective by evoking the relaxation response through stimulation of the parasympathetic nervous system and engagement of the patient in the healing process. Relaxation and deep breathing, particularly, have been shown to reduce pain, anxiety, and "tension-anxiety" in hospitalized patients. Based on this evidence, a guided paced deep breathing module has been proposed to reduce preoperative anxiety in patients undergoing gynecological surgery at Mayo Clinic Rochester Methodist Hospital. In this study, patients' anxiety will be assessed pre-intervention on a 0-10 numeric rating scale, as well as post-intervention and a paired t-test will be used to assess effectiveness. Additionally, qualitative questions will be administered via a questionnaire post-intervention to gain more insight on the effectiveness of the intervention. The feasibility of the intervention in the busy preoperative setting will be evaluated by assessing how many times a patient is interrupted while participating in the paced deep breathing module. If this module is found to be effective in reducing patients' anxiety, it will be implemented into practice so that every patient undergoing gynecological surgery, at the institution, will be offered the module preoperatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
meditation module
Arm Type
Experimental
Arm Description
The patients in this arm will be offered the meditation/deep breathing module in the pre-operative area.
Intervention Type
Device
Intervention Name(s)
iPad
Intervention Description
a 10 minute electronic guided deep breathing module offered via an iPad
Primary Outcome Measure Information:
Title
change from baseline anxiety score
Description
rated 0 (no anxiety) to 10 (worst anxiety possible) on a numeric rating scale
Time Frame
recorded immediately pre-intervention and immediately post-intervention (once meditation module is complete)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women
aged 18 years or older
undergoing gynecological surgery at Rochester Methodist Hospital
roomed in pre-operative area on Eisenberg 1-4
English-speaking
Able to complete pre- and post-intervention questionnaires
Able to read and understand informed consent form
Exclusion Criteria:
Non-English speaking women
first-case of the day gynecological surgery patients
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Implementing a Paced Deep Breathing Module to Decrease Preoperative Anxiety in Gynecological Surgery Patients
We'll reach out to this number within 24 hrs