Implementing a Paced Deep Breathing Module to Decrease Preoperative Anxiety in Gynecological Surgery Patients

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT03078790
Collaborator
(none)
38
1
1
4.2
9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: iPad
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Implementing a Paced Deep Breathing Module to Decrease Preoperative Anxiety in Gynecological Surgery Patients
Actual Study Start Date :
Mar 13, 2017
Actual Primary Completion Date :
Jul 19, 2017
Actual Study Completion Date :
Jul 19, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: meditation module

The patients in this arm will be offered the meditation/deep breathing module in the pre-operative area.

Device: iPad
a 10 minute electronic guided deep breathing module offered via an iPad

Outcome Measures

Primary Outcome Measures

  1. change from baseline anxiety score [recorded immediately pre-intervention and immediately post-intervention (once meditation module is complete)]

    rated 0 (no anxiety) to 10 (worst anxiety possible) on a numeric rating scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Natalie A. Laska, Principle investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT03078790
Other Study ID Numbers:
  • 16-005071
First Posted:
Mar 13, 2017
Last Update Posted:
Apr 16, 2019
Last Verified:
Apr 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 16, 2019