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

NCT ID: NCT03078790

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-13
• Study Completion Date: 2017-07-19

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.

Conditions

Anxiety

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

meditation module

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

Group Type: EXPERIMENTAL

iPad

Intervention Type: DEVICE

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

Interventions

iPad

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Natalie A. Laska

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

16-005071

Identifier Type: -

Identifier Source: org_study_id