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NCT03078790 · ClinicalTrials.gov registry record · NA
Implementing a Paced Deep Breathing Module to Decrease Preoperative Anxiety in Gynecological Surgery Patients
A NA study, sponsored by Mayo Clinic.
- Completed
- Registry status
- NA
- Development phase
- 38
- Enrollment target
NCT03078790: Completed NA study, sponsored by Mayo Clinic.
NCT03078790 is a NA study that has completed, run by Mayo Clinic. The registered enrollment target is 38 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03078790, a NA study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 38 participants
- Enrollment target
Study 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 imple
Primary Outcome
rated 0 (no anxiety) to 10 (worst anxiety possible) on a numeric rating scale
Interventions
- DEVICE iPad
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2017-03-13 |
| Est. Completion | 2017-07-19 |
| Phase | NA |
What the finished NCT03078790 record still lists
NCT03078790 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which iPad is the first listed.
NCT03078790 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03078790 about?
NCT03078790 is a clinical study titled "Implementing a Paced Deep Breathing Module to Decrease Preoperative Anxiety in Gynecological Surgery Patients". 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 ...
What is the current status of trial NCT03078790?
This trial is currently completed. It is a NA study. The enrollment target is 38 participants. The study started on 2017-03-13. Estimated completion is 2017-07-19.
What interventions are being tested in trial NCT03078790?
The interventions under investigation include: iPad (DEVICE).
Who is sponsoring clinical trial NCT03078790?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03078790's enrollment target sits among peer trials
38 1538th of 2000 higher than 461 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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