- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02990208
Diaphragmatic Breathing During Virtual Reality Exposure Therapy for Aviophobia
December 7, 2016 updated by: Shiban Youssef, University of Regensburg
Diaphragmatic Breathing During Virtual Reality Exposure Therapy for Aviophobia: Functional Coping Strategy or Avoidance Behavior? A Pilot Study
The study investigated the effect of diaphragmatic breathing as an additional coping strategy during Virtual Reality Exposure Therapy in patients with aviophobia.
The authors assumed that diaphragmatic breathing (DB) would lead to less fear and physiological arousal during the VRET and to an enhanced treatment outcome
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients with aviophobia received treatment in Virtual Reality with or without DB.
The authors assumed that adding DB to VRET would enhance treatment effects by reducing fear during exposure, thus improving the processing of the feared situation.
The authors hypothesized that, as a result, self-efficacy would be increased in comparison to VRET alone.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age 20 to 65
- flying experience
- subjective rating of fear of flying > 60 from 100
Exclusion Criteria:
- pregnancy
- heart disease
- current involvement in psychotherapy and/or pharmacotherapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VR exposure + diaphragmatic breathing
Virtual Reality Exposure Therapy + Diaphragmatic breathing
|
Patients trained in the technique of diaphragmatic breathing were instructed to take a breath by contracting the diaphragm and were trained to maintain their respiration frequency.
They were told to inhale through the nose for four seconds and exhale through the mouth for six seconds (six cycles per minute).
Patients then had five minutes to practice by following verbal breathing instructions provided over headphones.
During VR exposure breathing instructions were provided via headphones.
Diaphragmatic is thought to reduce arousal on the physiological level (Hazlett-Stevens & Craske, 2009) but at the same time not to divert attention from the feared situation to the same extent as other coping strategies
Exposure to fear-evoking stimuli is conducted more often in virtual environments using simulators or similar computer-technologies (Virtual Reality Exposure Therapy, VRET).
One great advantage of using VR-technologies is that it is possible to create an environment which is highly controllable by its creators.
Feared stimuli or scenarios can be varied on individual purposes and presented several times.
This facilitates the practice of exposure-based treatments especially for situations or places difficult to access or requiring a considerable amount of time and/or money (e.g.
being in war zones or a passenger on a flight), where in vivo exposures have often not been conducted or only in a limited manner (Mühlberger & Pauli, 2011)
|
Active Comparator: VR exposure
Virtual Reality Exposure Therapy
|
Exposure to fear-evoking stimuli is conducted more often in virtual environments using simulators or similar computer-technologies (Virtual Reality Exposure Therapy, VRET).
One great advantage of using VR-technologies is that it is possible to create an environment which is highly controllable by its creators.
Feared stimuli or scenarios can be varied on individual purposes and presented several times.
This facilitates the practice of exposure-based treatments especially for situations or places difficult to access or requiring a considerable amount of time and/or money (e.g.
being in war zones or a passenger on a flight), where in vivo exposures have often not been conducted or only in a limited manner (Mühlberger & Pauli, 2011)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in FFS (Fear of Flying Scale) scores
Time Frame: immediately before the exposure session, immediately after the exposure session, immediately before the test session (which took place one week after the exposure session), immediately after the test session, in a follow up (one year later)
|
The Fear of Flying Scale (FFS; German version (Mühlberger & Pauli, 2011)) covers 21 flight situations (e.g., planning the trip, boarding a plane, turbulence during the flight) rated on a 5-point Likert scale
|
immediately before the exposure session, immediately after the exposure session, immediately before the test session (which took place one week after the exposure session), immediately after the test session, in a follow up (one year later)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in fear ratings
Time Frame: both during the VR flights (consisting of four 2-min phases each) of the exposure and the test session. Ratings were asked one minute after the beginning of each phase of each flight.
|
Patients were asked to rate their current fear on a scale from 0 (no fear) to 100 (extreme fear)
|
both during the VR flights (consisting of four 2-min phases each) of the exposure and the test session. Ratings were asked one minute after the beginning of each phase of each flight.
|
Change in heart rate
Time Frame: during the four 2-min phases of each of the three VR flights of the exposure session and of each of the two VR flights of the test session.
|
during the four 2-min phases of each of the three VR flights of the exposure session and of each of the two VR flights of the test session.
|
|
Change in electrodermal activity (skin conductance level)
Time Frame: during the four 2-min phases of each of the three VR flights of the exposure session and of each of the two VR flights of the test session.
|
during the four 2-min phases of each of the three VR flights of the exposure session and of each of the two VR flights of the test session.
|
|
Change in self-efficacy scores
Time Frame: immediately before the exposure session, immediately after the exposure session, immediately before the test session (which took place one week after the exposure session), immediately after the test session, in a follow up (one year later)
|
immediately before the exposure session, immediately after the exposure session, immediately before the test session (which took place one week after the exposure session), immediately after the test session, in a follow up (one year later)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
December 5, 2016
First Submitted That Met QC Criteria
December 7, 2016
First Posted (Estimate)
December 13, 2016
Study Record Updates
Last Update Posted (Estimate)
December 13, 2016
Last Update Submitted That Met QC Criteria
December 7, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BREATH150521014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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