- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04292145
Effectiveness of Relaxation Techniques
April 18, 2023 updated by: Sarah Corner
Efficacy of an Application as a Relaxation Technique
The study aims to assess the validity of a relaxation app.
This will be accomplished by obtaining self-report measures about mood and respiratory symptoms.
We hypothesize that self-report in the relaxation app condition will be different from that of the relaxation only condition.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Richard Y Kim, BA
- Phone Number: 214-768-1291
- Email: richardk@smu.edu
Study Contact Backup
- Name: Alicia E Meuret, PhD
- Phone Number: 214-768-3422
- Email: ameuret@smu.edu
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75206
- Recruiting
- Southern Methodist University
-
Contact:
- Alicia E Meuret, PhD
- Phone Number: 214-768-3422
- Email: ameuret@smu.edu
-
-
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
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Student enrolled in SMU
- Speaks English
Exclusion Criteria:
- Must have an Apple Watch to use during time of participation in the study
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: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Relaxation Application
Participants will follow the relaxation application.
|
The use of an application for relaxation.
|
Active Comparator: Relaxation Only
Participants will use any relaxation technique they normally use to relax.
|
The individual's personal method to relax.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensations Questionnaire
Time Frame: at study completion, up to 2 years
|
Perceived bodily sensations.
Scores range from 10-100, where higher scores indicate sensitivity to bodily sensations.
|
at study completion, up to 2 years
|
Positive and Negative Affect Schedule
Time Frame: at study completion, up to 2 years
|
Immediate experience of mood.
The measure consists of two scales, negative and positive items.
Scores range from 10-50 for the positive scale, where higher scores indicate greater positive mood, and scores range from 10-50 for the negative scale, where higher scores indicate greater negative mood.
|
at study completion, up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Richard Y Kim, BA, Southern Methodist University
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 (Actual)
April 22, 2020
Primary Completion (Anticipated)
October 22, 2023
Study Completion (Anticipated)
October 22, 2023
Study Registration Dates
First Submitted
February 7, 2020
First Submitted That Met QC Criteria
February 28, 2020
First Posted (Actual)
March 2, 2020
Study Record Updates
Last Update Posted (Actual)
April 19, 2023
Last Update Submitted That Met QC Criteria
April 18, 2023
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H19-130-MEUA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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