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Effectiveness of Relaxation Techniques

Primary Purpose

Stress, Psychological

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Relaxation Application
Relaxation Only
Sponsored by
Sarah Corner
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stress, Psychological focused on measuring breathe, breathing, relax, relaxation, respiration, stress

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Student enrolled in SMU
  • Speaks English

Exclusion Criteria:

  • Must have an Apple Watch to use during time of participation in the study

Sites / Locations

  • Southern Methodist UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Relaxation Application

Relaxation Only

Arm Description

Participants will follow the relaxation application.

Participants will use any relaxation technique they normally use to relax.

Outcomes

Primary Outcome Measures

Sensations Questionnaire
Perceived bodily sensations. Scores range from 10-100, where higher scores indicate sensitivity to bodily sensations.
Positive and Negative Affect Schedule
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.

Secondary Outcome Measures

Full Information

First Posted
February 7, 2020
Last Updated
April 18, 2023
Sponsor
Sarah Corner
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1. Study Identification

Unique Protocol Identification Number
NCT04292145
Brief Title
Effectiveness of Relaxation Techniques
Official Title
Efficacy of an Application as a Relaxation Technique
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2020 (Actual)
Primary Completion Date
October 22, 2023 (Anticipated)
Study Completion Date
October 22, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sarah Corner

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological
Keywords
breathe, breathing, relax, relaxation, respiration, stress

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to one of the two groups as they enter the study.
Masking
Participant
Masking Description
Participants will not be aware of the purpose of the study, thus they will not know if they are in the experimental or control group.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Relaxation Application
Arm Type
Experimental
Arm Description
Participants will follow the relaxation application.
Arm Title
Relaxation Only
Arm Type
Active Comparator
Arm Description
Participants will use any relaxation technique they normally use to relax.
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Application
Intervention Description
The use of an application for relaxation.
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Only
Intervention Description
The individual's personal method to relax.
Primary Outcome Measure Information:
Title
Sensations Questionnaire
Description
Perceived bodily sensations. Scores range from 10-100, where higher scores indicate sensitivity to bodily sensations.
Time Frame
at study completion, up to 2 years
Title
Positive and Negative Affect Schedule
Description
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.
Time Frame
at study completion, up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Student enrolled in SMU Speaks English Exclusion Criteria: Must have an Apple Watch to use during time of participation in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard Y Kim, BA
Phone
214-768-1291
Email
richardk@smu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alicia E Meuret, PhD
Phone
214-768-3422
Email
ameuret@smu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Y Kim, BA
Organizational Affiliation
Southern Methodist University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Methodist University
City
Dallas
State/Province
Texas
ZIP/Postal Code
75206
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alicia E Meuret, PhD
Phone
214-768-3422
Email
ameuret@smu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of Relaxation Techniques

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