Stress, PsychologicalNCT04292145
Effectiveness of Relaxation Techniques
A study testing Relaxation Application and Relaxation Only in people with Stress, Psychological, run by Sarah Corner at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- Relaxation Application and Relaxation Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2020to 22 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Student enrolled in SMU
- Speaks English
Who cannot join
- Must have an Apple Watch to use during time of participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Southern Methodist University
Dallas, Texas, 75206
Alicia E Meuret, PhD, 214-768-3422, ameuret@smu.edu
About this study
Official title: 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.
- Conditions
- Stress, Psychological
- Being tested
- Relaxation Application, Relaxation Only
- Keywords
- breathe, breathing, relax, relaxation, respiration, stress
- Medical subject headings
- Stress, Psychological, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation ApplicationBehavioural
The use of an application for relaxation.
Relaxation OnlyBehavioural
The individual's personal method to relax.
| Study group | Role | What they receive |
|---|---|---|
| Relaxation Application | Experimental | Participants will follow the relaxation application. Receives: Behavioral: Relaxation Application |
| Relaxation Only | Active comparator | Participants will use any relaxation technique they normally use to relax. Receives: Behavioral: Relaxation Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensations Questionnaire
Perceived bodily sensations. Scores range from 10-100, where higher scores indicate sensitivity to bodily sensations.
Measured: at study completion, up to 2 years
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.
Measured: at study completion, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start22 Apr 2020
- Primary completion22 Apr 2024 (estimated)
- Study completion22 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of the two groups as they enter the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sarah Corner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sarah Corner, Southern Methodist University
- Investigators
- Richard Y Kim, BA, Principal investigator, Southern Methodist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292145
- Sponsor's protocol ID
- H19-130-MEUA
- Status last verified
- Apr 2024
- First submitted
- 7 Feb 2020
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Application as a Relaxation Technique
- ClinicalTrials.gov ID
- NCT04292145
- Acronym / sponsor ID
- H19-130-MEUA
- Conditions
- Stress, Psychological
- Keywords
- breathe, breathing, relax, relaxation, respiration, stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sarah CornerUniversity, hospital or other
- Study start
- 22 Apr 2020 (actual)
- Primary completion
- 22 Apr 2024 (estimated)
- Study completion
- 22 Dec 2024 (estimated)
- First posted
- 2 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of the two groups as they enter the study.
| Arm | Type | Receives |
|---|---|---|
| Relaxation Application | Experimental | Behavioral: Relaxation ApplicationParticipants will follow the relaxation application. |
| Relaxation Only | Active comparator | Behavioral: Relaxation OnlyParticipants will use any relaxation technique they normally use to relax. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Student enrolled in SMU
- Speaks English
Key exclusion criteria (1 listed)
- Must have an Apple Watch to use during time of participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relaxation ApplicationThe use of an application for relaxation. | Behavioural | Relaxation Application |
| Relaxation OnlyThe individual's personal method to relax. | Behavioural | Relaxation Only |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Y Kim, BA principal investigator
Southern Methodist University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation Application and Relaxation Only in people with Stress, Psychological, run by Sarah Corner at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard Y Kim, BA (214-768-1291, richardk@smu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensations Questionnaire (time frame: at study completion, up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.