Feasibility StudiesNCT07910695
Feasibility Study of a Relaxation and Guided Imagery Intervention Research Protocol for Use in School Settings.
A study testing Relaxation and Guided Imagery and Progressive Muscle Relaxation in people with Feasibility Studies and Acceptability, run by Pace University.
Trial summary
The goal of this study is to gather information that (1) will be used to determine whether or not a research protocol for investigating the efficacy of a relaxation and guided imagery intervention for improving K-12 students' social-emotional, behavioral, and learning outcomes is feasible for use in school settings… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Feasibility Studies, Acceptability, Pilot Study
- What is being tested?
- Relaxation and Guided Imagery and Progressive Muscle Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2029to 1 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Be a student or educational staff member in a participating K-12 school located within the United States of America.
- Must report English as their primary language.
Who cannot join
- Do not meet inclusion criteria
- Have physical conditions that limit participation in a relaxation and guided imagery treatment.
About this study
Official title: Testing the Feasibility and Acceptability of a Relaxation and Guided Imagery Research Protocol in School Settings
The goal of this study is to gather information that (1) will be used to determine whether or not a research protocol for investigating the efficacy of a relaxation and guided imagery intervention for improving K-12 students' social-emotional, behavioral, and learning outcomes is feasible for use in school settings and (2) can be used to refine the research protocol.
Read the detailed description
To evaluate the feasibility and acceptability of a Relaxation and Guided Imagery (RGI) intervention and associated intervention research protocol in K-12 school settings. The study will refine the RGI intervention and study procedures and gather the feasibility, implementation, outcome variability, and preliminary between-group effect-size parameters necessary to design a subsequent, adequately powered full-scale randomized clinical trial.
- Conditions
- Feasibility Studies, Acceptability, Pilot Study
- Being tested
- Relaxation and Guided Imagery, Progressive Muscle Relaxation
- Keywords
- feasibility, relaxation and guided imagery, school research, student outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation and Guided ImageryBehavioural
Performing a relaxation technique then listening to a short script detailing calming imagery.
Progressive Muscle RelaxationBehavioural
Guided sequential muscle tensing followed by muscle relaxation by muscle group.
| Study group | Role | What they receive |
|---|---|---|
| Relaxation and Guided Imagery | Experimental | An intervention research protocol, developed to test the efficacy of a relaxation and guided imagery intervention in school settings, will be implemented to evaluate feasibility. RGI includes performing a relaxation technique then listening to a short script detailing calming imagery. Receives: Behavioral: Relaxation and Guided Imagery |
| Progressive Muscle Relaxation | Active comparator | Participants in this condition will receive the same research procedures as those assigned to the RGI group, however, they will receive Progressive Muscle Relaxation as an intervention rather than the RGI. Progressive Muscle Relaxation includes guided sequential muscle tensing followed by muscle relaxation by muscle group. Receives: Behavioral: Progressive Muscle Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants' perceptions of intervention feasibility and acceptability
Proportion of participants reporting favorable feasibility and acceptability ratings relative to implementing an intervention in a school setting with K-12 students. Reporting outcomes of the Usage Rating Profile - Intervention Acceptability Scale (min score = 9, max score = 54) and Feasibility Scale (min score = 6, max score = 36)
Measured: At intervention completion, an average of 3 months.
Participants' perceptions of assessment procedure feasibility and acceptability
Proportion of participants reporting favorable feasibility and acceptability ratings relative to implementation of data collection procedures in school settings. Reporting outcomes of the Usage Rating Profile - Assessment Acceptability Scale (min score = 9, max score = 54) and Feasibility Scale (min score = 6, max score = 36)
Measured: At intervention completion, an average of 3 months.
Child participants' perceptions of intervention feasibility and acceptability
Proportion of participants reporting favorable feasibility ratings relative to using an intervention in school settings. Reporting outcomes of the Children's Usage Rating Profile Feasibility Scale (min score = 7, max score = 42).
Measured: At intervention completion, an average of 3 months.
Researcher Developed Qualitative Feedback Questionnaire for Educational Personnel
Semantic themes in educational personnel's satisfaction with research procedures and feedback for improvement. Reporting outcomes of qualitative data (thematic analysis).
Measured: At intervention completion, an average of 3 months.
Researcher Developed Qualitative Feedback Questionnaire for Students
Semantic themes in students' satisfaction with research procedures and feedback for improvement. Reporting outcomes of qualitative data (thematic analysis).
Measured: At intervention completion, an average of 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Sep 2029 (estimated)
- Primary completion1 Jul 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feasibility StudiesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pace University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Connecticut
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910695
- Sponsor's protocol ID
- PAR25274 RGI Feasibility Study
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Results of this study will not be published in an ICMJE journal. This is a feasibility/pilot study for which analyses of IPD will not yield generalizable results due to insufficient sample size.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Feasibility and Acceptability of a Relaxation and Guided Imagery Research Protocol in School Settings
- ClinicalTrials.gov ID
- NCT07910695
- Acronym / sponsor ID
- PAR25274 RGI Feasibility Study
- Conditions
- Feasibility Studies, Acceptability, Pilot Study
- Keywords
- feasibility, relaxation and guided imagery, school research, student outcomes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- Pace UniversityUniversity, hospital or other
- Collaborators
- University of Connecticut
- Study start
- 1 Sep 2029 (estimated)
- Primary completion
- 1 Jul 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 2 Nov 2026 (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 goal of this study is to gather information that (1) will be used to determine whether or not a research protocol for investigating the efficacy of a relaxation and guided imagery intervention for improving K-12 students' social-emotional, behavioral, and learning outcomes is feasible for use in school settings and (2) can be used to refine the research protocol.
Detailed description
To evaluate the feasibility and acceptability of a Relaxation and Guided Imagery (RGI) intervention and associated intervention research protocol in K-12 school settings. The study will refine the RGI intervention and study procedures and gather the feasibility, implementation, outcome variability, and preliminary between-group effect-size parameters necessary to design a subsequent, adequately powered full-scale randomized clinical trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relaxation and Guided Imagery | Experimental | Behavioral: Relaxation and Guided ImageryAn intervention research protocol, developed to test the efficacy of a relaxation and guided imagery intervention in school settings, will be implemented to evaluate feasibility. RGI includes performing a relaxation technique then listening to a short script detailing calming imagery. |
| Progressive Muscle Relaxation | Active comparator | Behavioral: Progressive Muscle RelaxationParticipants in this condition will receive the same research procedures as those assigned to the RGI group, however, they will receive Progressive Muscle Relaxation as an intervention rather than the RGI. Progressive Muscle Relaxation includes guided sequential muscle tensing followed by muscle relaxation by muscle group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Be a student or educational staff member in a participating K-12 school located within the United States of America.
- Must report English as their primary language.
Key exclusion criteria (2 listed)
- Do not meet inclusion criteria
- Have physical conditions that limit participation in a relaxation and guided imagery treatment.
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 and Guided ImageryPerforming a relaxation technique then listening to a short script detailing calming imagery. | Behavioural | Relaxation and Guided Imagery |
| Progressive Muscle RelaxationGuided sequential muscle tensing followed by muscle relaxation by muscle group. | Behavioural | Progressive Muscle Relaxation |
Primary outcome
Participants' perceptions of intervention feasibility and acceptability
Time frame: At intervention completion, an average of 3 months.
Proportion of participants reporting favorable feasibility and acceptability ratings relative to implementing an intervention in a school setting with K-12 students. Reporting outcomes of the Usage Rating Profile - Intervention Acceptability Scale (min score = 9, max score = 54) and Feasibility Scale (min score = 6, max score = 36)
Participants' perceptions of assessment procedure feasibility and acceptability
Time frame: At intervention completion, an average of 3 months.
Proportion of participants reporting favorable feasibility and acceptability ratings relative to implementation of data collection procedures in school settings. Reporting outcomes of the Usage Rating Profile - Assessment Acceptability Scale (min score = 9, max score = 54) and Feasibility Scale (min score = 6, max score = 36)
Child participants' perceptions of intervention feasibility and acceptability
Time frame: At intervention completion, an average of 3 months.
Proportion of participants reporting favorable feasibility ratings relative to using an intervention in school settings. Reporting outcomes of the Children's Usage Rating Profile Feasibility Scale (min score = 7, max score = 42).
Researcher Developed Qualitative Feedback Questionnaire for Educational Personnel
Time frame: At intervention completion, an average of 3 months.
Semantic themes in educational personnel's satisfaction with research procedures and feedback for improvement. Reporting outcomes of qualitative data (thematic analysis).
Researcher Developed Qualitative Feedback Questionnaire for Students
Time frame: At intervention completion, an average of 3 months.
Semantic themes in students' satisfaction with research procedures and feedback for improvement. Reporting outcomes of qualitative data (thematic analysis).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Undecided. Results of this study will not be published in an ICMJE journal. This is a feasibility/pilot study for which analyses of IPD will not yield generalizable results due to insufficient sample size.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation and Guided Imagery and Progressive Muscle Relaxation in people with Feasibility Studies and Acceptability, run by Pace University.
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 2 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants' perceptions of intervention feasibility and acceptability (time frame: At intervention completion, an average of 3 months.). The study lists 5 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 2 Nov 2026.