Effect of Environment on the Central and Peripheral Nervous System (RUMI)

March 24, 2025 updated by: Susan Rodriguez, University of South Florida
The main goal of this study is to understand how different environments influence both mental responses, like overthinking (rumination), and physical reactions, such as heart rate and blood pressure, after a challenging task.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This study aims to explore the restorative effects of nature exposure on rumination- a mental process that affects attention-and cardiovascular responses to a challenging task. A total of 95 participants will be randomly assigned to either a built or natural environment. Each participant will take part in a 2.5-hour session. Initially, an electrocardiogram (ECG) will be attached to measure heart activity. Participants will then engage in a 30-minute task designed to immerse them in their assigned environment (the ABC engagement task). Following this, they will have a 10-minute period of quiet relaxation to establish baseline cardiovascular measures. After baseline, participants will complete a challenging task (the Remote Associates Test (RAT)), which is designed to induce sympathetic arousal. Afterward, they will rest quietly for another 10 minutes to monitor cardiovascular recovery. Finally, participants will complete post-task surveys through Qualtrics, assessing their state of rumination, perceived difficulty of the task, effort levels, and expectations of success.

Study Type

Interventional

Enrollment (Estimated)

95

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 Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33620
        • University of South Florida

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Individuals 18 years of age or older.

Exclusion Criteria:

  • Individuals with a history of cardiovascular disease or disorders, those who are pregnant, or are taking medications which may alter/affect cardiovascular function.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Built environment assignment
Participants will complete the study session in a built environment
Other: Built environment
Participants will complete the study session at a University student center.
Experimental: Natural environment
Participants will complete the study session in a natural environment.
Other: Natural environment
Participants will complete the study session in a nature trail.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory Sinus Arrhythmia (RSA)
Time Frame: Respiratory sinus arrhythmia will be measured during a baseline (20 minutes), challenging task (19 minutes) and the recovery period (10 minutes).
Respiratory sinus arrhythmia will be measured during a baseline (20 minutes), challenging task (19 minutes) and the recovery period (10 minutes).
Blood pressure
Time Frame: Systolic (SBP) and diastolic blood pressure (DBP) will be measured during a baseline (20 minutes), challenging task (19 minutes), and recovery period (10 minutes).
Systolic (SBP) and diastolic blood pressure (DBP) will be measured during a baseline (20 minutes), challenging task (19 minutes), and recovery period (10 minutes).
Remote Associates Test (RAT)
Time Frame: Participants will complete the RAT task for 19 minutes (44 trials).
In this study, the remote associates test (RAT) will be used as a challenging task to induce sympathetic arousal. Each RAT item consists of three words, participants will be asked to generate a fourth word/solution associated with the words presented by means of a compound word, synonymy, or semantic association. The participant has provided a fourth/solution word or the 30 second time limit. The task will consist of a total of 39 trials, including 5 practice trials.
Participants will complete the RAT task for 19 minutes (44 trials).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

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)

February 14, 2025

Primary Completion (Estimated)

May 20, 2026

Study Completion (Estimated)

May 20, 2026

Study Registration Dates

First Submitted

January 10, 2025

First Submitted That Met QC Criteria

January 15, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY007343

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

product manufactured in and exported from the U.S.

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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