- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05694468
The Effects of a Relaxation Intervention on College Students' Social-emotional Competence
The Effects of a Relaxation Intervention on College Students' Social-emotional Competence: A Mixed Methods Approach
Study Overview
Detailed Description
This was a non-random one-group repeated measures study with a mixed approach (quantitative and qualitative analysis), where participants served as their own controls.
The investigators examined the chronic effects of the intervention program, collecting the instruments online at week 1 (pretest 1) and week 5 (pretest 2), to establish the baseline measures, and at the end of the 8-week period (post-test). In the post-test evaluation, participants also completed the questionnaire with open-ended questions. Investigators also measured salivary cortisol at the beginning and end of the 1st and the 15th sessions to evaluate the acute effects of the intervention program.
Students participated in a psychomotor relaxation program comprised by two 20-minute sessions per week for 8 weeks, combining body awareness, muscle tone regulation and breathing exercises
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Évora, Portugal, 7000-847
- Andreia Dias Rodrigues
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age between 18 and 30 years old
- not having participated in a similar intervention program within the last 6 months
- not have a physical condition that can affect participation in the program
- do not take medication that can influence the studied outcomes.
Exclusion Criteria:
- age under 18 or over 30 years old
- have participated in a similar intervention program within the last 6 months
- have a physical condition that can affect participation in the program
- take medication that can influence the studied outcomes.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Control and Intervention group
In this non-random one-group repeated measures study with a mixed approach (quantitative and qualitative analysis), participants were tested on two occasions 4 weeks apart (baseline measure), and then engaged in the psychomotor relaxation program twice weekly for 8 weeks.
Participants were tested again after the intervention program (post-test).
The participants took part in a psychomotor relaxation program comprised by two 20-minute sessions per week for 8 weeks, with the whole class, and combined body awareness, muscle tone regulation and breathing exercises.
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Psychomotor relaxation sessions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Stress
Time Frame: 1, 4 and 12 weeks.
|
Stress was measured through the Portuguese version of the Perceived Stress Scale (PSS-10).
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1, 4 and 12 weeks.
|
|
Cortisol levels
Time Frame: 2 days
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Cortisol levels (mcg/dL) were quantified in saliva samples collected at the same time and in the same place where the intervention occurred.
Before and after the 1st and 15th session, the samples were collected directly from each participant's mouth.
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2 days
|
|
Change in Affective states
Time Frame: 1, 4 and 12 weeks.
|
Affective states were measured through the Portuguese short version of the Profile of Mood States (POMS).
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1, 4 and 12 weeks.
|
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Change in Interoceptive awareness
Time Frame: 1, 4 and 12 weeks.
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Interoceptive awareness was measured through the Portuguese version of the Multidimensional Assessment of Interoceptive Awareness (MAIA).
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1, 4 and 12 weeks.
|
|
Change in Psychological wellbeing
Time Frame: 1, 4 and 12 weeks.
|
Psychological wellbeing was measured through the Portuguese short version of the Scales of Psychological Wellbeing (EBEP).
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1, 4 and 12 weeks.
|
|
Personal and professional development
Time Frame: 1 day (after the intervention program)
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A questionnaire was created to the present study comprising 3 open-ended questions concerning the perception of the students about the influence of the intervention program on their personal development, and the benefits that the intervention program may have in the exercise of their future profession as an early childhood educator.
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1 day (after the intervention program)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andreia D Rodrigues, M, PhD student
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 28122022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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