StressNCT05694468
The Effects of a Relaxation Intervention on College Students' Social-emotional Competence
A study testing Psychomotor Relaxation in people with Stress, run by University of Évora at 1 site in Portugal.
Trial summary
Objective: To examine the impact of a psychomotor relaxation program on college students' social-emotional competence, personal and professional development. Participants: Twenty female college students participated. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Psychomotor Relaxation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePortugal
- Study dates
- 22 Mar 2021to 9 Jun 2021
- 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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of a Relaxation Intervention on College Students' Social-emotional Competence: A Mixed Methods Approach
Objective: To examine the impact of a psychomotor relaxation program on college students' social-emotional competence, personal and professional development. Participants: Twenty female college students participated. Methods: 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).
Read the 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
- Conditions
- Stress
- Being tested
- Psychomotor Relaxation
- Keywords
- social-emotional development, body-oriented intervention, stress, higher education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychomotor RelaxationOther
Psychomotor relaxation sessions.
| Study group | Role | What they receive |
|---|---|---|
| Control and Intervention group | Other | 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. Receives: Other: Psychomotor Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stress
Stress was measured through the Portuguese version of the Perceived Stress Scale (PSS-10).
Measured: 1, 4 and 12 weeks.
Cortisol levels
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.
Measured: 2 days
Change in Affective states
Affective states were measured through the Portuguese short version of the Profile of Mood States (POMS).
Measured: 1, 4 and 12 weeks.
Change in Interoceptive awareness
Interoceptive awareness was measured through the Portuguese version of the Multidimensional Assessment of Interoceptive Awareness (MAIA).
Measured: 1, 4 and 12 weeks.
Change in Psychological wellbeing
Psychological wellbeing was measured through the Portuguese short version of the Scales of Psychological Wellbeing (EBEP).
Measured: 1, 4 and 12 weeks.
Personal and professional development
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.
Measured: 1 day (after the intervention program)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start22 Mar 2021
- Primary completion9 Jun 2021
- Study completion9 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Évora
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreia Dias Rodrigues, University of Évora
- Investigators
- Andreia D Rodrigues, M, Principal investigator, PhD student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694468
- Sponsor's protocol ID
- 28122022
- Status last verified
- Jan 2023
- First submitted
- 28 Dec 2022
- Last updated
- 25 Jan 2023
- Results posted
- 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 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Relaxation Intervention on College Students' Social-emotional Competence: A Mixed Methods Approach
- ClinicalTrials.gov ID
- NCT05694468
- Acronym / sponsor ID
- 28122022
- Conditions
- Stress
- Keywords
- social-emotional development, body-oriented intervention, stress, higher education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ÉvoraUniversity, hospital or other
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 9 Jun 2021 (actual)
- Study completion
- 9 Jun 2021 (actual)
- First posted
- 23 Jan 2023 (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.
Objective: To examine the impact of a psychomotor relaxation program on college students' social-emotional competence, personal and professional development. Participants: Twenty female college students participated. Methods: 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).
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control and Intervention group | Other | Other: Psychomotor RelaxationIn 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Psychomotor RelaxationPsychomotor relaxation sessions. | Other | Control and Intervention group |
Primary outcome
Change in Stress
Time frame: 1, 4 and 12 weeks.
Stress was measured through the Portuguese version of the Perceived Stress Scale (PSS-10).
Cortisol levels
Time frame: 2 days
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.
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).
Change in Interoceptive awareness
Time frame: 1, 4 and 12 weeks.
Interoceptive awareness was measured through the Portuguese version of the Multidimensional Assessment of Interoceptive Awareness (MAIA).
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).
Personal and professional development
Time frame: 1 day (after the intervention program)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- 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.
Andreia D Rodrigues, M principal investigator
PhD student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychomotor Relaxation in people with Stress, run by University of Évora at 1 site in Portugal.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 25 Jan 2023. 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 Portugal. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Stress (time frame: 1, 4 and 12 weeks.). The study lists 6 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 Jan 2023.