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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05694468
Other study ID # 28122022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 22, 2021
Est. completion date June 9, 2021

Study information

Verified date January 2023
Source University of Évora
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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).


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


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 9, 2021
Est. primary completion date June 9, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Psychomotor Relaxation
Psychomotor relaxation sessions.

Locations

Country Name City State
Portugal Andreia Dias Rodrigues Évora

Sponsors (1)

Lead Sponsor Collaborator
University of Évora

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Stress Stress was measured through the Portuguese version of the Perceived Stress Scale (PSS-10). 1, 4 and 12 weeks.
Primary 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. 2 days
Primary Change in Affective states Affective states were measured through the Portuguese short version of the Profile of Mood States (POMS). 1, 4 and 12 weeks.
Primary Change in Interoceptive awareness Interoceptive awareness was measured through the Portuguese version of the Multidimensional Assessment of Interoceptive Awareness (MAIA). 1, 4 and 12 weeks.
Primary Change in Psychological wellbeing Psychological wellbeing was measured through the Portuguese short version of the Scales of Psychological Wellbeing (EBEP). 1, 4 and 12 weeks.
Primary 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. 1 day (after the intervention program)
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