NCT05694468

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 23, 2023

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

December 28, 2022

Last Update Submit

January 21, 2023

Conditions

Stress

Keywords

social-emotional developmentbody-oriented interventionstresshigher education

Outcome Measures

Primary Outcomes (6)

  • Change in Stress

    Stress was measured through the Portuguese version of the Perceived Stress Scale (PSS-10).

    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.

    2 days

  • 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.

  • 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.

  • 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.

  • 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)

Study Arms (1)

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.

Other: Psychomotor Relaxation

Interventions

Psychomotor RelaxationOTHER

Psychomotor relaxation sessions.

Control and Intervention group

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andreia Dias Rodrigues

Evora, 7000-847, Portugal

Location

Study Officials

  • Andreia D Rodrigues, M

    PhD student

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 28, 2022

First Posted

January 23, 2023

Study Start

March 22, 2021

Primary Completion

June 9, 2021

Study Completion

June 9, 2021

Last Updated

January 25, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)