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Anxiety StateNCT06341569

Physical Therapy Students: Well-being

A study testing Respiratory breathing techniques group in people with Anxiety State and Motivation, run by University of Medicine and Pharmacy "Victor Babes" Timisoara at 1 site in Romania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to explore various psychosocial aspects and the potential benefits of respiratory techniques for physical therapy students. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Anxiety State, Motivation, Life Stress
What is being tested?
Respiratory breathing techniques group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
1 siteRomania
Study dates
9 May 2024to 30 Oct 2024
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Students: enrolled in the physical therapy study program (year I, II and III) Age: > 18 years Ability to understand and follow instructions Availability to provide informed consent.

Who cannot join

  • Pre-existing medical conditions: uncontrolled medical conditions (cardiovascular disease, severe respiratory problems) Use of psychotropic drugs: drugs that could significantly affect mood, anxiety level, or sleep quality.
  • Pregnancy: due to potential physiological changes that could influence the results of the study.
  • Inability to comply with study requirements: these could include completing questionnaires and participating in the respiratory techniques program (if part of the intervention group).

Trial locations and contacts

1 site in 1 country.

Romania1 site
  • University of Medicine and Pharmacy Victor Babes Timisoara

    Timișoara, Timiș County, 3003001

Other trials in Romania

About this study

Official title: Understanding Well-being in Physical Therapy Students: A Multi-Dimensional Analysis of Motivation, Life Satisfaction, and Perceived Academic Quality

This study aims to explore various psychosocial aspects and the potential benefits of respiratory techniques for physical therapy students.

Read the detailed description

Understanding the psychosocial state of academic students has become a primary concern in contemporary educational research and practice. As students go through the challenges of higher education, factors such as motivation, life satisfaction, and happiness play crucial roles in shaping their academic experiences and outcomes. Therefore, researchers have increasingly turned their attention to studying these elements in order to gain insight into the overall state of students and inform strategies designed to create positive educational outcomes.

The implications of studying motivation, life satisfaction, and happiness among academic students are far-reaching. By gaining a deeper understanding of these psychosocial elements, educators and policymakers can develop interventions and programs designed to cultivate positive learning environments that support students' psychological well-being and academic success. For example, strategies that enhance intrinsic motivation, such as promoting autonomy and providing meaningful learning opportunities, can lead to improved engagement and academic achievement. Similarly, initiatives that promote a sense of belonging and social support can improve students' overall life satisfaction and happiness.

Thus, this study aims to explore various psychosocial aspects and the potential benefits of respiratory techniques for physical therapy students.

Being tested
Respiratory breathing techniques group
Keywords
Students, Physical Therapy, Anxiety, Motivation, Happiness, Breathing techniques
Medical subject headings
Anxiety Disorders, Stress, Psychological, Sleep Deprivation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Respiratory breathing techniques groupOther

    Target group: subjects in the respiratory breathing techniques group. Program duration: the program lasts for 14 weeks.

    Breathing techniques: the program includes various breathing exercises, including:

    Diaphragmatic breathing teaches participants to breathe deeply, engaging the diaphragm muscle, which can improve lung capacity and relaxation.

    Pursed-lips breathing: this technique involves inhaling through the nose and exhaling slowly through pursed lips, which can help slow down breathing and manage shortness of breath.

    Alternate nostril breathing: this technique involves closing one nostril while inhaling and exhaling through the other nostril alternately.

    Relaxation techniques: the program incorporates progressive muscle relaxation techniques. This involves progressively tensing and relaxing different muscle groups.

    Medical education: topics like the anatomy of the respiratory system, the importance of proper breathing, potential benefits of specific breathing exercises.

Study groups in NCT06341569
Study groupRoleWhat they receive
Respiratory breathing techniques groupExperimentalSubjects included in the intervention group will receive a 14 week breathing technique program that will include: different types of breathing techniques (diaphragmatic, pursed-lips, alternate nostril breathing, etc.); progressive muscle relaxation techniques; and medical education about breathing.
Receives: Other: Respiratory breathing techniques group
Control groupNo interventionSecond-year physical therapy students that do not want to participate in the breathing technique program and will complete only the questionnaires.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessing intrinsic and extrinsic motivation levels among physical therapy students.

    The Motivational Styles Questionnaire (MSLQ) assesses students' intrinsic and extrinsic motivation levels. The MSLQ does not have a standard range of minimum and maximum values. Higher scores on intrinsic motivation indicate a better outcome, reflecting a higher level of internal motivation. Conversely, higher scores on extrinsic motivation may suggest a reliance on external rewards or pressures, which could indicate a less favorable outcome.

    Measured: At the beginning of the study

  2. Assessing the happiness levels of the students participating in the study.

    The Oxford Happiness Questionnaire evaluates happiness levels. It ranges from 1 to 6. Higher scores on the Oxford Happiness Questionnaire indicate a better outcome, reflecting higher happiness and life satisfaction levels.

    Measured: At the beginning of the study

  3. Assessing the positive and negative emotional states of the students participating in the study.

    The PANAS-GEN Questionnaire measures positive and negative expressions to provide insights into emotional states. It ranges from 1 to 5. Higher scores on positive expressions indicate a better outcome, reflecting higher positive emotions. Conversely, higher scores on negative expressions may suggest a less favorable outcome, indicating higher levels of negative emotions.

    Measured: At the beginning of the study

  4. Assessing the well-being of the students participating in the study.

    The RYFF Psychological Well-being Questionnaire assesses different aspects of psychological well-being among students. The RYFF Psychological Well-being Questionnaire typically ranges from 1 to 6. Higher scores on the RYFF Psychological Well-being Questionnaire indicate a better outcome, reflecting higher levels of psychological well-being.

    Measured: At the beginning of the study

  5. Assessing the overall life satisfaction levels of the students participating in the study.

    The Satisfaction with Life Questionnaire evaluates overall life satisfaction. It ranges from 1 to 7. Higher scores on the Satisfaction with Life Questionnaire indicate a better outcome and reflect higher levels of life satisfaction.

    Measured: At the beginning of the study

  6. Assessing the subjective happiness levels of the students participating in the study.

    The Subjective Happiness Scale assesses subjective happiness levels. It ranges from 1 to 7. Higher scores on the Subjective Happiness Scale indicate a better outcome, reflecting higher levels of subjective happiness.

    Measured: At the beginning of the study

  7. Assessing the sleep quality of the students participating in the study.

    The Pittsburgh Quality of Sleep Index (PSQI) evaluates the sleep quality of the participants. It ranges from 0 to 21. Lower scores on the PSQI indicate a better outcome, reflecting higher sleep quality.

    Measured: At the beginning of the study

  8. Assessing the worry and anxiety levels of the students participating in the study.

    The Penn State Worry Questionnaire (PSWQ) assesses students' worry and anxiety levels. It ranges from 1 to 5. Lower scores on the PSWQ indicate a better outcome, reflecting lower levels of worry and anxiety.

    Measured: At the beginning of the study

  9. Assessing the effects of the respiratory techniques program on the intrinsic and extrinsic motivation levels of the students participating in the study.

    Comparison of the MSLQ baseline scores before and after 14 weeks of the respiratory techniques program. Higher scores on intrinsic motivation indicate a better outcome, reflecting a higher level of internal motivation. Conversely, higher scores on extrinsic motivation may suggest a reliance on external rewards or pressures, which could indicate a less favorable outcome.

    Measured: 14 weeks after the beginning of the study

  10. Assessing the effects of the respiratory techniques program on the happiness levels of the students participating in the study.

    Comparison of the Oxford Happiness Questionnaire baseline scores before and after 14 weeks of the respiratory techniques program. Higher scores on the Oxford Happiness Questionnaire indicate a better outcome, reflecting higher happiness and life satisfaction levels.

    Measured: 14 weeks after the beginning of the study

  11. Assessing the effects of the respiratory techniques program on the students' positive and negative emotional states.

    Comparison of the PANAS-GEN Questionnaire baseline scores before and after 14 weeks of the respiratory techniques program. Higher scores on positive expressions indicate a better outcome, reflecting higher positive emotions. Conversely, higher scores on negative expressions may suggest a less favorable outcome, indicating higher levels of negative emotions.

    Measured: 14 weeks after the beginning of the study

  12. Assessing the effects of the respiratory techniques program on the students' well-being.

    Comparison of the RYFF Psychological Well-being Questionnaire baseline scores before and after 14 weeks of the respiratory techniques program. Higher scores on the RYFF Psychological Well-being Questionnaire indicate a better outcome, reflecting higher levels of psychological well-being.

    Measured: 14 weeks after the beginning of the study

  13. Assessing the effects of the respiratory techniques program on the overall life satisfaction levels of the students participating in the study.

    Comparison of the Satisfaction with Life Questionnaire baseline scores before and after 14 weeks of the respiratory techniques program. Higher scores on the Satisfaction with Life Questionnaire indicate a better outcome, reflecting higher levels of life satisfaction.

    Measured: 14 weeks after the beginning of the study

  14. Assessing the effects of the respiratory techniques program on the subjective happiness levels of the students participating in the study.

    Comparison of the Subjective Happiness Scale baseline scores before and after 14 weeks of the respiratory techniques program. Higher scores on the Subjective Happiness Scale indicate a better outcome, reflecting higher levels of subjective happiness.

    Measured: 14 weeks after the beginning of the study

  15. Assessing the effects of the respiratory techniques program on the quality of sleep of the students participating in the study.

    Comparison of the Pittsburgh Quality of Sleep Index (PSQI) baseline scores before and after 14 weeks of the respiratory techniques program. Lower scores on the PSQI indicate a better outcome, reflecting higher sleep quality.

    Measured: 14 weeks after the beginning of the study

  16. Assessing the effects of the respiratory techniques program on the worry and anxiety levels of the students participating in the study.

    Comparison of the Penn State Worry Questionnaire (PSWQ) baseline scores before and after 14 weeks of the respiratory techniques program. Lower scores on the PSWQ indicate a better outcome, reflecting lower levels of worry and anxiety

    Measured: 14 weeks after the beginning of the study

  17. Adherence to breathing exercises at 12-month follow-up

    Adherence will be assessed using a structured self-report questionnaire developed for this study. Key variables include: weekly frequency, session duration, technique used, barriers, and perceived utility. A composite dose index (frequency × duration) and binary adherence variable will be calculated. Full questionnaire, codebook, and scoring instructions are available at: https://doi.org/10.17605/OSF.IO/T9XAP

    Measured: 12 months after the end of the intervention

  18. Coping strategies assessed with the COPE at 12-month follow-up

    Coping will be measured using the COPE inventory (50-item version). The scale includes multiple subscales such as active coping, emotional support, denial, acceptance, planning, and others. Subscale scores will be computed according to the scoring manual.

    Measured: 12 months after the end of the intervention

  19. Self-esteem assessed with the Rosenberg Self-Esteem Scale at 12-month follow-up

    Self-esteem will be measured using the Rosenberg Self-Esteem Scale (RSES), a 10-item validated questionnaire. Higher total scores indicate higher self-esteem.

    Measured: 12 months after the end of the intervention

  20. Perceived psychological benefit of breathing practice at 12-month follow-up

    Psychological benefit will be evaluated using four Likert-scale items measuring perceived improvement in stress, sleep, positivity, and worry. A composite mean score will be calculated (Perceived_benefit_mean). Instrument details and scoring instructions are available at: https://doi.org/10.17605/OSF.IO/T9XAP

    Measured: 12 months after the end of the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2024
  2. Study start9 May 2024
  3. Primary completion29 Aug 2024
  4. Study completion30 Oct 2024

Resources

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
Screening
Allocation
Non-randomised
Intervention model
Factorial
Model description
This study uses a multiple-group design to investigate various psychosocial aspects of physical therapy students and to explore the potential benefits of breathing techniques as a well-being-promoting intervention. The study involves three groups: Intervention group: second-year physical therapy students participating in a 14-week breathing techniques program. Control group: second-year physical therapy students who do not participate in the program but complete the same questionnaires. Comparison groups: 1st, 2nd, and 3rd year physical therapy students participating in assessments only.
Masking
None (open label)
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06341569
Sponsor's protocol ID
11/07.03.2024
Status last verified
Aug 2025
First submitted
14 Mar 2024
Last updated
29 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Crisan AF, Pescaru CC, Maritescu A, Carunta V, Stoicescu ER, Oancea C, Amaricai E, Onofrei RR. A 14-week structured breathing program: an investigation into its impact on psychological health parameters in university students. BMC Public Health. 2025 Apr 14;25(1):1395. doi: 10.1186/s12889-025-22585-8.

    PubMed 40229773

Questions about this trial

What is this clinical trial studying?

A study testing Respiratory breathing techniques group in people with Anxiety State and Motivation, run by University of Medicine and Pharmacy "Victor Babes" Timisoara at 1 site in Romania.

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 1 inclusion and 3 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 29 Aug 2025. 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 Romania. 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?

Assessing intrinsic and extrinsic motivation levels among physical therapy students. (time frame: At the beginning of the study). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06341569, which also lists 1 linked publication.

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 29 Aug 2025.

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