Physical Therapy Students: Well-being

NCT06341569 | Completed

• 1 other identifier: 11/07.03.2024
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anxiety State; Motivation; Life Stress; Sleep, Inadequate

Keywords

Students; Physical Therapy; Anxiety; Motivation; Happiness; Breathing techniques

Outcome Measures

Primary Outcomes (20)

• 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.

  At the beginning of the study

• 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.

  At the beginning of the study

• 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.

  At the beginning of the study

• 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.

  At the beginning of the study

• 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.

  At the beginning of the study

• 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.

  At the beginning of the study

• 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.

  At the beginning of the study

• 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.

  At the beginning of the study

• 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.

  14 weeks after the beginning of the study

• 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.

  14 weeks after the beginning of the study

• 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.

  14 weeks after the beginning of the study

• 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.

  14 weeks after the beginning of the study

• 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.

  14 weeks after the beginning of the study

• 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.

  14 weeks after the beginning of the study

• 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.

  14 weeks after the beginning of the study

• 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

  14 weeks after the beginning of the study

• 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

  12 months after the end of the intervention

• 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.

  12 months after the end of the intervention

• 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.

  12 months after the end of the intervention

• 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

  12 months after the end of the intervention

Study Arms (2)

Respiratory breathing techniques group

EXPERIMENTAL

Subjects 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.

Other: Respiratory breathing techniques group

Control group

NO INTERVENTION

Second-year physical therapy students that do not want to participate in the breathing technique program and will complete only the questionnaires.

Interventions

Respiratory breathing techniques group OTHER

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.

Respiratory breathing techniques group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Medicine and Pharmacy "Victor Babes" Timisoara: lead

Study Sites (1)

University of Medicine and Pharmacy Victor Babes Timisoara

Timișoara, Timiș County, 3003001, Romania

Location

Related Publications (1)

• 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.

  PMID: 40229773 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Stress, Psychological; Sleep Deprivation

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexandru Florian Crisan, PhD

  University of Medicine and Pharmacy "Victor Babes" Timisoara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: April 2, 2024
• Study Start: May 9, 2024
• Primary Completion: August 29, 2024
• Study Completion: October 30, 2024
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

RO (1)