StressRPGBREATH23NCT06308783
Diaphragmatic Breathing and Global Postural Reeducation on Stress and Sleep Quality in University Students
A study testing Diaphragmatic Breathing and Global Postural Reeducation in people with Stress and Sleep Disturbance, run by Universidad Francisco de Vitoria.
Trial summary
Introduction: Nowadays, the reduction of perceived stress and the improvement of sleep quality are considered fundamental aspects in the quality of life of both healthy subjects and patients with disease. Stress has become a pandemic in recent years due to the socio-labor demands faced by society. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Sleep Disturbance
- What is being tested?
- Diaphragmatic Breathing and Global Postural Reeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 5 May 2024to 18 Jul 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
- Healthy subjects over 18 years of age.
- Physiotherapy students of Francisco de Vitoria University.
- Ability to understand written and oral Spanish.
- Ability to communicate in Spanish or French.
Who cannot join
- < 18 years of age Cognitive disorders (psychiatric or mental).
- Problems when understanding instructions.
- Follow-up of a stress-focused treatment (medication, psychological therapy, meditation, etc.).
- Smokers.
- Pregnant women.
- Pathologies (rheumatic, neurological, cardiovascular, respiratory, visceral, tumor, fibromyalgia, physical handicap etc.).
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- Serious accident or recent surgery.
- Sleep disorders (apnea...).
- Practice of a daily exercise similar to the intervention (Pilates, Yoga, tai chi, qi gong, etc.).
- Not undergoing any other intervention during the investigation.
- Suffering from stress lower than 29/56 on the PSS14 questionnaire.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Diaphragmatic Breathing and Global Postural Reeducation on Stress and Sleep Quality in Healthy University Students
Introduction: Nowadays, the reduction of perceived stress and the improvement of sleep quality are considered fundamental aspects in the quality of life of both healthy subjects and patients with disease. Stress has become a pandemic in recent years due to the socio-labor demands faced by society. On the other hand, it has a direct relationship with the quality of sleep, its influence being bidirectional. In this regard, several tools have been reported for the management of these conditions. These include strategies such as yoga, mindfulness, diaphragmatic breathing (DR) or Pilates. On the other hand, other proposals such as global postural reeducation (GPR) lack evidence in the management of these conditions.
Objectives: Compare the effects of a diaphragmatic breathing self-management program with global postural reeducation on stress and sleep quality in university students.
Read more
Method: The study will be carried out with physiotherapy students of the University Francisco de Vitoria. The participants will be randomly divided into three groups: GPR group, DR group and control group. Perceived stress (Perceived Stress Scale - PSS14) and reported sleep quality (Pittsburgh Sleep Quality Index - PSQI) will be measured three times throughout the study: pre-intervention, 3 weeks after the start of the intervention and post-intervention. The intervention will last 6 weeks, during which time all participants will be required to complete the 5 Grade Scale (5GS) each morning. The GPR group will perform; Frog to the ground posture, while the DR group will follow a set breathing protocol at a 4/6 rhythm. Both GPR and DR will be performed 10 minutes before going to sleep.
Ethical considerations:
The principles of the 1964 Declaration of Helsinki will be followed. The proposed interventions are non-invasive, based on the combination of mild physical activity tools, body awareness and relaxation techniques.
The dependent variables to be measured are based on clinimetric aspects, without any harm to the participants.
Subjects will be asked to participate on a voluntary basis and may withdraw from the study at any time.
Read the detailed description
MATERIAL AND METHODS Type of study This work will be an analytical, experimental, longitudinal and prospective study, unblinded. The patients were randomly divided into 3 groups, one of which was a control group.
This study will be conducted in accordance with the 1964 Helsinki declaration.
Sample The target population of the study will be university students who suffer from stress. The accessible population will be physiotherapy students of the Francisco de Vitoria University.
Method of selection and assignment of participants to each group Before selecting our sample, we will divide the future participants into different groups with simple randomization.
To obtain the sample we will go through the physiotherapy classes of the UFV, explaining our project and providing each person with a QR code.
There will be a control group and two experimental groups (global posture reeducation and diaphragmatic breathing). The participants will not know which group they belong to until the day of the start of the intervention.
Variables
The independent variables of the study are:
- Global posture reeducation
- Diaphragmatic breathing
The dependent variables are:
- Stress
- Quality of sleep
Tools and measurements Stress The level of stress will be measured before and after the intervention using a validated questionnaire both in its original format and in its Spanish format.
Sleep quality To assess and measure the participants; sleep quality, we will use a questionnaire. The Pittsburgh Sleep Quality Index (PSQI) is the most commonly used tool in clinical and research to assess sleep quality. It proven valid, as well as its translation into Spanish.
- Conditions
- Stress, Sleep Disturbance
- Being tested
- Diaphragmatic Breathing, Global Postural Reeducation
- Keywords
- diaphragmatic breathing, global posture reeducation, stress, sleep quality
- Medical subject headings
- Parasomnias, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic BreathingOther
10 minutes each day during 6 weeks, before sleeping.
Global Postural ReeducationOther
Also called GPR
10 minutes each day during 6 weeks, before sleeping.
| Study group | Role | What they receive |
|---|---|---|
| Diaphragmatic Breathing | Experimental | Diaphragmatic breathing, also known as deep breathing, is based on breathing slowly and widely, expanding the abdomen and then the ribs on inspiration and emptying as much air as possible on exhalation. Receives: Other: Diaphragmatic Breathing |
| Global Postural Reeducation | Experimental | Global Postural Re-education (GPR) is a technique described by Philippe Souchard that is based on the active and sustained stretching of muscle chains by performing specific postures. Breathing plays a fundamental role in the development of exercise, influencing the structures of the body and its functioning. Receives: Other: Global Postural Reeducation |
| Control Group | No intervention | No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress
Perceived Stress Scale Questionnaire
Measured: First measure one day before starting the intervention, second measure 3 weeks after starting the intervention and third measure 6 weeks after starting the intervention (last day of intervention)
Sleep Quality
Pittsburgh Sleep Quality Index Questionnaire
Measured: First measure one day before starting the intervention, second measure 3 weeks after starting the intervention and third measure 6 weeks after starting the intervention (last day of intervention)
Secondary outcomes (1)
Sleep Quality
5 Grade Scale
Measured: Up to 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start5 May 2024 (estimated)
- Primary completion17 Jul 2024 (estimated)
- Study completion18 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group receives Diaphragmatic Breathing, one group receives Global Postural Reeducation, and the other group receives no intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Francisco de Vitoria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alberto Roldán Ruiz, PhD, Principal investigator, Universidad Francisco de Vitoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308783
- Sponsor's protocol ID
- UFranciscoVitoriaRPGBREATH23
- Acronym
- RPGBREATH23
- Status last verified
- Dec 2023
- First submitted
- 5 Feb 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hopper SI, Murray SL, Ferrara LR, Singleton JK. Effectiveness of diaphragmatic breathing for reducing physiological and psychological stress in adults: a quantitative systematic review. JBI Database System Rev Implement Rep. 2019 Sep;17(9):1855-1876. doi: 10.11124/JBISRIR-2017-003848.
PubMed 31436595Ferreira GE, Barreto RG, Robinson CC, Plentz RD, Silva MF. Global Postural Reeducation for patients with musculoskeletal conditions: a systematic review of randomized controlled trials. Braz J Phys Ther. 2016 Apr 1;20(3):194-205. doi: 10.1590/bjpt-rbf.2014.0153.
PubMed 27437710
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Diaphragmatic Breathing and Global Postural Reeducation on Stress and Sleep Quality in Healthy University Students
- ClinicalTrials.gov ID
- NCT06308783
- Acronym / sponsor ID
- RPGBREATH23 / UFranciscoVitoriaRPGBREATH23
- Conditions
- Stress, Sleep Disturbance
- Keywords
- diaphragmatic breathing, global posture reeducation, stress, sleep quality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Universidad Francisco de VitoriaUniversity, hospital or other
- Study start
- 5 May 2024 (estimated)
- Primary completion
- 17 Jul 2024 (estimated)
- Study completion
- 18 Jul 2024 (estimated)
- First posted
- 13 Mar 2024 (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.
Introduction: Nowadays, the reduction of perceived stress and the improvement of sleep quality are considered fundamental aspects in the quality of life of both healthy subjects and patients with disease. Stress has become a pandemic in recent years due to the socio-labor demands faced by society. On the other hand, it has a direct relationship with the quality of sleep, its influence being bidirectional. In this regard, several tools have been reported for the management of these conditions. These include strategies such as yoga, mindfulness, diaphragmatic breathing (DR) or Pilates. On the other hand, other proposals such as global postural reeducation (GPR) lack evidence in the management of these conditions.
Objectives: Compare the effects of a diaphragmatic breathing self-management program with global postural reeducation on stress and sleep quality in university students.
Method: The study will be carried out with physiotherapy students of the University Francisco de Vitoria. The participants will be randomly divided into three groups: GPR group, DR group and control group. Perceived stress (Perceived Stress Scale - PSS14) and reported sleep quality (Pittsburgh Sleep Quality Index - PSQI) will be measured three times throughout the study: pre-intervention, 3 weeks after the start of the intervention and post-intervention. The intervention will last 6 weeks, during which time all participants will be required to complete the 5 Grade Scale (5GS) each morning. The GPR group will perform; Frog to the ground posture, while the DR group will follow a set breathing protocol at a 4/6 rhythm. Both GPR and DR will be performed 10 minutes before going to sleep.
Ethical considerations:
The principles of the 1964 Declaration of Helsinki will be followed. The proposed interventions are non-invasive, based on the combination of mild physical activity tools, body awareness and relaxation techniques.
The dependent variables to be measured are based on clinimetric aspects, without any harm to the participants.
Subjects will be asked to participate on a voluntary basis and may withdraw from the study at any time.
Detailed description
MATERIAL AND METHODS Type of study This work will be an analytical, experimental, longitudinal and prospective study, unblinded. The patients were randomly divided into 3 groups, one of which was a control group.
This study will be conducted in accordance with the 1964 Helsinki declaration.
Sample The target population of the study will be university students who suffer from stress. The accessible population will be physiotherapy students of the Francisco de Vitoria University.
Method of selection and assignment of participants to each group Before selecting our sample, we will divide the future participants into different groups with simple randomization.
To obtain the sample we will go through the physiotherapy classes of the UFV, explaining our project and providing each person with a QR code.
There will be a control group and two experimental groups (global posture reeducation and diaphragmatic breathing). The participants will not know which group they belong to until the day of the start of the intervention.
Variables
The independent variables of the study are:
- Global posture reeducation
- Diaphragmatic breathing
The dependent variables are:
- Stress
- Quality of sleep
Tools and measurements Stress The level of stress will be measured before and after the intervention using a validated questionnaire both in its original format and in its Spanish format.
Sleep quality To assess and measure the participants; sleep quality, we will use a questionnaire. The Pittsburgh Sleep Quality Index (PSQI) is the most commonly used tool in clinical and research to assess sleep quality. It proven valid, as well as its translation into Spanish.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- One group receives Diaphragmatic Breathing, one group receives Global Postural Reeducation, and the other group receives no intervention.
| Arm | Type | Receives |
|---|---|---|
| Diaphragmatic Breathing | Experimental | Other: Diaphragmatic BreathingDiaphragmatic breathing, also known as deep breathing, is based on breathing slowly and widely, expanding the abdomen and then the ribs on inspiration and emptying as much air as possible on exhalation. |
| Global Postural Reeducation | Experimental | Other: Global Postural ReeducationGlobal Postural Re-education (GPR) is a technique described by Philippe Souchard that is based on the active and sustained stretching of muscle chains by performing specific postures. Breathing plays a fundamental role in the development of exercise, influencing the structures of the body and its functioning. |
| Control Group | No intervention | –No treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy subjects over 18 years of age.
- Physiotherapy students of Francisco de Vitoria University.
- Ability to understand written and oral Spanish.
- Ability to communicate in Spanish or French.
Key exclusion criteria (11 listed)
- < 18 years of age Cognitive disorders (psychiatric or mental).
- Problems when understanding instructions.
- Follow-up of a stress-focused treatment (medication, psychological therapy, meditation, etc.).
- Smokers.
- Pregnant women.
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 |
|---|---|---|
| Diaphragmatic Breathing10 minutes each day during 6 weeks, before sleeping. | Other | Diaphragmatic Breathing |
| Global Postural ReeducationAlso: GPR10 minutes each day during 6 weeks, before sleeping. | Other | Global Postural Reeducation |
Primary outcome
Stress
Time frame: First measure one day before starting the intervention, second measure 3 weeks after starting the intervention and third measure 6 weeks after starting the intervention (last day of intervention)
Perceived Stress Scale Questionnaire
Sleep Quality
Time frame: First measure one day before starting the intervention, second measure 3 weeks after starting the intervention and third measure 6 weeks after starting the intervention (last day of intervention)
Pittsburgh Sleep Quality Index Questionnaire
1 secondary outcome
Sleep Quality
Time frame: Up to 6 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Results publication: PubMed 31436595Hopper SI, Murray SL, Ferrara LR, Singleton JK. Effectiveness of diaphragmatic breathing for reducing physiological and psychological stress in adults: a quantitative systematic review. JBI Database System Rev Implement Rep. 2019 Sep;17(9):1855-1876. doi: 10.11124/JBISRIR-2017-003848.
- Results publication: PubMed 27437710Ferreira GE, Barreto RG, Robinson CC, Plentz RD, Silva MF. Global Postural Reeducation for patients with musculoskeletal conditions: a systematic review of randomized controlled trials. Braz J Phys Ther. 2016 Apr 1;20(3):194-205. doi: 10.1590/bjpt-rbf.2014.0153.
- 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.
Alberto Roldán Ruiz, PhD principal investigator
Universidad Francisco de Vitoria
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic Breathing and Global Postural Reeducation in people with Stress and Sleep Disturbance, run by Universidad Francisco de Vitoria.
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 11 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: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alberto Roldán Ruiz, PhD (+34657608266, alberto.roldan@ufv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress (time frame: First measure one day before starting the intervention, second measure 3 weeks after starting the intervention and third measure 6 weeks after starting the intervention (last day of intervention)). The study lists 2 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 NCT06308783, which also lists 2 linked publications.
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 13 Mar 2024.