- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06308783
Diaphragmatic Breathing and Global Postural Reeducation on Stress and Sleep Quality in University Students (RPGBREATH23)
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alberto Roldán Ruiz, PhD
- Phone Number: +34657608266
- Email: alberto.roldan@ufv.es
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- < 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.).
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
No treatment
|
|
Experimental: Diaphragmatic Breathing
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.
|
10 minutes each day during 6 weeks, before sleeping.
|
Experimental: Global Postural Reeducation
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.
|
10 minutes each day during 6 weeks, before sleeping.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep Quality
Time Frame: Up to 6 weeks.
|
5 Grade Scale
|
Up to 6 weeks.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alberto Roldán Ruiz, PhD, Universidad Francisco de Vitoria
Publications and helpful links
General 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.
- Ferreira 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UFranciscoVitoriaRPGBREATH23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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