NCT06308783

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

February 5, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 13, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

May 5, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2024

Completed
Last Updated

March 13, 2024

Status Verified

December 1, 2023

Enrollment Period

2 months

First QC Date

February 5, 2024

Last Update Submit

March 12, 2024

Conditions

Keywords

diaphragmatic breathingglobal posture reeducationstresssleep quality

Outcome Measures

Primary Outcomes (2)

  • Stress

    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

    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 Outcomes (1)

  • Sleep Quality

    Up to 6 weeks.

Study Arms (3)

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.

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.

Other: Global Postural Reeducation

Control Group

NO INTERVENTION

No treatment

Interventions

10 minutes each day during 6 weeks, before sleeping.

Diaphragmatic Breathing

10 minutes each day during 6 weeks, before sleeping.

Also known as: GPR
Global Postural Reeducation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \< 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

MeSH Terms

Conditions

ParasomniasSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental DisordersSleep Disorders, IntrinsicDyssomnias

Study Officials

  • Alberto Roldán Ruiz, PhD

    Universidad Francisco de Vitoria

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alberto Roldán Ruiz, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: One group receives Diaphragmatic Breathing, one group receives Global Postural Reeducation, and the other group receives no intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2024

First Posted

March 13, 2024

Study Start

May 5, 2024

Primary Completion

July 17, 2024

Study Completion

July 18, 2024

Last Updated

March 13, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share