NCT05488015

Brief Summary

Stress is a physiological reaction of our organism to situations that are perceived as threats. Of the different types of stress, emotional stress understood as a feeling of tension in difficult and unmanageable situations is increasingly prevalent in the western population and is responsible for a multitude of physical and psychological health disorders. In the same vein, sleep is a process experienced with a circadian (daily) periodicity in which there is a direct detachment from the environment and is necessary to maintain physiological, psychological and/or behavioral activities correctly. Both teachers and students in higher education are examples of populations in which emotional stress and problems related to sleep quality have been described, with women being more sensitive to these problems. The beneficial effects of physical exercise on different cognitive variables have been described, and it has been possible to characterise these effects on the physiological triggers of stress and sleep and, therefore, on alterations in the nervous and hormonal systems. Along these lines, Global Postural Re-education (GPR) is a physical therapy designed to re-establish the coordination of muscle chains and relieve pain. It has been established that GPR is a therapy in which the active participation of the patient is necessary so that it can be framed as physical exercise, with a structured execution protocol. The overall aim of this study is to test whether a self-treatment therapy with RPG, after a learning and familiarisation phase, performed for 8 weeks, can have positive effects on stress reduction and improvement of sleep quality in female teachers and students of health sciences.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

August 10, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2022

Completed
Last Updated

October 26, 2022

Status Verified

August 1, 2022

Enrollment Period

2 months

First QC Date

August 2, 2022

Last Update Submit

October 25, 2022

Conditions

Keywords

CortisolSleep qualitystudentslecturersself-treatment

Outcome Measures

Primary Outcomes (4)

  • Cortisol

    Cortisol concentrations are measured by saliva swab in the study patients.

    Changes along the day from wake-up to time to bed during 8 weeks

  • State-Trait Anxiety Inventory Trait (STAI-T)

    Anxiety is one of the most frequent emotional reactions caused by stress. Anxiety has been used to measure stress levels through the State and Trait Anxiety Questionnaire (STAI).The range of possible scores for the STAI varies from a minimum score of 20 to a maximum score of 80 on both the STAI-T and STAI-S subscales. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).

    At the beginning of procedure and at the end (8 weeks)

  • State-Trait Anxiety Inventory State (STAI-S)

    Anxiety is one of the most frequent emotional reactions caused by stress. Anxiety has been used to measure stress levels through the State and Trait Anxiety Questionnaire (STAI). The range of possible scores for the STAI varies from a minimum score of 20 to a maximum score of 80 on both the STAI-T and STAI-S subscales. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).

    At the beginning of procedure and at the end (8 weeks)

  • Pittsburgh Sleep Quality Index (PSQI)

    The PSQ1 is a validated questionnaire consisting of 19 self-assessed items plus 5 items assessed by the bed partner or roommate. It provides information on 7 sleep-related aspects: subjective sleep quality, sleep latency, sleep time duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, daytime dysfunction. The first 4 questions are answered concretely, and the following questions can be scored on a 4-point scale (0-3).

    At the beginning of procedure and at the end (8 weeks)

Secondary Outcomes (6)

  • Wakefulness After the Onset of Sleep (WASO)

    At the beginning of procedure and at the end (8 weeks)

  • Sleep efficiency (SE)

    At the beginning of procedure and at the end (8 weeks)

  • Total Sleep Time (TST)

    At the beginning of procedure and at the end (8 weeks)

  • Sleep Onset Latency (SOL)

    At the beginning of procedure and at the end (8 weeks)

  • Awakenings

    At the beginning of procedure and at the end (8 weeks)

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

1 week of familiarisation through videos, audios and information documents, followed by 8 weeks of self-treatment with two GPR postures.

Other: Global Postural Re-education (GPR)

Control

ACTIVE COMPARATOR

No change in lifestyle habits during the 8-week trial.

Other: Lifestyle habits

Interventions

GPR intervention lasted 8 weeks. Each week the postures had to be performed on 4 or 5 days.

Also known as: GPR
Intervention

No change in lifestyle habits during the 8-week trial.

Also known as: Normal life
Control

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • Age 18-45 years
  • Health sciences students and teachers.

You may not qualify if:

  • Rotating work shifts
  • Pregnant
  • Use of medications (Non-steroidal anti-inflammatory drugs (NSAIDs)
  • Acute or subacute back pain
  • Musculoskeletal and neurological injuries associated with sleep disorders
  • Sleep disorders (sleep apnea, circadian rhythm sleep disorder)
  • Tumor, rheumatological, adrenal or pituitary diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

David Varillas Delgado

Pozuelo de Alarcón, Madrid, 28224, Spain

Location

Related Publications (1)

  • Rodriguez-Aragon M, Varillas-Delgado D, Gordo-Herrera J, Fernandez-Ezequiel A, Moreno-Heredero B, Valle N. Effects of global postural re-education on stress and sleep quality in health sciences female students: a randomized controlled trial pilot study. Front Psychiatry. 2024 Aug 28;15:1404544. doi: 10.3389/fpsyt.2024.1404544. eCollection 2024.

MeSH Terms

Conditions

Stress, PsychologicalSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • David Varillas Delgado, PhD

    Universidad Francisco de Vitoria, crta Pozuelo-Majadahonda km 1.800 PC 28223, Madrid, Spain

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor responsible for collecting the results was blinded, without commenting on the group from which the patient came.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2022

First Posted

August 4, 2022

Study Start

August 10, 2022

Primary Completion

October 10, 2022

Study Completion

October 20, 2022

Last Updated

October 26, 2022

Record last verified: 2022-08

Locations