Study of the Influence of an Osteopathic Treatment Protocol on the Improvement of Sleep: a Double-blind Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change from baseline in Sleep Quality assessed with the Pittsburgh Sleep Quality Index
Study Overview
Brief Summary
Sleep deprivation, which is a universal necessity, has serious physiological consequences.
Sleep disorders are among the most common health problems, and yet they are often neglected. The osteopathic treatment results in vasodilation, muscle relaxation and increased blood flow, resulting in improved range of motion, decreased pain perception and/or tissue changes. Thus, osteopathy ensures improved physical and mental health, which consequently helps patients with their sleep disorders.
Detailed Description
Humans spend about a third of their lives sleeping, but most individuals know little about sleep. Sleep deprivation, which is a universal necessity, has serious physiological consequences.
Based on behavioral and physiological criteria, human sleep is divided into two phases: Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM).
NREM sleep corresponds to 75% to 80% of sleep and REM approximately 20% to 25% of sleep, existing between four to six episodes.
Sleep disorders are among the most common health problems, and yet they are often neglected. It is estimated that millions of people suffer chronically from a sleep or wakefulness disorder, impairing their health and longevity.
According to the International Classification of Sleep Disorders (ICSD) there are eight categories of sleep disorders and clinical history is essential for diagnosis, including family history, medical, psychiatric, neurological or substance abuse disorders.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
In the distribution of the volunteers to the groups, the participants chose between two numbered envelopes, opaque and sealed, in order to guarantee the confidentiality of the allocation, to which group they belonged. Inside each envelope is a piece of paper with the group, control group or intervention group.
Eligibility Criteria
- Ages
- 18 Years to 30 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Have sleep disorders (insomnia);
- •Volunteers between 18 and 30 years of age.
Exclusion Criteria
- •Attending the 3rd or 4th year of the Osteopathy Course;
- •Present fever (axillary or oral temperature higher than 37.5º C);
- •Have a history of skull fracture;
- •Have a history of bleeding and intracranial hemorrhage;
- •Have a diagnosis of convulsion.
Arms & Interventions
Experimental: Experimental group
The protocol is initiated by the suboccipital inhibition technique, with an average duration of three minutes. Afterwards, the frontal lift and parietal lift techniques were performed, which lasted an average of five minutes, being two and a half minutes for each one. Finally, the IV ventricle technique was performed, with an average duration of three minutes.
Intervention: Suboccipital inhibition technique (Other)
Experimental: Experimental group
The protocol is initiated by the suboccipital inhibition technique, with an average duration of three minutes. Afterwards, the frontal lift and parietal lift techniques were performed, which lasted an average of five minutes, being two and a half minutes for each one. Finally, the IV ventricle technique was performed, with an average duration of three minutes.
Intervention: Frontal lift technique (Other)
Experimental: Experimental group
The protocol is initiated by the suboccipital inhibition technique, with an average duration of three minutes. Afterwards, the frontal lift and parietal lift techniques were performed, which lasted an average of five minutes, being two and a half minutes for each one. Finally, the IV ventricle technique was performed, with an average duration of three minutes.
Intervention: Parietal lift technique (Other)
Experimental: Experimental group
The protocol is initiated by the suboccipital inhibition technique, with an average duration of three minutes. Afterwards, the frontal lift and parietal lift techniques were performed, which lasted an average of five minutes, being two and a half minutes for each one. Finally, the IV ventricle technique was performed, with an average duration of three minutes.
Intervention: IV ventricle technique (Other)
Control group
For the control group the placebo technique will be applied for 6 minutes.
Intervention: Placebo technique (Other)
Outcomes
Primary Outcomes
Change from baseline in Sleep Quality assessed with the Pittsburgh Sleep Quality Index
Time Frame: 7 days post-intervention
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality, measures several different aspects of sleep.
Secondary Outcomes
No secondary outcomes reported
Investigators
Natália Maria Oliveira Campelo
Professor
Escola Superior de Tecnologia da Saúde do Porto