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Influence of an Osteopathic Treatment Protocol on the Improvement of Sleep Quality in Young Adults With Insomnia

Study of the Influence of an Osteopathic Treatment Protocol on the Improvement of Sleep: a Double-blind Randomized Controlled Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05899972
Enrollment
50
Registered
2023-06-12
Start date
2024-09-01
Completion date
2024-12-31
Last updated
2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Osteopathy, Insomnia, Sleep disorder

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. Insomnia is a sleep disorder defined by difficulty falling asleep, staying asleep, or both. It can cause significant distress and impair daily tasks. The symptoms of insomnia are expressed by having difficulty falling asleep, waking up frequently during the night, waking up very early on a daily basis, and tiredness already present upon waking up. Osteopathic treatment results in vasodilation, muscle relaxation and increased blood flow, resulting in improved range of motion, decreased pain perception and/or tissue changes (Henley, Ivins, Mills, Wen, & Benjamin, 2008). Thus, osteopathy ensures improved physical and mental health, which consequently helps patients with their sleep disorders.

Interventions

With the volunteer in a supine position, the researcher placed the palms of their hands on the patient's shoulders. The contact is made with the hands on the shoulder blades of the volunteer for 6 minutes.

With the volunteer in a supine position, the investigator is sitting position at the patient's bedside. The investigator starts by placing both hands under the patient's head in the occipital region. After palpating the suboccipital muscles, the investigator uses the second, third and fourth fingers of both hands flexed against the muscle belly and remains in this position.

OTHERFrontal lift technique

With the volunteer in a supine position, the investigator is sitting position at the patient's bedside. The investigator positions the tips of both index fingers on either side of the metopic suture while the third finger remains resting on the frontal bone so that the tips of the fourth fingers contact the zygomatic processes bilaterally. A slight pressure is applied with the index fingers and an anterior pressure is performed.

OTHERParietal lift technique

With the volunteer in a supine position, the investigator is sitting position at the patient's bedside. The investigator places the palms on the lateral edges of the parietal bones and the thumbs crossed at the sagittal suture. First, a medial pressure is administered with the second, third and fourth fingers and then a cephalic traction is performed.

OTHERIV ventricle technique

With the volunteer in a supine position, the investigator is sitting position at the patient's bedside. The investigator positions his hands in a shell and thumbs together at the level of the spinous apophyses of the patient's second or third cervical vertebra.

Sponsors

Escola Superior de Tecnologia da Saúde do Porto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, 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

Sex/Gender
ALL
Age
18 Years to 30 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in Sleep Quality assessed with the Pittsburgh Sleep Quality Index7 days post-interventionThe Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality, measures several different aspects of sleep.

Countries

Portugal

Contacts

Primary ContactNatália MO Campelo, PhD
ncampelo.estsp.ipp@gmail.com938674365

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026