Osteopathic Sympathetic Harmonization and Depression

Not Applicable

Completed

• Conditions: Osteopathic Manipulative Treatment
• Interventions: Other: Osteopathic sympathic harmonization; Other: Sham intervention

• Registration Number: NCT04840043
• Lead Sponsor: Cumhuriyet University

Brief Summary

Depression appears to be resistant to the available pharmacological treatments. Autonomic responses accompanied by any psychological stress are sympathetic nervous system (SNS) and neuroendocrine responses are formed by hypothalamus-pituitary-adrenal (HPA) axis. The purpose of this study is; assessment of effectiveness of osteopathic approach on sympathetic nervous system and HPA axis in adolescents with depression.

Detailed Description

Depression diagnosed and volunteer to participate 39 cases who between the ages of 15-21 included. All participants were recruited and randomly assigned into two groups, the osteopathy group (OG) and the placebo group (PG). Stimulation on the sympathetic truncus and prevertebral ganglia were performed in the OG group. The stimulation of the PG group was performed with a lighter touch and a shorter duration in similar areas. Each participant was filled in the demographic data form, Beck Depression Scale and State and Trait Anxiety Inventory (STAI Form - 1 and Form - 2) before the application. Emotional state visual analog scale and STAI Form - 1 was filled and blood pressure and pulse measurement were made and saliva sample was taken before application, immediately after application and 20 minutes after application.

Study Timeline

• Study Start: 2017-10-11
• Primary Completion: 2018-03-23
• Study Completion: 2018-06-05
• Status Verified: 2021-04
• Study First Submitted: 2021-04-04
• Study First Submitted QC: 2021-04-07
• Last Update Submitted: 2021-04-07
• Study First Posted: 2021-04-09
• Last Update Posted: 2021-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• To be diagnosed with clinical depression by a psychiatrist according to The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria
• Volunteering to participate in the study

Exclusion Criteria

• Fever over 38.5
• Acute injury or infection
• Rib fracture
• Cardiac arrhythmia
• Using drugs that affect cortisol levels (oral contraceptives, hormonal drugs, antidepressants, antipsychotics etc.)
• Being pregnant, premenstrual or in the menstrual period for female participants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Osteopathy Group	Osteopathic sympathic harmonization	Stimulation on the sympathetic truncus and prevertebral ganglia
Control Group	Sham intervention	Stimulation on similar areas with lighter touch and shorter duration

Primary Outcome Measures

Name	Time	Method
Change from Baseline Salivary Biomarkers at 20 minutes	Before intervention, immediately after the intervention, 20 second after the intervention	Salivary a-amylase and cortisol levels were measured for each sample. These biomarkers were analysed Enzyme-Linked Immunosorbent Assay.
The Beck Depression Inventory (BDI)	Before intervention	The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.
Demographic data	Before intervention	Height (m); weight (kg); body mass index (kg/m2)
Change from Baseline Heart rate and blood pressure measurements at 20 minutes	Before intervention, immediately after the intervention, 20 minutes after the intervention	Heart rate (beats per minute) and blood pressure (mm/Hg) were measured with automatic blood pressure monitor (the Microlife BP 3BT0-A). It is a clinically validated and 1-star automatic blood pressure monitor
The State-Trait Anxiety Inventory (STAI) Form - 1	Before intervention	The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. It also is often used in research as an indicator of caregiver distress.
Change from Baseline The State-Trait Anxiety Inventory (STAI) Form - 2 at 20 minutes	Before intervention, immediately after the intervention, 20 minutes after the intervention	The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. It also is often used in research as an indicator of caregiver distress.

Trial Locations

Locations (1)

Sivas Cumhuriyet University; 🇹🇷 Si̇vas, Turkey