Applying an Osteopathic Intervention to Improve Mental Health Symptoms: a Mixed-methods Feasibility Study Protocol.
NCT ID: NCT05674071
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2022-12-20
2023-08-01
Brief Summary
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Detailed Description
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Methods and analysis: This study will be an explanatory mixed-methods design. Participants will be 30 adults who have mild to moderate mental health symptoms and not experiencing any issues with pain. The feasibility and acceptability of the interventions will be the first primary outcome. Secondary outcomes will be physiological measures including heart rate variability (HRV), interoceptive accuracy (IAc) and blood pressure (BP). Psychological outcomes will also be measured by standardised questionnaires. These are being collected pre-and post-intervention. Additional outcomes will include recruitment rates and any adverse events that occur during the study. Participants will be randomised to one of four interventions. These are: high-velocity and articulation techniques (HVAT), soft-tissue massage (STM), craniosacral therapy (CST), and a combination of these three approaches. Participants will be interviewed about their experiences of the study and interventions to aid in assessing the feasibility and acceptability.
Discussion: This study will assess the feasibility and acceptability of conducting osteopathic interventions for improving mental health outcomes. These results from this will help to inform the running of a future randomised controlled trial. The study will also be producing original data which could provide preliminary evidence whether osteopathic approaches are of benefit to individual's mental health, even if they are pain-free.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Articulation/HVT
This intervention will use articulation and high-velocity thrust techniques
Articulation/HVT
Osteopathy 1
Soft-tissue massage
This intervention will use soft-tissue massage
Soft-tissue massage
Osteopathy 2
Craniosacral techniques
This intervention will use craniosacral techniques
Craniosacral techniques
Osteopathy 3
Combination
This intervention will use a combination of the three interventions: HVT, soft-tissue and craniosacral
Combination of the three interventions: HVT, soft-tissue and craniosacral techniques
This intervention will use a combination of the three interventions: HVT, soft-tissue and craniosacral techniques
Interventions
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Articulation/HVT
Osteopathy 1
Soft-tissue massage
Osteopathy 2
Craniosacral techniques
Osteopathy 3
Combination of the three interventions: HVT, soft-tissue and craniosacral techniques
This intervention will use a combination of the three interventions: HVT, soft-tissue and craniosacral techniques
Eligibility Criteria
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Inclusion Criteria
* Ability to read/write English.
Exclusion Criteria
* acute or chronic pain
18 Years
ALL
No
Sponsors
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Osteopathic Foundation
UNKNOWN
University College of Osteopathy
OTHER
Swansea University
OTHER
Responsible Party
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Darren Edwards
Principle Investigator
Principal Investigators
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Darren Edwards, PhD
Role: PRINCIPAL_INVESTIGATOR
Swansea University
Locations
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Swansea University
Swansea, Select State, United Kingdom
Countries
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References
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Hope-Bell J, Draper-Rodi J, Edwards DJ. Applying an osteopathic intervention to improve mild to moderate mental health symptoms: a mixed-methods feasibility randomised trial. Chiropr Man Therap. 2024 Nov 6;32(1):32. doi: 10.1186/s12998-024-00556-x.
Hope-Bell J, Draper-Rodi J, Edwards DJ. Applying an osteopathic intervention to improve mild to moderate mental health symptoms: a mixed-methods feasibility study protocol. BMJ Open. 2023 Jun 27;13(6):e071680. doi: 10.1136/bmjopen-2023-071680.
Other Identifiers
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DEdwardsOsteopathy
Identifier Type: -
Identifier Source: org_study_id