Positive Communication (Primary)NCT03855254
Psychological Context Effects
A study testing communication type in people with Positive Communication (Primary) and Negative Communication, run by Swansea University at 1 site in United Kingdom.
Trial summary
This study explores how contextual effects in the fore of positive and negative communication can affect the effect of an osteopathic technique on pain pressure thresholds. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Positive Communication (Primary), Negative Communication, Control Condition
- What is being tested?
- communication type
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2018to 10 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Health volunteers with no forms of existing pain.
Who cannot join
- Participants with existing pain.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychological Context Effects of Participant Expectation on Pain Pressure Thresholds Following Cervicothoracic HVLA Thrust Manipulation: A Double Blind, Crossover, Randomised Controlled Trial
This study explores how contextual effects in the fore of positive and negative communication can affect the effect of an osteopathic technique on pain pressure thresholds.
- Being tested
- communication type
- Keywords
- Contextual effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
communication typeBehavioural
Also called Positive communication, Negative communication, Control
Positive and negative communication types are the way that the practitioner communicates to the participant about the potential effectiveness of the osteopathic treatment. The control is a neutral communication condition.
| Study group | Role | What they receive |
|---|---|---|
| Positive communication | Experimental | Not described Receives: Behavioral: communication type |
| Control (neutral communication) | No intervention | Not described |
| Negative communication | Experimental | Not described Receives: Behavioral: communication type |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain pressure threshold
This is the degree to which the participant can tolerate pressure induced through an algometer.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start1 Sep 2018
- Primary completion5 Dec 2018
- Study completion10 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Positive Communication (Primary)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swansea University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darren Edwards, Swansea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855254
- Sponsor's protocol ID
- SwanseaU1
- Status last verified
- Feb 2019
- First submitted
- 21 Feb 2019
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Participant data may be sheared to other researcher on request.
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Context Effects of Participant Expectation on Pain Pressure Thresholds Following Cervicothoracic HVLA Thrust Manipulation: A Double Blind, Crossover, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03855254
- Acronym / sponsor ID
- SwanseaU1
- Keywords
- Contextual effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Swansea UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 5 Dec 2018 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 26 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study explores how contextual effects in the fore of positive and negative communication can affect the effect of an osteopathic technique on pain pressure thresholds.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Positive communication | Experimental | Behavioral: communication type |
| Control (neutral communication) | No intervention | – |
| Negative communication | Experimental | Behavioral: communication type |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Health volunteers with no forms of existing pain.
Key exclusion criteria (1 listed)
- Participants with existing pain.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| communication typeAlso: Positive communication, Negative communication, ControlPositive and negative communication types are the way that the practitioner communicates to the participant about the potential effectiveness of the osteopathic treatment. The control is a neutral communication condition. | Behavioural | Negative communication, Positive communication |
Primary outcome
Pain pressure threshold
Time frame: 6 months
This is the degree to which the participant can tolerate pressure induced through an algometer.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Individual participant dataSharing planned: Undecided. Participant data may be sheared to other researcher on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing communication type in people with Positive Communication (Primary) and Negative Communication, run by Swansea University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain pressure threshold (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.