Clinical Trials Directory

Trials / Completed

CompletedNCT05206383

Influence of Oral Messages on the Activity of Wrist and Finger Flexor Muscles

Influence of Oral Messages on the Activity of Wrist and Finger Flexor Muscles - in the Context of Application of Sham Therapy

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
90 (actual)
Sponsor
John Paul II University in Biała Podlaska · Academic / Other
Sex
All
Age
19 Years – 24 Years
Healthy volunteers
Accepted

Summary

The aim of the study will be to evaluate the effect of oral messages on wrist and finger flexor muscle activity during the application of sham therapy in the form of paper plaster. For years, research has been conducted on the effects of dynamic plaster and rigid plaster on muscle function. In many cases, reports from different authors are contradictory. Therefore, the planned study will use placebo paper plaster with no proven therapeutic effect.

Detailed description

People's words can have a huge impact on how we interpret our surroundings, what we expect and experience, and how we behave. The placebo (and nocebo) effects are a clear example here. The way health professionals discuss, describe and inform patients about the characteristic effects of a given disease, its prevention, diagnosis and treatment influences patients' feelings and expectations, which in turn affects their psychobiological responses, subjective feelings and treatment outcomes. The right choice of words by clinicians influences patients' response to medical treatments and procedures, both active and sham. The way in which information about the effects of treatment is communicated to patients can reinforce the outcomes of a particular treatment (placebo) or reverse clinically-proven effects of an active treatment, or even increase its adverse effects. The right messages can reduce the nocebo effect. And vice versa, the wrong choice of information provided may increase the patient's anxiety and disease symptoms. The aim of the study will be to evaluate the effect of oral messages on wrist and finger flexor muscle activity during the application of sham therapy in the form of paper plaster. Main hypothesis: The use of a positive message will have an effect on increasing the activation and strength of the flexor muscles of the wrist joint and fingers. Research questions: 1. Does a positive message have an effect on increasing the activation and strength of the flexor muscles of the wrist joint and fingers? 2. Does a negative message have an effect on increasing the activation and strength of the flexor muscles of the wrist joint and fingers? Does a neutral message have an effect on increasing the activation and strength of the flexor muscles of the wrist joint and fingers? The study will be a prospective, flow-up study using a differential variable in the form of the type of message used (positive - placebo, negative - nocebo, neutral). The respondents will be randomly allocated to study groups using sealed allocation sheets. Before taking part in the study, each subject will be familiarised with the course of the study and must give written informed consent to participate in the study and to be randomly assigned to a specific study group. The subjects will be assessed twice - before applying a paper plaster and 10 minutes after applying the plaster and delivering a voice message.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPositive message - placeboSubjects who will be told that "the applied plastering method significantly increases muscle strength" (positive message - placebo).
BEHAVIORALNegative message - noceboSubjects who will be told that "the applied plastering method has no effect on muscle strength" (negative message - nocebo).
BEHAVIORALNeutral messageSubjects who will be told that "the applied plastering method is currently under investigation and the investigators do not know its effects" (neutral message).

Timeline

Start date
2021-12-01
Primary completion
2022-04-30
Completion
2022-08-08
First posted
2022-01-25
Last updated
2022-08-10

Locations

1 site across 1 country: Poland

Source: ClinicalTrials.gov record NCT05206383. Inclusion in this directory is not an endorsement.