The Role of Sound in Enhancing or Disabling the Placebo Effect of a Deactivated Transcutaneous Electrical Nerve Stimulator (TENS) Device on Hypoalgesia in Healthy Volunteers

NCT ID: NCT06981260

Last Updated: 2025-05-20

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-13

Study Completion Date

2016-06-14

Brief Summary

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Placebo responses are now recognized for their clinical and physiological significance. Non-pharmacological cues such as sound may enhance or induce these responses. This trial aims to assess the effect of sound on the placebo-induced hypoalgesia elicited by a deactivated TENS device in healthy individuals.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A healthy volunteer pilot study.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participant and assessor blinded

Study Groups

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Group A: Placebo with sound

Deactivated transcutaneous electrical nerve stimulation (TENS) with beeping sound (15-second interval)

Group Type EXPERIMENTAL

Group A Deactivated TENS with beeping sound (15-second interval)

Intervention Type PROCEDURE

Deactivated TENS with beeping sound (15-second interval)

Group B: Placebo with no sound

Group B: Deactivated transcutaneous electrical nerve stimulation (TENS) without sound

Group Type EXPERIMENTAL

Group B

Intervention Type PROCEDURE

Deactivated TENS without sound

Interventions

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Group A Deactivated TENS with beeping sound (15-second interval)

Deactivated TENS with beeping sound (15-second interval)

Intervention Type PROCEDURE

Group B

Deactivated TENS without sound

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* No history of TENS use

Exclusion Criteria

* Current medication use
* Orthopedic, neurological, or systemic conditions
* Pregnancy (current and planned)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aegean College, Athens, Greece

UNKNOWN

Sponsor Role collaborator

Coventry University, United Kingdom

UNKNOWN

Sponsor Role collaborator

Institute of Health and Resilience

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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SOUNDPLACEBO-2016-001

Identifier Type: -

Identifier Source: org_study_id

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