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

Institute of Health and Resilience

Status and phase: Completed; Early Phase 1

Conditions: Healthy

Treatments: Procedure: Group A Deactivated TENS with beeping sound (15-second interval); Procedure: Group B

Study type: Interventional

Funder types: Other

Identifiers

NCT06981260

SOUNDPLACEBO-2016-001

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• No history of TENS use

Exclusion criteria

• Current medication use
• Orthopedic, neurological, or systemic conditions
• Pregnancy (current and planned)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups

Group A: Placebo with sound

Experimental group

Description:

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

Treatment:

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

Group B: Placebo with no sound

Experimental group

Description:

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

Treatment:

Procedure: Group B