Pain Processing In Relation To Breathing

NCT06169917 | Unknown

• 1 other identifier: 2023-00518
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate the effect of breathing on the processing of experimental pain in healthy participants. The main questions are:

• will receive heat stimuli
• 's skin's sensitivity will be tested using quantitative sensory testing tools.
• will receive various instructions on the speed of their breathing
• 's heart rate, respiratory rate and sweat response will be measured
• will fill in questionnaires Researchers will compare the spatial extent of sensitivity resulting from application of heat stimuli during paced resonance frequency breathing compared to paced breathing at a natural frequency to see if the breathing rhythm influences central sensitization processes.

Conditions

Central Sensitisation; Pain

Outcome Measures

Primary Outcomes (1)

• Area of Hypersensitivity surrounding the primary stimulation site

  Before and after thermal stimulations, the sensitivity of the skin is tested using a von Frey Filament, a Pin Prick and a brush. Thermal stimulations cause hypersensitivity of the skin, resulting in an area of hypersensitivity surrounding the stimulation site. The primary outcome measure is the amount of change in the area of hypersensitivity from before to after the thermal stimulations. The measuring unit of this outcome is square centimetres.

  40 minutes

Secondary Outcomes (4)

• Power in the Low-frequency Range of the Heart Rate Variability

  25 minutes

• Root Mean Square of Successive Differences of the Heart Rate Variability

  25 minutes

• Galvanic Skin Potential

  25 minutes

• Threshold and Magnitude of the Nociceptive Withdrawal Reflex

  25 minutes

Study Arms (1)

Healthy participants

EXPERIMENTAL

Participants should be aged 18-40, in good health, capable of informed consent, without major medical/psychiatric conditions (e.g., heart disease, diabetes, autoimmune disorders, infectious diseases, major depressive disorder), chronic pain, respiratory issues, or ongoing acute pain, qualify. Exclusions: inability to follow instructions (e.g., language issues), recent alcohol/drug/analgesic use (\<24h), caffeine intake (\>100mg \<8h), or scar tissue/general reduced sensitivity in test areas. Participants undergo three interventions. The heat stimulation intervention is performed twice. During one heat stimulation intervention, participants receive the 'resonance frequency breathing' intervention. During the other heat stimulation intervention, participants receive the 'natural frequency breathing' intervention. The order of the breathing interventions is counterbalanced across participants.

Behavioral: Paced Resonance Frequency Breathing; Behavioral: Paced Breathing at Natural Frequency; Other: Heat Stimulations

Interventions

Paced Resonance Frequency Breathing BEHAVIORAL

Participants are required to pace their breathing to their pre-determined individual resonance frequency.

Healthy participants

Paced Breathing at Natural Frequency BEHAVIORAL

Participants are required to pace their breathing to their pre-determined individual breathing frequency at rest.

Healthy participants

Heat Stimulations OTHER

Participants will undergo a heat stimulation procedure on their left and right foot (the order of which is counterbalanced across participants). During this procedure, there are 10 blocks, with an inter-stimulus interval of 30 seconds between two blocks. During a block, six 6-second heat stimulations (48 degrees) are given. Between the stimulations, the temperature quickly returns to baseline (32 degrees).

Healthy participants

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• over 18 and below 40 years of age
• good general health
• able to give informed consent

You may not qualify if:

• any major medical or psychiatric condition (e.g. heart disease, diabetes, autoimmune disorders, infectious diseases, major depressive disorder), any chronic pain condition, any respiratory problems, any current acute pain at time of study
• inability to follow study instructions, e.g. due to language problems
• Consumption of alcohol, drugs, analgesics within the last 24 h
• Consumption of no more than 100 mg of caffeine within the last 8 h
• Scar tissue or generally reduced sensitivity in the designated testing site areas
• Shoe size \< 38
• Restless-Legs-Syndrome

Sponsors & Collaborators

• Balgrist University Hospital: lead

Study Sites (1)

University Hospital Balgrist, University Zürich

Zurich, 8008, Switzerland

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Petra Schweinhardt, Prof. Dr. med

CONTACT

+41 44 510 73 81; petra.schweinhardt@balgrist.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: December 14, 2023
• Study Start: May 14, 2023
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: December 14, 2023

Record last verified: 2023-12

Locations

CH (1)