Animal-assisted Placebo-induced Analgesia

NCT03898141 | Completed

• 1 other identifier: 006-19-1
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

An increased interest of animal-assisted interventions (AAI) can be observed within clinical practice, even though it is still not entirely clear how the presence of an animal contributes to the outcome of a treatment. One theory maintains that the presence of an animal influences the relationship between health-provider and patient, which then in turn affects the outcome of the treatment. To investigate this theory, this study will combine AAI with a placebo intervention, as placebo interventions offer the basic form of intervention working through relationship and expectancy. The effects of the presence of a dog will be assessed with a standardized experimental heat pain paradigm (TSA-II) in a randomized controlled trial in healthy participants (N=128). After a baseline measurements of heat pain threshold and tolerance, participants will be randomly assigned to one of the following four conditions: a) analgesia-expectation, no dog present, b) analgesia-expectation, dog present, c) no-expectation, no dog present and d) no-expectation, dog present. The dog will be introduced after randomization. Expectancy will be induced by a deceptive cream which is said to helps against pain. Afterwards, posttreatment measurements will be conducted and participants fill in questionnaires about their perceptions of the experimenter.

Conditions

Pain; Relations, Researcher-Subject

Outcome Measures

Primary Outcomes (1)

• Heat pain tolerance assessed by TSA-II

  Heat stimuli will be administered to the right volar forearm using a 30x 30-mm Peltier device (Medoc, Ramatishai, Israel; TSA-II) placed at 2/3 of the distance from wrist to elbow. Pain tolerance will be determined by the method of limits: Participants will be asked to stop the increasing heat stimulus at the moment they cannot stand the heat any longer. Three measurements will start at 32 °C, with a rise of 0.5 °C/s. Heat tolerance will be defined as the average of the three measurements.

  30 minutes

Secondary Outcomes (3)

• Participants perception of the experimenter I

  15 minutes

• Participants perception of the experimenter II

  15 minutes

• Heat pain threshold assessed by TSA-II

  30 minutes

Other Outcomes (1)

• Pain expectancy by the VAS scale (visual analogue scale)

  5 minutes

Study Arms (4)

Animal-assisted placebo condition (AAPL)

EXPERIMENTAL

Participants will receive verbal information that they are receiving an analgesic cream (i.e. ""Anti-dolor, containing Lidocain "), which has been shown to produce significant pain reduction in previous clinical trials. However, they will receive an inert cream. Additionally, they will be told that a dog will be present during the experiment to examine whether animals can be present during experimental studies or if they are too big of a distraction. Prior to the pain assessment, participants are allowed to greet the dog. The intensity of interaction will be documented and be rated on a scale from 1-5 (1=very low degree of interaction, 5=very high de-gree of interaction). During the experiment the dog will be lying in the room with some distance to participants to avoid further physical interaction. The dog will always be lying at the same spot. Therefore, the distance between participant and dog will always be the same. However, partici-pants will still be able to see the dog.

Other: Animal-assisted placebo (AAPL)

Placebo only (PO)

PLACEBO COMPARATOR

Participants will receive verbal information that they are receiving an analgesic cream (i.e. ""Anti-dolor, containing Lidocain "), which has been shown to produce significant pain reduction in previous clinical trials. However, they will receive an inert cream.

Other: Placebo (PL)

Dog only (DO)

EXPERIMENTAL

Participants will be told that a dog will be present during the experiment to examine whether animals can be present during experimental studies or if they are too big of a distraction. Prior to the pain assessment, participants are allowed to greet the dog. The intensity of interaction will be documented and be rated on a scale from 1-5 (1=very low degree of interaction, 5=very high degree of interaction). During the experiment the dog will be lying in the room with some distance to participants to avoid further physical interaction. During the experiment the dog will be lying in the room with some distance to avoid further physical interaction. After the introduction of the dog, participant will have the verbal information that the applied cream only moisturizes the skin to allow accurate pain measurements

Other: Dog only (DO)

No dog, no placebo (ND)

NO INTERVENTION

Participants will participant will have the verbal information that the applied cream only moisturizes the skin to allow accurate pain measurements.

Interventions

Placebo (PL) OTHER

Participants will get deceptive and receive an inert cream (=placebo intervention) that "reduces pain".

Placebo only (PO)

Dog only (DO) OTHER

In the dog intervention a dog will be present during the second measurements. However, participants will only learn the true aims of the presence of the dog after the study (delayed informed consent).

Dog only (DO)

Animal-assisted placebo (AAPL) OTHER

Participants receive the placebo intervention in the presence of a dog.

Animal-assisted placebo condition (AAPL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Right-handedness

You may not qualify if:

• Being scared of dogs or dog hair allergy by self-report
• Any acute or chronic disease (chronic pain, hypertension, heart disease, renal disease, liver disease, diabetes) as well as skin pathologies, neuropathies or nerve entrapment symptoms, sensory abnormalities affecting the tactile or thermal modality
• Current medications (psychoactive medication, narcotics, intake of analgesics) or being currently in psychological or psychiatric treatment
• Insufficient German language skills to understand the instructions
• Previous participation in studies using pain assessment with Peltier Devices
• Current or regular drug consumption (THC, cocaine, heroin, etc.)
• pregnancy
• nursing women

Sponsors & Collaborators

• University of Basel: lead
• Prof. Undine Lang, University Psychiatric Clinics (UPK), Basel, Switzerland: collaborator

Study Sites (1)

Division Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel

Basel, Base-Stadt, 4055, Switzerland

Location

Related Publications (8)

• Hsieh C, Kong J, Kirsch I, Edwards RR, Jensen KB, Kaptchuk TJ, Gollub RL. Well-loved music robustly relieves pain: a randomized, controlled trial. PLoS One. 2014 Sep 11;9(9):e107390. doi: 10.1371/journal.pone.0107390. eCollection 2014.

  PMID: 25211164 BACKGROUND

• Locher C, Frey Nascimento A, Kirsch I, Kossowsky J, Meyer A, Gaab J. Is the rationale more important than deception? A randomized controlled trial of open-label placebo analgesia. Pain. 2017 Dec;158(12):2320-2328. doi: 10.1097/j.pain.0000000000001012.

  PMID: 28708766 BACKGROUND

• Krummenacher P, Candia V, Folkers G, Schedlowski M, Schonbachler G. Prefrontal cortex modulates placebo analgesia. Pain. 2010 Mar;148(3):368-374. doi: 10.1016/j.pain.2009.09.033. Epub 2009 Oct 28.

  PMID: 19875233 BACKGROUND

• Krummenacher P, Kossowsky J, Schwarz C, Brugger P, Kelley JM, Meyer A, Gaab J. Expectancy-induced placebo analgesia in children and the role of magical thinking. J Pain. 2014 Dec;15(12):1282-93. doi: 10.1016/j.jpain.2014.09.005. Epub 2014 Sep 23.

  PMID: 25261340 BACKGROUND

• Hermann C, Hohmeister J, Demirakca S, Zohsel K, Flor H. Long-term alteration of pain sensitivity in school-aged children with early pain experiences. Pain. 2006 Dec 5;125(3):278-285. doi: 10.1016/j.pain.2006.08.026. Epub 2006 Oct 2.

  PMID: 17011707 BACKGROUND

• Petersen GL, Finnerup NB, Norskov KN, Grosen K, Pilegaard HK, Benedetti F, Price DD, Jensen TS, Vase L. Placebo manipulations reduce hyperalgesia in neuropathic pain. Pain. 2012 Jun;153(6):1292-1300. doi: 10.1016/j.pain.2012.03.011. Epub 2012 Apr 13.

  PMID: 22503337 BACKGROUND

• Price DD. Psychological and neural mechanisms of the affective dimension of pain. Science. 2000 Jun 9;288(5472):1769-72. doi: 10.1126/science.288.5472.1769.

  PMID: 10846154 BACKGROUND

• Oldfield RC. The assessment and analysis of handedness: the Edinburgh inventory. Neuropsychologia. 1971 Mar;9(1):97-113. doi: 10.1016/0028-3932(71)90067-4. No abstract available.

  PMID: 5146491 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: As the employed study design necessitates the deception of participants about the true nature of the used intervention, i.e. placebo cream and the true aim of the dog's presence. After the termination of the study, all the subjects are debriefed regarding the real experimental procedures.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized controlled parallel group within-subjects design

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: April 1, 2019
• Study Start: March 27, 2019
• Primary Completion: July 2, 2019
• Study Completion: July 2, 2019
• Last Updated: July 31, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)