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Animal-assisted Placebo-induced Analgesia (AAPL)

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ClinicalTrials.gov Identifier: NCT03898141
Recruitment Status : Completed
First Posted : April 1, 2019
Last Update Posted : July 31, 2019
Sponsor:
Collaborator:
Prof. Undine Lang, University Psychiatric Clinics (UPK), Basel, Switzerland
Information provided by (Responsible Party):
Dr. Karin Hediger, University of Basel

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.


Condition or disease Intervention/treatment Phase
Pain Relations, Researcher-Subject Other: Placebo (PL) Other: Dog only (DO) Other: Animal-assisted placebo (AAPL) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled parallel group within-subjects design
Masking: Single (Participant)
Masking Description:

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.

Primary Purpose: Basic Science
Official Title: Animal-assisted Placebo-induced Analgesia: A Randomized Controlled Trial in Healthy Participants
Actual Study Start Date : March 27, 2019
Actual Primary Completion Date : July 2, 2019
Actual Study Completion Date : July 2, 2019

Arm Intervention/treatment
Experimental: Animal-assisted placebo condition (AAPL)

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

Placebo Comparator: Placebo only (PO)
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)
Participants will get deceptive and receive an inert cream (=placebo intervention) that "reduces pain".

Experimental: Dog only (DO)

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)
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).

No Intervention: No dog, no placebo (ND)
Participants will participant will have the verbal information that the applied cream only moisturizes the skin to allow accurate pain measurements.



Primary Outcome Measures :
  1. Heat pain tolerance assessed by TSA-II [ Time Frame: 30 minutes ]
    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.


Secondary Outcome Measures :
  1. Participants perception of the experimenter I [ Time Frame: 15 minutes ]

    Participants perception of the experimenter will be conducted via the KMS (Adapted version of the Context Model Questionnaire CMQ) questionnaire twice, after each pain induction phase (baseline and posttreatment).

    KMF has 16 items with a scale from 1-5 (1= not at all, 5= very much, with a higher score indicating a better outcome. All items will be analyzed individual.


  2. Participants perception of the experimenter II [ Time Frame: 15 minutes ]

    Participants perception of the experimenter will also be conducted via the CRF-S questionnaire (Counselor Rating Form Short) twice, after each pain induction phase (baseline and posttreatment).

    CRF-S questions contains 12 items on a scale from 1-7 (1= not much, 7= very much, with a higher score indicating a better outcome. All items will be analyzed individual.


  3. Heat pain threshold assessed by TSA-II [ Time Frame: 30 minutes ]
    Heat pain threshold will be determined by the methods of limits. Temperature will be increased from the baseline (32°C) at a rate of 0.5°C /s. Participants are instructed to press the button to determine the turning point from perceiving warmth to the perception of pain. When the pain threshold has been reached, the device will resume from its baseline (32 °C) with a rise of 0.5 °C/s. This procedure will be repeated three times. Pain threshold will be defined as the average of the three measurements.


Other Outcome Measures:
  1. Pain expectancy by the VAS scale (visual analogue scale) [ Time Frame: 5 minutes ]

    This should detect if participants expectancy changes after the intervention phase and if eventually the presence of a dog has an impact on expectancy.

    VAS scale ranges from 0-10 (0 = no pain at all; 10= the worst imaginable pain)




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Right-handedness

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898141


Locations
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Switzerland
Division Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel
Basel, Base-Stadt, Switzerland, 4055
Sponsors and Collaborators
University of Basel
Prof. Undine Lang, University Psychiatric Clinics (UPK), Basel, Switzerland

Publications:

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Responsible Party: Dr. Karin Hediger, Principal Investigator, University of Basel
ClinicalTrials.gov Identifier: NCT03898141     History of Changes
Other Study ID Numbers: 006-19-1
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We are planning on sharing the anonymized data on a openly assess platform.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No