Combining Animal-assisted Intervention and Placebo-induced Analgesia
NCT ID: NCT04361968
Last Updated: 2020-12-17
Study Results
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Basic Information
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COMPLETED
NA
128 participants
INTERVENTIONAL
2020-06-15
2020-11-30
Brief Summary
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However, results from a recent study suggest that a relationship between patient and health-provider alone is not sufficient to influence treatment outcomes, but that a therapeutic rationale is needed and that verbal instructions and suggestions are highly important in shaping participants' treatment expectations.
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) placebo intervention , no dog present, b) placebo intervention, dog present, c) no placebo intervention, no dog present and d) no placebo intervention, dog present.
The dog will be introduced after randomization. Expectancy will be induced by telling participants that the contact to an animal increases the oxytocin level, which has an non inflammatory effect.
The placebo intervention will be 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.
Detailed Description
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In this regard, it has been assumed that the presence of an animal enhances the development of the therapeutic alliance, which, in turn, has been shown to play a crucial role in the outcome of the treatment.
However, results from a recent study suggest that a relationship between patient and health-provider alone is not sufficient to influence treatment outcomes, but that a therapeutic rationale is needed and that verbal instructions and suggestions are highly important in shaping participants' treatment expectations.
As placebo effects are related to therapeutic rationale and relationship, the investigators would like to use an expectancy-induced placebo intervention to identify if animal-assisted intervention also works through these two components.
Given that placebo analgesia works well through therapeutic rationale the investigators decided to employ an animal-integrated placebo intervention study with healthy participants (N=128) in a standardized experimental heat pain paradigm. Even though a growing body of evidence highlights the positive effects of animal-assisted interventions until this day little is known about the mechanisms. There exist various hypotheses trying to explain why AAI works, most focusing on the crucial role of the animal in the intervention. However, to the best of the investigator's knowledge there has been no study which examined if the effectiveness of animal-assisted interventions could simply be explained by the power of the therapeutic rational and the relationship. Therefore, it is still unknown if AAI is effective because of the animal or because of its influence on the therapeutic relationship and the given therapeutic rationale.
It is important to understand how AAI works. Moreover, if AAI, like other interventions, is about expectation and relationship, this could have important implications for clinical practice and a better understanding of how AAI must be used to be effective.
If AAI works through similar mechanisms as the placebo, then both interventions should have a similar impact on the outcome of the intervention (reduced pain perception, increased placebo analgesia). Findings of this study could have important implications, not only for clinical practice of AAI but also for intervention in general as the results could help to better understand the importance of these two components.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
After the termination of the study, all the subjects are debriefed regarding the real experimental procedures.
Study Groups
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Animal-assisted placebo condition
Participants receive verbal information that they are receiving an analgesic cream. Additionally, and before getting the dog, participants will get a therapeutic rationale for the presence of the dog.
Animal-assisted placebo condition
Participants receive the same verbal information as in the Placebo condition. Additionally, participants will receive the same verbal information as in the Dog only condition.
Placebo condition
Participants receive verbal information that they are receiving an analgesic cream.
Placebo condition
Participants receive verbal information that they are receiving an analgesic cream (i.e. ""Antidolor, containing Lidocain"), which has been shown to produce significant pain reduction in previous clinical trials. However, they will receive an inert cream.
Dog only condition
Before meeting the dog, participants will get a therapeutic rationale for the presence of the dog.
Dog only condition
Participants will get a therapeutic rationale for the presence of the dog. The rationale is supported in the literature and therefore not invented for the purpose of this study. Participants will be told that: "Studies have shown the presence of an animal can affect pain perception because the presence and the interaction with an animal can increase our Oxytocin level. Therefore, the investigators want to examine if the presence of a dog has an impact on your pain perception. While participants have to wait for the action time of the cream they are allowed to pet 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. The dog will always be lying at the same spot. Participants will still be able to see the dog.
Control condition
Participants in this condition will receive no intervention.
Control Condition
Participants in this condition will receive no intervention. All instructions will be conveyed in a standardized manner to ensure that the participant-experimenter relationship is comparable in terms of friendliness and attention across all four conditions.
Interventions
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Animal-assisted placebo condition
Participants receive the same verbal information as in the Placebo condition. Additionally, participants will receive the same verbal information as in the Dog only condition.
Placebo condition
Participants receive verbal information that they are receiving an analgesic cream (i.e. ""Antidolor, containing Lidocain"), which has been shown to produce significant pain reduction in previous clinical trials. However, they will receive an inert cream.
Dog only condition
Participants will get a therapeutic rationale for the presence of the dog. The rationale is supported in the literature and therefore not invented for the purpose of this study. Participants will be told that: "Studies have shown the presence of an animal can affect pain perception because the presence and the interaction with an animal can increase our Oxytocin level. Therefore, the investigators want to examine if the presence of a dog has an impact on your pain perception. While participants have to wait for the action time of the cream they are allowed to pet 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. The dog will always be lying at the same spot. Participants will still be able to see the dog.
Control Condition
Participants in this condition will receive no intervention. All instructions will be conveyed in a standardized manner to ensure that the participant-experimenter relationship is comparable in terms of friendliness and attention across all four conditions.
Eligibility Criteria
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Inclusion Criteria
* Right-handedness
Exclusion Criteria
* 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
* Pregnancy
* 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.)
18 Years
65 Years
ALL
Yes
Sponsors
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Dr. phil. Karin Hediger, Faculty of Psychology, University of Basel, Switzerland
UNKNOWN
University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Karin Hediger, Dr. phil
Role: STUDY_CHAIR
Clinical Psychology and Psychotherapy, University of Basel
Locations
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Division of Clinical Psychology and Psychotherapy, University of Basel
Basel, , Switzerland
Countries
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References
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Other Identifiers
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2020- 00642
Identifier Type: -
Identifier Source: org_study_id