CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 128 enrolled
Drug / intervention
Animal-assisted placebo condition +3 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04361968
NCT04361968N/ACompleted

Combining Animal-assisted Intervention and Placebo-induced Analgesia: The Dog as Treatment in a Randomized Controlled Trial

University Hospital, Basel, Switzerland·interventional·Posted Apr 24, 2020·Updated Dec 17, 2020

In Brief

A clinical study evaluating Animal-assisted placebo condition, Placebo condition, and 2 other interventions for Pain and 2 related conditions. Completed, enrolled 128 participants across 1 site.

Detailed 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 mere presence of an animal influences the therapeutic alliance between therapist and client. 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSwitzerland

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedApr 24, 2020
Enrollment StartJun 15, 2020
Primary CompletionNov 30, 2020
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 6.2 years ago

Interventions

Animal-assisted placebo conditionother

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 conditionother

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 conditionother

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 Conditionother

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.