Combining Animal-assisted Intervention and Placebo-induced Analgesia

NCT04361968 | Completed DMC

• 1 other identifier: 2020- 00642
• Study Type: interventional
• Target: 128
• 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 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.

Conditions

Pain; Therapeutic Alliance; Placebo

Keywords

Treatment Rationale; animal-assisted intervention

Outcome Measures

Primary Outcomes (2)

• Posttreatment objective heat pain tolerance

  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.

  10 minutes

• Corresponding subjective ratings of pain intensity and unpleasantness of pain tolerance

  Subjective ratings of pain intensity and unpleasantness will be measured with a visual analogue scale (VAS): Following each pain stimuli with the TSA-II participants have to respond on a VAS how intense and unpleasant the pain is. The range of the scale is from 1-10 (1= not intense/unpleasant at all; 10= the most intense/unpleasant pain).

  5 minutes

Secondary Outcomes (6)

• Posttreatment objective heat threshold

  10 minutes

• Corresponding subjective ratings of pain intensity and unpleasantness of pain threshold.

  5 minutes

• Pain expectancy and relief

  2 minutes

• Participants perception of the study conductor assessed by questionnaire

  10 minutes

• Attitude towards dogs assessed by questionnaire

  2 minutes

Study Arms (4)

Animal-assisted placebo condition

EXPERIMENTAL

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.

Other: Animal-assisted placebo condition

Placebo condition

EXPERIMENTAL

Participants receive verbal information that they are receiving an analgesic cream.

Other: Placebo condition

Dog only condition

EXPERIMENTAL

Before meeting the dog, participants will get a therapeutic rationale for the presence of the dog.

Other: Dog only condition

Control condition

OTHER

Participants in this condition will receive no intervention.

Other: Control Condition

Interventions

Animal-assisted placebo condition OTHER

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.

Animal-assisted placebo condition

Placebo condition OTHER

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.

Placebo condition

Dog only condition OTHER

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.

Dog only condition

Control Condition OTHER

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.

Control condition

Eligibility Criteria

• Age: 18 Years - 65 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 by self-report
• 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.)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Dr. phil. Karin Hediger, Faculty of Psychology, University of Basel, Switzerland: collaborator

Study Sites (1)

Division of Clinical Psychology and Psychotherapy, University of Basel

Basel, 4055, Switzerland

Location

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MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Karin Hediger, Dr. phil

  Clinical Psychology and Psychotherapy, University of Basel

  STUDY CHAIR

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: SPONSOR

Model Details: randomized controlled parallel group within-subjects design

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 24, 2020
• Study Start: June 15, 2020
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)