PainAIPLANCT04361968
Combining Animal-assisted Intervention and Placebo-induced Analgesia
A study testing Dog only condition in people with Pain and Therapeutic Alliance, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Therapeutic Alliance, Placebo
- What is being tested?
- Dog only condition
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Jun 2020to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Right-handedness
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Division of Clinical Psychology and Psychotherapy, University of Basel
Basel, 4055
About this study
Official title: Combining Animal-assisted Intervention and Placebo-induced Analgesia: The Dog as Treatment in a Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
A growing body of literature suggests that animal-assisted interventions (AAI) have important clinical effects on humans, e.g. decreased physiological stress, reduction of depression and anxiety symptoms and reduction in pain perception and experience. Such evidence leads to an increased interest in using AAI in clinical practice. However, it is still not quite clear how AAI works or in other words what it is that makes AAI effective. Therefore, it is crucial to investigate how the inclusion of animals in clinical practice contributes to beneficial therapeutic outcomes.
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
- Pain, Therapeutic Alliance, Placebo
- Being tested
- Animal-assisted placebo condition, Placebo condition, Dog only condition, Control Condition
- Keywords
- Treatment Rationale, animal-assisted intervention
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Animal-assisted placebo condition |
| Placebo condition | Experimental | Participants receive verbal information that they are receiving an analgesic cream. Receives: Other: Placebo condition |
| Dog only condition | Experimental | Before meeting the dog, participants will get a therapeutic rationale for the presence of the dog. Receives: Other: Dog only condition |
| Control condition | Other | Participants in this condition will receive no intervention. Receives: Other: Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 5 minutes
Secondary outcomes (6)
Posttreatment objective heat threshold
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.
Measured: 10 minutes
Corresponding subjective ratings of pain intensity and unpleasantness of pain threshold.
Subjective ratings of pain intensity and unpleasantness will be measured with a visual analogue scale. ): 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).
Measured: 5 minutes
Pain expectancy and relief
The Expectancy of Relief Scale assesses how intensive and unpleasantness participants expect the pain to be after the treatment phase. The expectancy ratings are made on the same VAS (ranging from 1 to 10, (1= not intense/unpleasant at all; 10= the most intense/unpleasant pain) as those for pain intensity and pain unpleasantness.
Measured: 2 minutes
Participants perception of the study conductor assessed by questionnaire
Participants perception of the study conductor will be assessed with the Counselor Rating Form (CRF) Short questionnaire. The CRF-S assesses participant's perception of the study conductor and if their perception changes in the presence of absence of a dog. The CRF-S is a brief 12-items questionnaire that has been developed to measure people's perception of a therapist on total three subscales: trustworthiness, expertness and attractiveness (Corrigan and Schmidt, 1983). The questionnaire contains item such as "honest", "likeable", "trustworthy", "friendly" on a 7-point Likert scale ranging from 1 (not very) to 7 (very). This questionnaire will be used after baseline heat pain measurements and a second time after posttreatment heat pain measurements.
Measured: 10 minutes
Attitude towards dogs assessed by questionnaire
Attitude towards dogs will be assessed with the questionnaire on the attitude towards dogs (AAPL). This questionnaire was designed for this study. This questionnaire assesses if participants like dogs and animals. This study developed this questionnaire for this study.
Measured: 2 minutes
Kontextmodellfragebogen (KMF)/context model questionnaire
The KMF assesses the perception of participants of the study conductor and the credibility and expectation of the intervention. Participants fill out this questionnaire after the treatment phase.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start15 Jun 2020
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled parallel group within-subjects design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. phil. Karin Hediger, Faculty of Psychology, University of Basel, Switzerland
- Responsible party
- Sponsor
- Investigators
- Karin Hediger, Dr. phil, Study chair, Clinical Psychology and Psychotherapy, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361968
- Sponsor's protocol ID
- 2020- 00642
- Acronym
- AIPLA
- Status last verified
- Dec 2020
- First submitted
- 22 Apr 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators are planning on sharing the anonymized data on an openly assess platform.
Publications
Kelley JM, Kraft-Todd G, Schapira L, Kossowsky J, Riess H. The influence of the patient-clinician relationship on healthcare outcomes: a systematic review and meta-analysis of randomized controlled trials. PLoS One. 2014 Apr 9;9(4):e94207. doi: 10.1371/journal.pone.0094207. eCollection 2014.
PubMed 24718585Birkhauer J, Gaab J, Kossowsky J, Hasler S, Krummenacher P, Werner C, Gerger H. Trust in the health care professional and health outcome: A meta-analysis. PLoS One. 2017 Feb 7;12(2):e0170988. doi: 10.1371/journal.pone.0170988. eCollection 2017.
PubMed 28170443Antonioli C, Reveley MA. Randomised controlled trial of animal facilitated therapy with dolphins in the treatment of depression. BMJ. 2005 Nov 26;331(7527):1231. doi: 10.1136/bmj.331.7527.1231.
PubMed 16308382Calcaterra V, Veggiotti P, Palestrini C, De Giorgis V, Raschetti R, Tumminelli M, Mencherini S, Papotti F, Klersy C, Albertini R, Ostuni S, Pelizzo G. Post-operative benefits of animal-assisted therapy in pediatric surgery: a randomised study. PLoS One. 2015 Jun 3;10(6):e0125813. doi: 10.1371/journal.pone.0125813. eCollection 2015.
PubMed 26039494Colloca L, Sigaudo M, Benedetti F. The role of learning in nocebo and placebo effects. Pain. 2008 May;136(1-2):211-8. doi: 10.1016/j.pain.2008.02.006. Epub 2008 Mar 26.
PubMed 18372113Creary, P. (2017). The influence of the presence of a dog or cat on perceptions of a psychotherapist.
Fluckiger C, Del Re AC, Wampold BE, Symonds D, Horvath AO. How central is the alliance in psychotherapy? A multilevel longitudinal meta-analysis. J Couns Psychol. 2012 Jan;59(1):10-7. doi: 10.1037/a0025749. Epub 2011 Oct 10.
PubMed 21988681Waite TC, Hamilton L, O'Brien W. A meta-analysis of Animal Assisted Interventions targeting pain, anxiety and distress in medical settings. Complement Ther Clin Pract. 2018 Nov;33:49-55. doi: 10.1016/j.ctcp.2018.07.006. Epub 2018 Jul 20.
PubMed 30396626Vase L, Riley JL 3rd, Price DD. A comparison of placebo effects in clinical analgesic trials versus studies of placebo analgesia. Pain. 2002 Oct;99(3):443-452. doi: 10.1016/S0304-3959(02)00205-1.
PubMed 12406519Del Re AC, Fluckiger C, Horvath AO, Symonds D, Wampold BE. Therapist effects in the therapeutic alliance-outcome relationship: a restricted-maximum likelihood meta-analysis. Clin Psychol Rev. 2012 Nov;32(7):642-9. doi: 10.1016/j.cpr.2012.07.002. Epub 2012 Jul 21.
PubMed 22922705Ein N, Li L, Vickers K. The effect of pet therapy on the physiological and subjective stress response: A meta-analysis. Stress Health. 2018 Oct;34(4):477-489. doi: 10.1002/smi.2812. Epub 2018 Jun 8.
PubMed 29882342Fiori G, Marzi T, Bartoli F, Bruni C, Ciceroni C, Palomba M, Zolferino M, Corsi E, Galimberti M, Moggi Pignone A, Viggiano MP, Guiducci S, Calamai M, Matucci-Cerinic M. The challenge of pet therapy in systemic sclerosis: evidence for an impact on pain, anxiety, neuroticism and social interaction. Clin Exp Rheumatol. 2018 Jul-Aug;36 Suppl 113(4):135-141. Epub 2018 Sep 20.
PubMed 30277859Gaab J, Kossowsky J, Ehlert U, Locher C. Effects and Components of Placebos with a Psychological Treatment Rationale - Three Randomized-Controlled Studies. Sci Rep. 2019 Feb 5;9(1):1421. doi: 10.1038/s41598-018-37945-1.
PubMed 30723231Hsieh 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.
PubMed 25211164Kirsch I, Weixel LJ. Double-blind versus deceptive administration of a placebo. Behav Neurosci. 1988 Apr;102(2):319-23. doi: 10.1037//0735-7044.102.2.319.
PubMed 3365327
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Animal-assisted Intervention and Placebo-induced Analgesia: The Dog as Treatment in a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04361968
- Acronym / sponsor ID
- AIPLA / 2020- 00642
- Conditions
- Pain, Therapeutic Alliance, Placebo
- Keywords
- Treatment Rationale, animal-assisted intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Dr. phil. Karin Hediger, Faculty of Psychology, University of Basel, Switzerland
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A growing body of literature suggests that animal-assisted interventions (AAI) have important clinical effects on humans, e.g. decreased physiological stress, reduction of depression and anxiety symptoms and reduction in pain perception and experience. Such evidence leads to an increased interest in using AAI in clinical practice. However, it is still not quite clear how AAI works or in other words what it is that makes AAI effective. Therefore, it is crucial to investigate how the inclusion of animals in clinical practice contributes to beneficial therapeutic outcomes.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- randomized controlled parallel group within-subjects design
| Arm | Type | Receives |
|---|---|---|
| Animal-assisted placebo condition | Experimental | Other: Animal-assisted placebo conditionParticipants 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. |
| Placebo condition | Experimental | Other: Placebo conditionParticipants receive verbal information that they are receiving an analgesic cream. |
| Dog only condition | Experimental | Other: Dog only conditionBefore meeting the dog, participants will get a therapeutic rationale for the presence of the dog. |
| Control condition | Other | Other: Control ConditionParticipants in this condition will receive no intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Right-handedness
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animal-assisted placebo conditionParticipants receive the same verbal information as in the Placebo condition. Additionally, participants will receive the same verbal information as in the Dog only condition. | Other | Animal-assisted placebo condition |
| Placebo conditionParticipants 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. | Other | Placebo condition |
| Dog only conditionParticipants 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. | Other | Dog only condition |
| Control ConditionParticipants 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. | Other | Control condition |
Primary outcome
Posttreatment objective heat pain tolerance
Time frame: 10 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.
Corresponding subjective ratings of pain intensity and unpleasantness of pain tolerance
Time frame: 5 minutes
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).
6 secondary outcomes
Posttreatment objective heat threshold
Time frame: 10 minutes
Corresponding subjective ratings of pain intensity and unpleasantness of pain threshold.
Time frame: 5 minutes
Pain expectancy and relief
Time frame: 2 minutes
Participants perception of the study conductor assessed by questionnaire
Time frame: 10 minutes
Attitude towards dogs assessed by questionnaire
Time frame: 2 minutes
Kontextmodellfragebogen (KMF)/context model questionnaire
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Background: PubMed 24718585Kelley JM, Kraft-Todd G, Schapira L, Kossowsky J, Riess H. The influence of the patient-clinician relationship on healthcare outcomes: a systematic review and meta-analysis of randomized controlled trials. PLoS One. 2014 Apr 9;9(4):e94207. doi: 10.1371/journal.pone.0094207. eCollection 2014.
- Background: PubMed 28170443Birkhauer J, Gaab J, Kossowsky J, Hasler S, Krummenacher P, Werner C, Gerger H. Trust in the health care professional and health outcome: A meta-analysis. PLoS One. 2017 Feb 7;12(2):e0170988. doi: 10.1371/journal.pone.0170988. eCollection 2017.
- Background: PubMed 16308382Antonioli C, Reveley MA. Randomised controlled trial of animal facilitated therapy with dolphins in the treatment of depression. BMJ. 2005 Nov 26;331(7527):1231. doi: 10.1136/bmj.331.7527.1231.
- Background: PubMed 26039494Calcaterra V, Veggiotti P, Palestrini C, De Giorgis V, Raschetti R, Tumminelli M, Mencherini S, Papotti F, Klersy C, Albertini R, Ostuni S, Pelizzo G. Post-operative benefits of animal-assisted therapy in pediatric surgery: a randomised study. PLoS One. 2015 Jun 3;10(6):e0125813. doi: 10.1371/journal.pone.0125813. eCollection 2015.
- Background: PubMed 18372113Colloca L, Sigaudo M, Benedetti F. The role of learning in nocebo and placebo effects. Pain. 2008 May;136(1-2):211-8. doi: 10.1016/j.pain.2008.02.006. Epub 2008 Mar 26.
- BackgroundCreary, P. (2017). The influence of the presence of a dog or cat on perceptions of a psychotherapist.
- Background: PubMed 21988681Fluckiger C, Del Re AC, Wampold BE, Symonds D, Horvath AO. How central is the alliance in psychotherapy? A multilevel longitudinal meta-analysis. J Couns Psychol. 2012 Jan;59(1):10-7. doi: 10.1037/a0025749. Epub 2011 Oct 10.
- Background: PubMed 30396626Waite TC, Hamilton L, O'Brien W. A meta-analysis of Animal Assisted Interventions targeting pain, anxiety and distress in medical settings. Complement Ther Clin Pract. 2018 Nov;33:49-55. doi: 10.1016/j.ctcp.2018.07.006. Epub 2018 Jul 20.
- Background: PubMed 12406519Vase L, Riley JL 3rd, Price DD. A comparison of placebo effects in clinical analgesic trials versus studies of placebo analgesia. Pain. 2002 Oct;99(3):443-452. doi: 10.1016/S0304-3959(02)00205-1.
- Background: PubMed 22922705Del Re AC, Fluckiger C, Horvath AO, Symonds D, Wampold BE. Therapist effects in the therapeutic alliance-outcome relationship: a restricted-maximum likelihood meta-analysis. Clin Psychol Rev. 2012 Nov;32(7):642-9. doi: 10.1016/j.cpr.2012.07.002. Epub 2012 Jul 21.
- Background: PubMed 29882342Ein N, Li L, Vickers K. The effect of pet therapy on the physiological and subjective stress response: A meta-analysis. Stress Health. 2018 Oct;34(4):477-489. doi: 10.1002/smi.2812. Epub 2018 Jun 8.
- Background: PubMed 30277859Fiori G, Marzi T, Bartoli F, Bruni C, Ciceroni C, Palomba M, Zolferino M, Corsi E, Galimberti M, Moggi Pignone A, Viggiano MP, Guiducci S, Calamai M, Matucci-Cerinic M. The challenge of pet therapy in systemic sclerosis: evidence for an impact on pain, anxiety, neuroticism and social interaction. Clin Exp Rheumatol. 2018 Jul-Aug;36 Suppl 113(4):135-141. Epub 2018 Sep 20.
- Individual participant dataSharing planned: No. The investigators are planning on sharing the anonymized data on an openly assess platform.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin Hediger, Dr. phil study chair
Clinical Psychology and Psychotherapy, University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dog only condition in people with Pain and Therapeutic Alliance, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posttreatment objective heat pain tolerance (time frame: 10 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04361968, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.