Pain Clinical Trial
— AIPLAOfficial title:
Combining Animal-assisted Intervention and Placebo-induced Analgesia: The Dog as Treatment in a Randomized Controlled Trial
Verified date | December 2020 |
Source | University Hospital, Basel, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 128 |
Est. completion date | November 30, 2020 |
Est. primary completion date | November 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Age = 18 years - Right-handedness Exclusion Criteria: - 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.) |
Country | Name | City | State |
---|---|---|---|
Switzerland | Division of Clinical Psychology and Psychotherapy, University of Basel | Basel |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Basel, Switzerland | Dr. phil. Karin Hediger, Faculty of Psychology, University of Basel, Switzerland |
Switzerland,
Antonioli C, Reveley MA. Randomised controlled trial of animal facilitated therapy with dolphins in the treatment of depression. BMJ. 2005 Nov 26;331(7527):1231. — View Citation
Birkhäuer 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. — View Citation
Calcaterra 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. — View Citation
Colloca 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. — View Citation
Corrigan, J. D., & Schmidt, L. D. (1983). Development and validation of revisions in the Counselor Rating Form. Journal of Counseling Psychology, 30(1), 64.
Creary, P. (2017). The influence of the presence of a dog or cat on perceptions of a psychotherapist.
Del Re AC, Flückiger 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. — View Citation
Ein 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. Review. — View Citation
Fiori 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. — View Citation
Flückiger 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. — View Citation
Gaab 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. — View Citation
Hoffmann, A. O., et al. (2009).
Horvath AO, Del Re AC, Flückiger C, Symonds D. Alliance in individual psychotherapy. Psychotherapy (Chic). 2011 Mar;48(1):9-16. doi: 10.1037/a0022186. — View Citation
Hsieh 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. — View Citation
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. Review. Erratum in: PLoS One. 2014;9(6):e101191. — View Citation
Kirsch I, Weixel LJ. Double-blind versus deceptive administration of a placebo. Behav Neurosci. 1988 Apr;102(2):319-23. — View Citation
Kruger, K. A. and J. A. Serpell (2010). Animal-assisted interventions in mental health: Definitions and theoretical foundations. Handbook on animal-assisted therapy, Elsevier: 33-48.
Krummenacher P, Candia V, Folkers G, Schedlowski M, Schönbächler G. Prefrontal cortex modulates placebo analgesia. Pain. 2010 Mar;148(3):368-74. doi: 10.1016/j.pain.2009.09.033. Epub 2009 Oct 28. — View Citation
Krummenacher P, Kossowsky J, Schwarz C, Brugger P, Kelley JM, Meyer A, Gaab J. Expectancy-induced placebo analgesia in children and the role of magical thinking. J Pain. 2014 Dec;15(12):1282-93. doi: 10.1016/j.jpain.2014.09.005. Epub 2014 Sep 23. — View Citation
Le Roux, M. C. and R. Kemp (2009).
Locher C, Frey Nascimento A, Kirsch I, Kossowsky J, Meyer A, Gaab J. Is the rationale more important than deception? A randomized controlled trial of open-label placebo analgesia. Pain. 2017 Dec;158(12):2320-2328. doi: 10.1097/j.pain.0000000000001012. — View Citation
Odendaal JS, Meintjes RA. Neurophysiological correlates of affiliative behaviour between humans and dogs. Vet J. 2003 May;165(3):296-301. — View Citation
Odendaal JS. Animal-assisted therapy - magic or medicine? J Psychosom Res. 2000 Oct;49(4):275-80. Review. — View Citation
Oldfield RC. The assessment and analysis of handedness: the Edinburgh inventory. Neuropsychologia. 1971 Mar;9(1):97-113. — View Citation
Petersson M, Alster P, Lundeberg T, Uvnäs-Moberg K. Oxytocin increases nociceptive thresholds in a long-term perspective in female and male rats. Neurosci Lett. 1996 Jul 12;212(2):87-90. — View Citation
Petersson M, Eklund M, Uvnäs-Moberg K. Oxytocin decreases corticosterone and nociception and increases motor activity in OVX rats. Maturitas. 2005 Aug 16;51(4):426-33. Epub 2004 Dec 25. — View Citation
Petrovic P, Dietrich T, Fransson P, Andersson J, Carlsson K, Ingvar M. Placebo in emotional processing--induced expectations of anxiety relief activate a generalized modulatory network. Neuron. 2005 Jun 16;46(6):957-69. — View Citation
Pollo A, Amanzio M, Arslanian A, Casadio C, Maggi G, Benedetti F. Response expectancies in placebo analgesia and their clinical relevance. Pain. 2001 Jul;93(1):77-84. — View Citation
Souter, M. A. and M. D. Miller (2007).
Vase 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):443-52. — View Citation
Waite 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. — View Citation
* Note: There are 31 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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. | 10 minutes | |
Secondary | 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). | 5 minutes | |
Secondary | 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. | 2 minutes | |
Secondary | 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. | 10 minutes | |
Secondary | 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. | 2 minutes | |
Secondary | 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. | 5 minutes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05559255 -
Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI
|
N/A | |
Completed |
NCT04748367 -
Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care
|
N/A | |
Terminated |
NCT04356352 -
Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain
|
Phase 2/Phase 3 | |
Completed |
NCT05057988 -
Virtual Empowered Relief for Chronic Pain
|
N/A | |
Completed |
NCT04466111 -
Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
|
||
Recruiting |
NCT06206252 -
Can Medical Cannabis Affect Opioid Use?
|
||
Completed |
NCT05868122 -
A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy
|
Phase 3 | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Completed |
NCT03273114 -
Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain
|
N/A | |
Enrolling by invitation |
NCT06087432 -
Is PNF Application Effective on Temporomandibular Dysfunction
|
N/A | |
Completed |
NCT05508594 -
Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001
|
Phase 2/Phase 3 | |
Recruiting |
NCT03646955 -
Partial Breast Versus no Irradiation for Women With Early Breast Cancer
|
N/A | |
Active, not recruiting |
NCT03472300 -
Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
|
||
Completed |
NCT03678168 -
A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries
|
N/A | |
Completed |
NCT03286543 -
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System
|
N/A | |
Completed |
NCT03931772 -
Online Automated Self-Hypnosis Program
|
N/A | |
Completed |
NCT02913027 -
Can We Improve the Comfort of Pelvic Exams?
|
N/A | |
Terminated |
NCT02181387 -
Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor?
|
Phase 4 | |
Recruiting |
NCT06032559 -
Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment
|
Phase 3 | |
Active, not recruiting |
NCT03613155 -
Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care
|