- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00452738
The Effect of Pre Surgery Dog Visits on Post Surgery Consumption of Pain Medication (Dog)
April 20, 2015 updated by: Oklahoma State University Center for Health Sciences
The objective of this study is to examine the effects of pre surgery dog visits as compared to a costumed character or parents-only on the consumption of pain medication after surgery.
It is hypothesized that pre surgery dog visits will reduce post surgical stress and anxiety.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
Recent research has revealed that children who are highly anxious prior to surgery experienced more problems post surgery.
These problems included reporting of more pain and requested more pain medication during hospitalization and home follow up.
Consumption of pain medication may not be the optimal pain management program.
In contrast, numerous human-animal interaction studies have shown that animals tend to have a calming effect on people, reduce stress, and lesson anxiety.
Therefore, the primary objective of this study is to examine the effect of pre surgery dog visits as compared to a costumed character or parents-only on the consumption of pain medication after surgery.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oklahoma
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Tulsa, Oklahoma, United States, 74107
- Oklahoma State University Surgi-Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 7 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Tonsillectomy and Adenoidectomy (T/A)
- 4-7 years old
- Prescribed codeine and/or analgesics for postoperative pain
Exclusion Criteria:
- Participant must not be afraid of dogs, or allergic to animal dander
- Chronic medical conditions other than T/A
- Developmentally delayed
- On psychotropic medications
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Bieri Faces Scale upon arrival, after intervention, and at discharge
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Modified Yale Preoperative Anxiety Scale upon arrival, after intervention, and in surgical preparation room
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sherril M Stone, PhD, Oklahoma State University Center for Health Sciences
- Principal Investigator: Stan Sherman, DO, Oklahoma State University Center for Health Sciences
- Principal Investigator: Chaunda Capers, BS, Oklahoma State University Center for Health Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bieri D, Reeve RA, Champion DG, Addicoat L, Ziegler JB. The Faces Pain Scale for the self-assessment of the severity of pain experienced by children: development, initial validation, and preliminary investigation for ratio scale properties. Pain. 1990 May;41(2):139-150. doi: 10.1016/0304-3959(90)90018-9.
- Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920.
- Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012.
- Vagnoli L, Caprilli S, Robiglio A, Messeri A. Clown doctors as a treatment for preoperative anxiety in children: a randomized, prospective study. Pediatrics. 2005 Oct;116(4):e563-7. doi: 10.1542/peds.2005-0466.
- Fry WF Jr. The physiologic effects of humor, mirth, and laughter. JAMA. 1992 Apr 1;267(13):1857-8. doi: 10.1001/jama.267.13.1857. No abstract available.
- Kain ZN, Caldwell-Andrews AA, Krivutza DM, Weinberg ME, Gaal D, Wang SM, Mayes LC. Interactive music therapy as a treatment for preoperative anxiety in children: a randomized controlled trial. Anesth Analg. 2004 May;98(5):1260-6, table of contents. doi: 10.1213/01.ane.0000111205.82346.c1.
- Viitanen H, Annila P, Viitanen M, Tarkkila P. Premedication with midazolam delays recovery after ambulatory sevoflurane anesthesia in children. Anesth Analg. 1999 Jul;89(1):75-9. doi: 10.1097/00000539-199907000-00014.
- Sobo EJ, Eng B, Kassity-Krich N. Canine visitation (pet) therapy: pilot data on decreases in child pain perception. J Holist Nurs. 2006 Mar;24(1):51-7. doi: 10.1177/0898010105280112.
- Brodie SJ, Biley FC, Shewring M. An exploration of the potential risks associated with using pet therapy in healthcare settings. J Clin Nurs. 2002 Jul;11(4):444-56. doi: 10.1046/j.1365-2702.2002.00628.x.
- Caprilli S, Messeri A. Animal-Assisted Activity at A. Meyer Children's Hospital: A Pilot Study. Evid Based Complement Alternat Med. 2006 Sep;3(3):379-83. doi: 10.1093/ecam/nel029. Epub 2006 Apr 2.
- Center for Disease Control (CDC) (2006). Hand Sanitizer Alert. www.cdc.gov/ncidod/eid/vol12no03/05-0955.htm.
- Delta Society (2006). About Animal-assisted activities & Animal-assisted therapy. www.deltasociety.org/AnimalsAAAAbout.htm.
- Denver Children's Hospital. (1990). Facts: Prescription pet program. Denver, CO: Author.
- Feld LH, Negus JB, White PF. Oral midazolam preanesthetic medication in pediatric outpatients. Anesthesiology. 1990 Nov;73(5):831-4. doi: 10.1097/00000542-199011000-00006.
- Golden L, Pagala M, Sukhavasi S, Nagpal D, Ahmad A, Mahanta A. Giving toys to children reduces their anxiety about receiving premedication for surgery. Anesth Analg. 2006 Apr;102(4):1070-2. doi: 10.1213/01.ane.0000198332.51475.50.
- Green Chimneys (2006). www.greenchimneys.com/about.htm.
- Johnson RA, Odendaal JS, Meadows RL. Animal-assisted interventions research: issues and answers. West J Nurs Res. 2002 Jun;24(4):422-40. doi: 10.1177/01945902024004009.
- Kain ZN, Mayes LC, Caramico LA, Silver D, Spieker M, Nygren MM, Anderson G, Rimar S. Parental presence during induction of anesthesia. A randomized controlled trial. Anesthesiology. 1996 May;84(5):1060-7. doi: 10.1097/00000542-199605000-00007.
- Moody WJ, King R, O'Rourke S. Attitudes of paediatric medical ward staff to a dog visitation programme. J Clin Nurs. 2002 Jul;11(4):537-44. doi: 10.1046/j.1365-2702.2002.00618.x.
- Odendaal JS. Animal-assisted therapy - magic or medicine? J Psychosom Res. 2000 Oct;49(4):275-80. doi: 10.1016/s0022-3999(00)00183-5.
- Peterson L, Ridley-Johnson R. Pediatric hospital response to survey on prehospital preparation for children. J Pediatr Psychol. 1980 Mar;5(1):1-7. doi: 10.1093/jpepsy/5.1.1. No abstract available.
- Piaget, J. (1952). The origins of intelligence in children. International Universities Press. New York: NY.
- Roosevelt M. Canine candy stripers. Time. 2001 Aug 6;158(5):52-3. No abstract available.
- Saint Mary's Hospital. (1995). Pet therapy on PEDS unit: Happiness is a warm puppy. Rochester: MN.
- Santrock, John W. (2001). Child development. Ninth Edition, 2, 36-37.
- Serpell, J. A. (2000). Creatures of the unconscious: Companion animals as mediators. In A. L. Podberscek, E. S. Paul & J. A. Serpall (Eds.), Companion animals and us: Exploring the relationship between people and pets (pp. 108-124). New York: Cambridge University Press.
- Spielberger C. D. (1983). Manual for the State-Trait Anxiety Inventory (STAI: Form Y), Consulting Psychologists Press, Palo Alto: CA.
- Weisenberg M, Raz T, Hener T. The influence of film-induced mood on pain perception. Pain. 1998 Jun;76(3):365-375. doi: 10.1016/S0304-3959(98)00069-4.
- Arkow, P. (1993). Pet therapy: A study and resource guide for the use of companion animals in selected therapies (7th ed.). Humane Society of the Pikes Peak Region. Colorado Springs: CO
- Barba, B. (1995). A critical review of research on the human/companion animal relationship 1988-1993. Anthrozoos, 8(1), 9-15.
- Bell, J. R. (2006). Visitation dogs carry C. difficile, MRSA, Salmonella. Family Practice News, 28.
- Donowitz LG. Pet therapy. Pediatr Infect Dis J. 2002 Jan;21(1):64-6. doi: 10.1097/00006454-200201000-00016. No abstract available.
- Friedman, E., Thomas, S. A., & Eddy, T. J. (2000). Companion animals and human health: Physical and cardiovascular influences. In A. L. Podberscek, E. S. Paul, & J. A. Serpell (Eds), Companion animals and use: Exploring the relationship between people and pets (pp. 125-142). New York: Cambridge University Press.
- Jalongo, M. R. (2004). The world's children and their companion animals: Developmental and educational significance of the child/pet bond. Association for Childhood Education International. Olney: ND.
- Jalongo, M. R., Astorino, T., & Bomboy, N. (2004). Canine Visitors: The Influence of therapy Dogs on Young Children's Learning and Well-Being in Classrooms and Hospitals. Early Childhood Education Journal, 32(1), 9-16.
- Kaminski, M., Pellino, T., & Wish, J. (2002). Play and Pets: The Physical and Emotional Impact of Child-Life and Pet Therapy on Hospitalized Children. Children's Health Care, 31(4), 321-335.
- Mallon, G. (1994). Some of our best therapists are dogs. Child and Youth Care Forum, 23, 89-101.
- Melson, G. F. (2001). Why The Wild Things Are. Harvard University Press. Cambridge: MA.
- Pembrook, L. (2005). Distraction with handheld video game is an effective anxiolytic, Anesthesiology News, 31(3), 4-6.
- Schantz, (1990). Reviews and research reports; Preventing potential health hazards incidental to the use of pets in therapy. Anthrozoos, 4(1), 114-123.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Study Completion (Anticipated)
February 1, 2008
Study Registration Dates
First Submitted
March 23, 2007
First Submitted That Met QC Criteria
March 26, 2007
First Posted (Estimate)
March 27, 2007
Study Record Updates
Last Update Posted (Estimate)
April 21, 2015
Last Update Submitted That Met QC Criteria
April 20, 2015
Last Verified
January 1, 2008
More Information
Terms related to this study
Other Study ID Numbers
- 2006036
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.