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The Effect of Pre Surgery Dog Visits on Post Surgery Consumption of Pain Medication

This study has been withdrawn prior to recruitment.
( PI left university. Did not start study )

Sponsored by: Oklahoma State University Center for Health Sciences
Information provided by: Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier: NCT00452738
  Purpose

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.


Condition Intervention
Post Tonsillectomy Pain
Behavioral: Therapy dog
Behavioral: Costumed character
Behavioral: Parents-only

MedlinePlus related topics:   Anxiety   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:   The Effect of Pre Surgery Dog Visits on Post Surgery Consumption of Pain Medication

Further study details as provided by Oklahoma State University Center for Health Sciences:

Primary Outcome Measures:
  • Bieri Faces Scale upon arrival, after intervention, and at discharge
  • Modified Yale Preoperative Anxiety Scale upon arrival, after intervention, and in surgical preparation room

Estimated Enrollment:   90
Study Start Date:   April 2007
Estimated Study Completion Date:   February 2008

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.

  Eligibility
Ages Eligible for Study:   4 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00452738

Locations
United States, Oklahoma
Oklahoma State University Surgi-Center    
      Tulsa, Oklahoma, United States, 74107

Sponsors and Collaborators
Oklahoma State University Center for Health Sciences

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    
  More Information


Publications of Results:
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, L. G. (2002). Pet therapy. Concise Reviews of Pediatric Infectious Diseases, 21, 64-66.
 
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., 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.
 
Melson, G. F. (2001). Why The Wild Things Are. Harvard University Press. Cambridge: MA.
 
Schantz, (1990). Reviews and research reports; Preventing potential health hazards incidental to the use of pets in therapy. Anthrozoos, 4(1), 114-123.
 

Other Publications:
Bieri D, Reeve RA, Champion GD, 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):139-50.
 
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. Review.
 
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. Epub 2006 Apr 2.
 
Feld LH, Negus JB, White PF. Oral midazolam preanesthetic medication in pediatric outpatients. Anesthesiology. 1990 Nov;73(5):831-4.
 
Fry WF Jr. The physiologic effects of humor, mirth, and laughter. JAMA. 1992 Apr 1;267(13):1857-8. No abstract available.
 
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.
 
Johnson RA, Odendaal JS, Meadows RL. Animal-assisted interventions research: issues and answers. West J Nurs Res. 2002 Jun;24(4):422-40. Review.
 
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.
 
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.
 
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.
 
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.
 
Odendaal JS. Animal-assisted therapy - magic or medicine? J Psychosom Res. 2000 Oct;49(4):275-80. Review.
 
Peterson L, Ridley-Johnson R. Pediatric hospital response to survey on prehospital preparation for children. J Pediatr Psychol. 1980 Mar;5(1):1-7. No abstract available.
 
Piaget, J. (1952). The origins of intelligence in children. International Universities Press. New York: NY.
 
Riffenburgh, R. H. (2006). Sample Size Required in a Study. In Statistics in Medicine, (pp. 397-417). Elsevier Academic Press, San Diego: CA Roosevelt, M. (2001). Canine candy stripers. Time, 158(5), 52-54.
 
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.
 
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.
 
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.
 
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.
 
Weisenberg M, Raz T, Hener T. The influence of film-induced mood on pain perception. Pain. 1998 Jun;76(3):365-75.
 

Study ID Numbers:   2006036
First Received:   March 23, 2007
Last Updated:   January 22, 2008
ClinicalTrials.gov Identifier:   NCT00452738
Health Authority:   United States: Institutional Review Board

Keywords provided by Oklahoma State University Center for Health Sciences:
animal-assisted intervention  
pre surgery anxiety  
post surgery pain medication consumption  

Study placed in the following topic categories:
Pain

ClinicalTrials.gov processed this record on October 20, 2008




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