NCT00452738

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2007

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

April 21, 2015

Status Verified

January 1, 2008

First QC Date

March 23, 2007

Last Update Submit

April 20, 2015

Conditions

Keywords

animal-assisted interventionpre surgery anxietypost surgery pain medication consumption

Outcome Measures

Primary Outcomes (2)

  • Bieri Faces Scale upon arrival, after intervention, and at discharge

  • Modified Yale Preoperative Anxiety Scale upon arrival, after intervention, and in surgical preparation room

Interventions

Therapy dogBEHAVIORAL
Parents-onlyBEHAVIORAL

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Tonsillectomy and Adenoidectomy (T/A)
  • years old
  • Prescribed codeine and/or analgesics for postoperative pain

You may not qualify if:

  • Participant must not be afraid of dogs, or allergic to animal dander
  • Chronic medical conditions other than T/A
  • Developmentally delayed
  • On psychotropic medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oklahoma State University Surgi-Center

Tulsa, Oklahoma, 74107, United States

Location

Related Publications (40)

  • 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.

    PMID: 2367140BACKGROUND
  • 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.

    PMID: 12100640BACKGROUND
  • 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.

    PMID: 16951723BACKGROUND
  • Center for Disease Control (CDC) (2006). Hand Sanitizer Alert. www.cdc.gov/ncidod/eid/vol12no03/05-0955.htm.

    BACKGROUND
  • Delta Society (2006). About Animal-assisted activities & Animal-assisted therapy. www.deltasociety.org/AnimalsAAAAbout.htm.

    BACKGROUND
  • Denver Children's Hospital. (1990). Facts: Prescription pet program. Denver, CO: Author.

    BACKGROUND
  • 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.

    PMID: 2240672BACKGROUND
  • 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.

    PMID: 1545471BACKGROUND
  • 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.

    PMID: 16551900BACKGROUND
  • Green Chimneys (2006). www.greenchimneys.com/about.htm.

    BACKGROUND
  • 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.

    PMID: 12035914BACKGROUND
  • 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.

    PMID: 16882820BACKGROUND
  • 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.

    PMID: 8623999BACKGROUND
  • 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.

    PMID: 15105197BACKGROUND
  • 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.

    PMID: 9322455BACKGROUND
  • 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.

    PMID: 12100650BACKGROUND
  • 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.

    PMID: 11119784BACKGROUND
  • 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.

    PMID: 7452418BACKGROUND
  • Piaget, J. (1952). The origins of intelligence in children. International Universities Press. New York: NY.

    BACKGROUND
  • Roosevelt M. Canine candy stripers. Time. 2001 Aug 6;158(5):52-3. No abstract available.

    PMID: 11499222BACKGROUND
  • Saint Mary's Hospital. (1995). Pet therapy on PEDS unit: Happiness is a warm puppy. Rochester: MN.

    BACKGROUND
  • Santrock, John W. (2001). Child development. Ninth Edition, 2, 36-37.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 16449747BACKGROUND
  • Spielberger C. D. (1983). Manual for the State-Trait Anxiety Inventory (STAI: Form Y), Consulting Psychologists Press, Palo Alto: CA.

    BACKGROUND
  • 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.

    PMID: 16199685BACKGROUND
  • 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.

    PMID: 10389782BACKGROUND
  • 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.

    PMID: 9718255BACKGROUND
  • 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

    RESULT
  • Barba, B. (1995). A critical review of research on the human/companion animal relationship 1988-1993. Anthrozoos, 8(1), 9-15.

    RESULT
  • Bell, J. R. (2006). Visitation dogs carry C. difficile, MRSA, Salmonella. Family Practice News, 28.

    RESULT
  • 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.

    RESULT
  • 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.

    RESULT
  • 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.

    RESULT
  • 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.

    RESULT
  • Mallon, G. (1994). Some of our best therapists are dogs. Child and Youth Care Forum, 23, 89-101.

    RESULT
  • Melson, G. F. (2001). Why The Wild Things Are. Harvard University Press. Cambridge: MA.

    RESULT
  • Pembrook, L. (2005). Distraction with handheld video game is an effective anxiolytic, Anesthesiology News, 31(3), 4-6.

    RESULT
  • Schantz, (1990). Reviews and research reports; Preventing potential health hazards incidental to the use of pets in therapy. Anthrozoos, 4(1), 114-123.

    RESULT

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 23, 2007

First Posted

March 27, 2007

Study Start

April 1, 2007

Study Completion

February 1, 2008

Last Updated

April 21, 2015

Record last verified: 2008-01

Locations