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

Post Tonsillectomy Pain Clinical Trial

— Dog  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00452738
• Other study ID #: 2006036
• Status: Withdrawn
• Phase: N/A
• First received: March 23, 2007
• Last updated: April 20, 2015
• Start date: April 2007
• Est. completion date: February 2008

Study information

• Verified date: January 2008
• Source: Oklahoma State University Center for Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 7 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post Tonsillectomy Pain

Intervention

Behavioral:
• Therapy dog

• Costumed character

• Parents-only

Locations

Country	Name	City	State
United States	Oklahoma State University Surgi-Center	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Oklahoma State University Center for Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (40)

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.

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. — View Citation

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. — View Citation

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. — View Citation

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.

Donowitz LG. Pet therapy. Pediatr Infect Dis J. 2002 Jan;21(1):64-6. — View Citation

Feld LH, Negus JB, White PF. Oral midazolam preanesthetic medication in pediatric outpatients. Anesthesiology. 1990 Nov;73(5):831-4. — View Citation

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

Fry WF Jr. The physiologic effects of humor, mirth, and laughter. JAMA. 1992 Apr 1;267(13):1857-8. — View Citation

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. — View Citation

Green Chimneys (2006). www.greenchimneys.com/about.htm.

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.

Johnson RA, Odendaal JS, Meadows RL. Animal-assisted interventions research: issues and answers. West J Nurs Res. 2002 Jun;24(4):422-40. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

Odendaal JS. Animal-assisted therapy - magic or medicine? J Psychosom Res. 2000 Oct;49(4):275-80. Review. — View Citation

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

Peterson L, Ridley-Johnson R. Pediatric hospital response to survey on prehospital preparation for children. J Pediatr Psychol. 1980 Mar;5(1):1-7. — View Citation

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.

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.

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

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. — View Citation

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

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. — View Citation

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. — View Citation

Weisenberg M, Raz T, Hener T. The influence of film-induced mood on pain perception. Pain. 1998 Jun;76(3):365-75. — View Citation

* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bieri Faces Scale upon arrival, after intervention, and at discharge
Primary	Modified Yale Preoperative Anxiety Scale upon arrival, after intervention, and in surgical preparation room