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Post Tonsillectomy PainDogNCT00452738

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

A study testing Therapy dog, Costumed character and Parents-only in people with Post Tonsillectomy Pain, run by Oklahoma State University Center for Health Sciences at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 4 to 7 years
Conditions the study is for
Post Tonsillectomy Pain
What is being tested?
Therapy dog, Costumed character and Parents-only
How many people
0 participants
Where
1 siteUnited States
Study dates
Apr 2007to Feb 2008
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 7 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Tonsillectomy and Adenoidectomy (T/A)
  • 4-7 years old
  • Prescribed codeine and/or analgesics for postoperative pain

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Oklahoma State University Surgi-Center

    Tulsa, Oklahoma, 74107

Other trials in United States

About this study

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.

Read the 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.

Being tested
Therapy dog, Costumed character, Parents-only
Keywords
animal-assisted intervention, pre surgery anxiety, post surgery pain medication consumption

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Therapy dogBehavioural

  • Costumed characterBehavioural

  • Parents-onlyBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bieri Faces Scale upon arrival, after intervention, and at discharge

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2007 (estimated)
  2. Study startApr 2007
  3. Study completionFeb 2008 (estimated)

Why it stopped: PI left university. Did not start study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00452738
Sponsor's protocol ID
2006036
Acronym
Dog
Status last verified
Jan 2008
First submitted
23 Mar 2007
Last updated
21 Apr 2015
Results posted
No
Data monitoring committee
No

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.

    PubMed 2367140

  • 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.

    PubMed 12100640

  • 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.

    PubMed 16951723

  • 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.

    PubMed 2240672

  • 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.

    PubMed 1545471

  • 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.

    PubMed 16551900

  • 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.

    PubMed 12035914

  • 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.

    PubMed 16882820

  • 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.

    PubMed 8623999

  • 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.

    PubMed 15105197

  • 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.

    PubMed 9322455

Questions about this trial

What is this clinical trial studying?

A study testing Therapy dog, Costumed character and Parents-only in people with Post Tonsillectomy Pain, run by Oklahoma State University Center for Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bieri Faces Scale upon arrival, after intervention, and at discharge. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00452738, which also lists 40 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2015.

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