Venipuncture Clinical Trial
Official title:
Animal Assisted Activity, Clowns and Music for the Reduction of Distress and Pain in Children During Venipuncture
Verified date | July 2019 |
Source | Meyer Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To evaluate the efficacy of Health Support Activities (Animal Assisted Intervention, Clows,
Musicians) in the reduction of pain and distress in children undergoing venipuncture.
Hypothesis: the investigators expect a reduction in in pain and distress.
Status | Completed |
Enrollment | 600 |
Est. completion date | April 30, 2019 |
Est. primary completion date | April 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 12 Years |
Eligibility |
Inclusion Criteria: - outpatients - scheduled to venipuncture - Italian speaking Exclusion Criteria: - cognitive and/or developmental impairment |
Country | Name | City | State |
---|---|---|---|
Italy | Meyer Children's Hospital | Firenze |
Lead Sponsor | Collaborator |
---|---|
Meyer Children's Hospital |
Italy,
Bijttebier P, Vertommen H. The Impact of Previous Experience on Children's Reactions to Venepunctures. J Health Psychol. 1998 Jan;3(1):39-46. doi: 10.1177/135910539800300103. — View Citation
Birnie KA, Noel M, Chambers CT, Uman LS, Parker JA. Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Database Syst Rev. 2018 Oct 4;10:CD005179. doi: 10.1002/14651858.CD005179.pub4. — View Citation
Caprilli S, Anastasi F, Grotto RP, Scollo Abeti M, Messeri A. Interactive music as a treatment for pain and stress in children during venipuncture: a randomized prospective study. J Dev Behav Pediatr. 2007 Oct;28(5):399-403. Erratum in: J Dev Behav Pediatr. 2009 Jun;30(3):254. Abeti, Mariana Scollo [corrected to Scollo Abeti, Marianna]. — View Citation
Duff AJ. Incorporating psychological approaches into routine paediatric venepuncture. Arch Dis Child. 2003 Oct;88(10):931-7. Review. — View Citation
Goodenough B, Thomas W, Champion GD, Perrott D, Taplin JE, von Baeyer CL, Ziegler JB. Unravelling age effects and sex differences in needle pain: ratings of sensory intensity and unpleasantness of venipuncture pain by children and their parents. Pain. 1999 Mar;80(1-2):179-90. — View Citation
Kaminsky M. (2002). Play and Pets: The Physical and Emotional Impact of Child-Life and Pet Theraphy on Hospitalized Children. Children's Health Care, 31(4), 321-335.
Kennedy RM, Luhmann J, Zempsky WT. Clinical implications of unmanaged needle-insertion pain and distress in children. Pediatrics. 2008 Nov;122 Suppl 3:S130-3. doi: 10.1542/peds.2008-1055e. Review. — View Citation
Kolk AM, van Hoof R, Fiedeldij Dop MJ. Preparing children for venepuncture. The effect of an integrated intervention on distress before and during venepuncture. Child Care Health Dev. 2000 May;26(3):251-60. — View Citation
Meiri N, Ankri A, Hamad-Saied M, Konopnicki M, Pillar G. The effect of medical clowning on reducing pain, crying, and anxiety in children aged 2-10 years old undergoing venous blood drawing--a randomized controlled study. Eur J Pediatr. 2016 Mar;175(3):373-9. doi: 10.1007/s00431-015-2652-z. Epub 2015 Oct 16. — View Citation
Treurnicht Naylor K, Kingsnorth S, Lamont A, McKeever P, Macarthur C. The effectiveness of music in pediatric healthcare: a systematic review of randomized controlled trials. Evid Based Complement Alternat Med. 2011;2011:464759. doi: 10.1155/2011/464759. Epub 2010 Sep 30. — View Citation
Tsao JC, Lu Q, Myers CD, Kim SC, Turk N, Zeltzer LK. Parent and child anxiety sensitivity: relationship to children's experimental pain responsivity. J Pain. 2006 May;7(5):319-26. — View Citation
Uman LS, Birnie KA, Noel M, Parker JA, Chambers CT, McGrath PJ, Kisely SR. Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Database Syst Rev. 2013 Oct 10;(10):CD005179. doi: 10.1002/14651858.CD005179.pub3. Review. Update in: Cochrane Database Syst Rev. 2018 Oct 04;10:CD005179. — View Citation
Uman LS, Chambers CT, McGrath PJ, Kisely S. Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD005179. Review. Update in: Cochrane Database Syst Rev. 2013;10:CD005179. — View Citation
Vagnoli L, Caprilli S, Vernucci C, Zagni S, Mugnai F, Messeri A. Can presence of a dog reduce pain and distress in children during venipuncture? Pain Manag Nurs. 2015 Apr;16(2):89-95. doi: 10.1016/j.pmn.2014.04.004. Epub 2014 Nov 4. — View Citation
Wolyniez I, Rimon A, Scolnik D, Gruber A, Tavor O, Haviv E, Glatstein M. The effect of a medical clown on pain during intravenous access in the pediatric emergency department: a randomized prospective pilot study. Clin Pediatr (Phila). 2013 Dec;52(12):1168-72. doi: 10.1177/0009922813502257. Epub 2013 Sep 11. — View Citation
Yoo H, Kim S, Hur HK, Kim HS. The effects of an animation distraction intervention on pain response of preschool children during venipuncture. Appl Nurs Res. 2011 May;24(2):94-100. doi: 10.1016/j.apnr.2009.03.005. Epub 2009 Jul 15. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Distress | Brief Behavioral Distress Scale - BBDS is an observational measure that assess children's procedure-related distress with 12 discrete component steps involved in venipuncture, in order to observe specific demands for compliance on the child during the procedure. Observers record the occurrence or nonoccurrence of the target behaviors during each step. Operational definitions of the target behaviors for each category are: 1) Non interfering Distress Behaviors; 2) Potentially Interfering Distress Behaviors; 3) Interfering Distress Behaviors. The number of steps in which a behavior occur is summed and divided by the total number of steps, then multiplied by 100 to yield percentage of steps with occurrence scores for each behavioral category. The number of steps in which behaviors from any of the three distress behavior categories occur is summed and divided by the total number of steps multiplied by three, then multiplied by 100 to obtain the Total Distress Score. | Distress assessment is one for every participant and begins when child enter in the venipuncture room and lasts until the child exit the venipuncture room, in the day of recruitment. . | |
Primary | Pain perception 3-6 years old | Numerical scales, based on age, Wong Baker Scale. The Wong Baker Faces Pain Rating Scale (Wong & Baker, 1998) is a self-report scale for children older than 3 years old, that shows a sequence of faces ranging from a happy face at 0 level, that means "No hurt", to a crying face at 10th level, that means "Hurts worst". | Pain assessment is one for every participant, measured immediately after the child exit the venipuncture room, in the day of recruitment | |
Primary | Pain perception from 7 years old | Numerical scale, Visual Analogue Scale - VAS. VAS is used from the age of 7 years old, is a self-report numerical scale ranging from 0, that means "No pain", to 10, that means "worst pain". | Pain assessment is one for every participant, measured immediately after the child exit the venipuncture room, in the day of recruitment | |
Secondary | Parent's state and trait anxiety | Self-report scale (State-Trait Anxiety Inventory - STAI). The STAI is a self-report anxiety behavioral instrument for adults. It consists of two separate subscales: one assessing trait anxiety (baseline, Y1), the other assessing the state anxiety (situational, Y2). Each subscale is composed by 20 items, rated on a 4-points Likert scale and separately analyzed. Total score for each subscale range from 20 to 80, with higher scores denoting higher levels of anxiety. | Parent's anxiety assessment is one for every participant, measured in the waiting room before child enters in the venipuncture room, in the day of recruitment |
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