Support Activities for the Reduction of Distress and Pain in Children During Venipuncture

NCT03899766 | Completed

• 1 other identifier: SupportActivities_Venipuncture
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Venipuncture

Keywords

pain, procedural; child; anxiety

Outcome Measures

Primary Outcomes (3)

• 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. .

• 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

• 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 Outcomes (1)

• Parent's state and trait 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

Study Arms (4)

Animal Assisted Intervention

children interact and play with the expert of Animal Assisted Intervention (AAI) and his/her trained dog in the waiting room and then, are accompanied by a parent (as standard care) and the AAI in the venipuncture room during and immediately after the procedure

Other: Animal Assisted Intervention

Clowns

children interact and play with hospital clowns in the waiting room and then, are accompanied by a parent (as standard care) and the clown in the venipuncture room during and immediately after the procedure

Other: Clowns

Musicians

children interact and play with a musician in the waiting room and then, are accompanied by a parent (as standard care) and the musician in the venipuncture room during and immediately after the procedure

Other: Musicians

Non-clinical Conversation

children are accompanied by a parent in the waiting room and then in the venipuncture room during the procedure, thus receiving standard care

Interventions

Animal Assisted Intervention OTHER

Operators of AAI and their dog meet the child and his/her parent in the waiting room and facilitates interaction using their professional characteristics. The interaction continue in the venipuncture room during the procedure and at its conclusion; in fact, the operators accompany the child and his/her parent outside the venipuncture room, to not abruptly interrupt the interaction.

Animal Assisted Intervention

Clowns OTHER

Hospital clowns meet the child and his/her parent in the waiting room and facilitates interaction using their professional characteristics. The interaction continue in the venipuncture room during the procedure and at its conclusion; in fact, the operators accompany the child and his/her parent outside the venipuncture room, to not abruptly interrupt the interaction.

Clowns

Musicians OTHER

Musicians meet the child and his/her parent in the waiting room and facilitates interaction using their professional characteristics. The interaction continue in the venipuncture room during the procedure and at its conclusion; in fact, the operators accompany the child and his/her parent outside the venipuncture room, to not abruptly interrupt the interaction.

Musicians

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Outpatiens reffering to hospital for venipuncture

You may qualify if:

• outpatients
• scheduled to venipuncture
• Italian speaking

You may not qualify if:

• cognitive and/or developmental impairment

Sponsors & Collaborators

• Meyer Children's Hospital IRCCS: lead

Study Sites (1)

Meyer Children's Hospital

Florence, 50139, Italy

Location

Related Publications (16)

• 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.

  PMID: 22021341 BACKGROUND

• 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. doi: 10.1097/DBP.0b013e31811ff8a7.

  PMID: 18049324 BACKGROUND

• Duff AJ. Incorporating psychological approaches into routine paediatric venepuncture. Arch Dis Child. 2003 Oct;88(10):931-7. doi: 10.1136/adc.88.10.931.

  PMID: 14500318 BACKGROUND

• 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. doi: 10.1016/s0304-3959(98)00201-2.

  PMID: 10204730 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 18978006 BACKGROUND

• 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. doi: 10.1046/j.1365-2214.2000.00145.x.

  PMID: 10921442 BACKGROUND

• 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.

  PMID: 26475347 BACKGROUND

• 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.

  PMID: 20976017 BACKGROUND

• 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. doi: 10.1016/j.jpain.2005.12.004.

  PMID: 16632321 BACKGROUND

• 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.

  PMID: 24108531 BACKGROUND

• 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. doi: 10.1002/14651858.CD005179.pub2.

  PMID: 17054243 BACKGROUND

• 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(10):CD005179. doi: 10.1002/14651858.CD005179.pub4.

  PMID: 30284240 BACKGROUND

• 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.

  PMID: 25439114 BACKGROUND

• 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.

  PMID: 24028842 BACKGROUND

• 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.

  PMID: 20974061 BACKGROUND

MeSH Terms

Conditions

Pain, Procedural; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Andrea Messeri, MD

  Meyer Children's Hospital IRCCS

  STUDY DIRECTOR

• Laura Vagnoli, MSc

  Meyer Children's Hospital IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 24, 2018
• First Posted: April 2, 2019
• Study Start: February 12, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 30, 2019
• Last Updated: July 18, 2019

Record last verified: 2019-07

Locations

IT (1)