NCT02802839

Brief Summary

Children with Cystic fibrosis (CF) have to undergo several needle-related procedures during outpatient visits or hospital stay. It is common for children with CF to display distress and behavioural problems during invasive procedures. Children with chronic diseases have a lower threshold of pain compared to non-chronic patients. Effective management of needle distress in children with CF is critical. Although pharmacological and non pharmacological methods are used during needle -related procedures to lower painful stimuli nearly all patients with CF experience anxiety. Distraction has been shown to be an effective technique that directs children's attention away from noxious stimuli. The application of Virtual Reality (VR) in the medical field has been shown to be successful already 15 years ago. VR has found its use during the medication of burns and in patients undergoing cancer treatments whereas so far few studies have been published to assess its efficacy in reducing needle related pain and distress in children and none in children with CF. Objectives To assess the efficacy of VR in reducing pain and distress during venipuncture in children with CF compared to routine care. Project description Randomized controlled parallel trial with a 1 to 1 allocation ratio. The use of VR compared to standard care during venipuncture in children with CF (age 6-18 years) attending the outpatient clinic of the CF Centre of Florence will be compared over the period of 1 year. Patients randomly assigned to arm A will use VR during the procedure, those patients assigned to arm B will receive routine care. Anticipated output Determination of the efficacy of VR in lowering pain and distress during venipuncture.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

June 16, 2016

Status Verified

June 1, 2016

Enrollment Period

1 year

First QC Date

June 6, 2016

Last Update Submit

June 13, 2016

Conditions

Cystic Fibrosis

Keywords

Virtual Realityvenipuncture

Outcome Measures

Primary Outcomes (1)

  • Pain

    Vas-Pain scale self administered by the patient and the parent

    30 seconds after the procedure

Secondary Outcomes (2)

  • Anxiety

    before the procedure

  • Distress

    during the procedure

Other Outcomes (3)

  • Distress

    during the procedure

  • Distress

    30 seconds after the procedure

  • Cooperation

    30 seconds after the procedure

Study Arms (2)

Sperimental

EXPERIMENTAL

The patient will be shown the headset for VR and a selection of age appropriate virtual realities to immerge in by the nurse not performing the procedure. There will be two lists of VRs to choose from, one for age 6 to 12 and one for age 12 to 18 with the following themes: amusement rides /carousel, space rides, zoo, safari, dinosaurs, city touring, landscapes, caverns. Once the patient is ready to wear the headset the application will start and 120 seconds later the procedure will take place. The nurse performing venipuncture will be a different one than the one handling distraction. Once the procedure ends the video will last for one more minute or up to the child' s desire. Only the first venipuncture attempt will be observed.

Device: Virtual Reality

Observational

NO INTERVENTION

Control intervention When arriving to the CF centre for routine visit that implies also the taking of blood samples, after having obtained the informed consent, a trained nurse of the CF Centre, will apply to each child recruited -in the presence of the parent, who may hold the child- the anesthetic cream. Only the first venipuncture attempt will be observed.

Interventions

Virtual RealityDEVICE
Sperimental

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • CF diagnosed by at least two sweat test according to Gibson and Cook (Legrys 1996)
  • age from 6 to 18
  • regularly attending the CF centre of Florence
  • who do not wear glasses, do not have amblyopia, who do not have monocular vision
  • who have not taken pain medications in the last 8 hours
  • child's and parent's assent of the informed consent

You may not qualify if:

  • CF not diagnosed not diagnosed according to Gibson and Cook
  • under the age of 6 years and over the age of 18
  • not regularly attending the CF centre of Florence
  • who wear glasses, who have amblyopia, who have a monocular vision
  • who have taken pain medications in the last 8 hours
  • child's or parent's dissent of the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meyer Children Hospital

Florence, 50139, Italy

RECRUITING

Related Publications (5)

  • Duff AJ. Psychological interventions in cystic fibrosis and asthma. Paediatr Respir Rev. 2001 Dec;2(4):350-7. doi: 10.1053/prrv.2001.0171.

    PMID: 12052307RESULT

  • Bisogni S, Dini C, Olivini N, Ciofi D, Giusti F, Caprilli S, Gonzalez Lopez JR, Festini F. Perception of venipuncture pain in children suffering from chronic diseases. BMC Res Notes. 2014 Oct 18;7:735. doi: 10.1186/1756-0500-7-735.

    PMID: 25326685RESULT

  • Ayers S, Muller I, Mahoney L, Seddon P. Understanding needle-related distress in children with cystic fibrosis. Br J Health Psychol. 2011 May;16(Pt 2):329-43. doi: 10.1348/135910710X506895. Epub 2011 Mar 9.

    PMID: 21489060RESULT

  • Sermet-Gaudelus I, De Villartay P, de Dreuzy P, Clairicia M, Vrielynck S, Canoui P, Kirszenbaum M, Singh-Mali I, Agrario L, Salort M, Charron B, Dusser D, Lenoir G, Hubert D. Pain in children and adults with cystic fibrosis: a comparative study. J Pain Symptom Manage. 2009 Aug;38(2):281-90. doi: 10.1016/j.jpainsymman.2008.08.009. Epub 2009 Apr 11.

    PMID: 19364632RESULT

  • Gold JI, Kim SH, Kant AJ, Joseph MH, Rizzo AS. Effectiveness of virtual reality for pediatric pain distraction during i.v. placement. Cyberpsychol Behav. 2006 Apr;9(2):207-12. doi: 10.1089/cpb.2006.9.207.

    PMID: 16640481RESULT

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Filippo Festini, Prof of Nurs

    Univisersity of Florence

    STUDY DIRECTOR

Central Study Contacts

Sofia Bisogni, BSN, PhD

CONTACT

sofia.bisogni@unifi.it

Stella Neri, RN,BSN

CONTACT

sneri197@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nursing

Study Record Dates

First Submitted

June 6, 2016

First Posted

June 16, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

June 16, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)