Comparison of the Effectiveness of Distraction

NCT04983303 | Unknown

• 1 other identifier: SRS
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

Venipuncture, a frequently performed needle-related procedure, is one of the foremost frightening experiences, and a typical source of moderate to severe pain for pediatric patients. No randomized studies have compared the effectiveness of balloon inflation, cough trick, and TICK-B on reducing pain in children between 6 and 12 years old during the drawing of venous blood samples. The research hypothesis was that children who draw and color a picture, inflate a balloon, or perform the cough trick while having their blood taken would experience less pain and anxiety than children who did not undergo a pain-reducing intervention. Objectives: To evaluate the roles of the TICK-B, balloon inflation, and cough trick in relieving pain and fear of school-age children during venipuncture. To compare the effect of TICK-B with the effects of the cough trick, balloon inflation, on reducing pain and anxiety during venipuncture in children. To compare the effects of three distraction groups with the control group in relieving pain and anxiety during venipuncture.

Conditions

Venipuncture

Outcome Measures

Primary Outcomes (2)

• Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain

  To assess the intensity of pain related to the venipuncture procedure in children. Children will self-report their pain severity using the Faces Pain Scale-Revised, which has been validated and shown to be reliable.

  5 minutes before procedure done.

• Fear

  To assess the fear level of the children related to the venipuncture procedure. Children will self-report their level of fear using the Children's Fear Scale (CFS), which has been validated and shown to be reliable.

  5 minutes before venipuncture procedure done

Secondary Outcomes (4)

• Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain

  0 minute during venipuncture procedure (time during insertion of cannula).

• Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain.

  1-2 minute after venipuncture procedure done.

• Children's Fear Scale (CFS): Fear (0-4) no anxiety to extreme anxiety

  0 minute during venipuncture procedure.

• Children's Fear Scale (CFS): Fear (0-4) no anxiety to extreme anxiety

  1-2 minute after venipuncture procedure done.

Other Outcomes (1)

• Visual Analog Scale (VAS), to measure the pain and Fear of children by the parents and observer.

  Immediately after venipuncture (1-2 min.)

Study Arms (4)

TICK-B group as intervention group

EXPERIMENTAL

TICK-B group: The children will receive a picture as they want. They will be asked to trace and color the pictures that need coloring. After the procedure, the child will take his or her picture which he colored during the procedure.

Other: TICK-B group

Coughing trick

EXPERIMENTAL

Coughing trick: Children in this group will be taught how to cough during the procedure. coughs with start moderate force and then coughs again which coincides with a needle procedure, such as venipuncture for example.

Other: TICK-B group

Balloon inflation group as intervention group

EXPERIMENTAL

Balloon inflation group: In this group, the children will receive a balloon colored as their favorite, and they will be asked to inflate the balloon before starting the venipuncture procedure.

Other: TICK-B group

Standard care provided group as control group

NO INTERVENTION

Standard care provided group as the control group

Interventions

TICK-B group OTHER

These interventions will distract the child during venipuncture

Also known as: Coughing trick group, Balloon inflation group, Control group or no intervention

Balloon inflation group as intervention group; Coughing trick; TICK-B group as intervention group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• School-aged 6-12 years old.
• Children who require venipuncture.

You may not qualify if:

• Respiratory chronic diseases,
• Physical impairment,
• Disability contributing to difficult communication,
• Children of unsatisfied parents,
• Children with neurodevelopment delay,
• Cognitive impairment, hearing impairment or a visual impairment,
• Taking an analgesic within 6 hours, or for those with a syncope history.

Sponsors & Collaborators

• University of Witten/Herdecke: lead

Related Publications (8)

• Stevens BJ, Abbott LK, Yamada J, Harrison D, Stinson J, Taddio A, Barwick M, Latimer M, Scott SD, Rashotte J, Campbell F, Finley GA; CIHR Team in Children's Pain. Epidemiology and management of painful procedures in children in Canadian hospitals. CMAJ. 2011 Apr 19;183(7):E403-10. doi: 10.1503/cmaj.101341. Epub 2011 Apr 4.

  PMID: 21464171 BACKGROUND

• Walther-Larsen S, Pedersen MT, Friis SM, Aagaard GB, Romsing J, Jeppesen EM, Friedrichsdorf SJ. Pain prevalence in hospitalized children: a prospective cross-sectional survey in four Danish university hospitals. Acta Anaesthesiol Scand. 2017 Mar;61(3):328-337. doi: 10.1111/aas.12846. Epub 2016 Dec 29.

  PMID: 28032329 BACKGROUND

• Taddio A, Appleton M, Bortolussi R, Chambers C, Dubey V, Halperin S, Hanrahan A, Ipp M, Lockett D, MacDonald N, Midmer D, Mousmanis P, Palda V, Pielak K, Riddell RP, Rieder M, Scott J, Shah V. Reducing the pain of childhood vaccination: an evidence-based clinical practice guideline (summary). CMAJ. 2010 Dec 14;182(18):1989-95. doi: 10.1503/cmaj.092048. Epub 2010 Nov 22. No abstract available.

  PMID: 21098067 BACKGROUND

• Rogers TL, Ostrow CL. The use of EMLA cream to decrease venipuncture pain in children. J Pediatr Nurs. 2004 Feb;19(1):33-9. doi: 10.1016/j.pedn.2003.09.005.

  PMID: 14963868 BACKGROUND

• Koller D, Goldman RD. Distraction techniques for children undergoing procedures: a critical review of pediatric research. J Pediatr Nurs. 2012 Dec;27(6):652-81. doi: 10.1016/j.pedn.2011.08.001. Epub 2011 Oct 13.

  PMID: 21925588 BACKGROUND

• Gupta D, Agarwal A, Dhiraaj S, Tandon M, Kumar M, Singh RS, Singh PK, Singh U. An evaluation of efficacy of balloon inflation on venous cannulation pain in children: a prospective, randomized, controlled study. Anesth Analg. 2006 May;102(5):1372-5. doi: 10.1213/01.ane.0000205741.82299.d6.

  PMID: 16632812 BACKGROUND

• Usichenko TI, Pavlovic D, Foellner S, Wendt M. Reducing venipuncture pain by a cough trick: a randomized crossover volunteer study. Anesth Analg. 2004 Feb;98(2):343-345. doi: 10.1213/01.ANE.0000094983.16741.AF.

  PMID: 14742367 BACKGROUND

• Wallace DP, Allen KD, Lacroix AE, Pitner SL. The "cough trick:" a brief strategy to manage pediatric pain from immunization injections. Pediatrics. 2010 Feb;125(2):e367-73. doi: 10.1542/peds.2009-0539. Epub 2010 Jan 11.

  PMID: 20064862 BACKGROUND

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 4, 2021
• First Posted: July 30, 2021
• Study Start: August 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: July 30, 2021

Record last verified: 2021-07