Comparison Effectiveness of Distractions on Pain and Fear of Children

NCT04977323 | Unknown

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

Brief Summary

Distraction is a non-pharmacological technique that moves focus away from anxiety, discomfort or unpleasant stimulation to more stimulating or friendly stimulation. Distraction is one of the most effective, simplest and inexpensive non-pharmacological pain management methods (Hockenberry \& Wilson, 2018). The benefits of using non-pharmacological methods include decreased pain, distress, and fear reported by the parent, child, and/or observer (Wente, 2013). There are two main types of distraction techniques: active and passive (Mutlu \& Balcı, 2015; Wohlheiter \& Dahlquist, 2013). Objectives: To evaluate the roles of the TICK-B, listening music, and watching cartoon, in relieving pain and fear of school-age children during PIVC. To compare the effect of TICK-B with the effects of the listening music, and watching cartoon, on reducing pain and fear during PIVC in children. To compare the effects of three distraction groups with the control group in relieving pain and fear during PIVC.

Conditions

Peripheral Intravenous Cannulation

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 Peripheral intravenous cannulation 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.

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

  To assess the fear level of the children related to Peripheral intravenous cannulation 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 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 peripheral cannulation insertion 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 minutes after procedure done.

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

  0 minute during cannulation procedure.

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

  1-2 minute after cannulation procedure done.

Other Outcomes (1)

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

  Immediately after cannualtion (1-2 minutes after procedure to mask observer)

Study Arms (4)

TICK-B group as intervention group

EXPERIMENTAL

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

Other: TICK-B group

Watching cartoons

EXPERIMENTAL

Watching cartoons: In this group, children will watch cartoons as they like. Watching will continue until the procedure is complete.

Other: TICK-B group

Group listening to music

EXPERIMENTAL

Listening to music: In this group, children will listen to cartoon music as they like. Listen will continue until the procedure is complete.

Other: TICK-B group

Standard care provided group as control group

NO INTERVENTION

Control group. The kids in this group will be allowed to keep their family near. The routine blood taking

Interventions

TICK-B group OTHER

These interventions will use as distraction techniques.

Also known as: Watching cartoons, Listening to music group, Control group or no intervention

Group listening to music; TICK-B group as intervention group; Watching cartoons

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 PIVC.

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 (9)

• Hockenberry, M. J., & Wilson, D. (2018). Wong's nursing care of infants and children-E-book. Elsevier Health Sciences.

  BACKGROUND

• Wente SJ. Nonpharmacologic pediatric pain management in emergency departments: a systematic review of the literature. J Emerg Nurs. 2013 Mar;39(2):140-50. doi: 10.1016/j.jen.2012.09.011. Epub 2012 Nov 28.

  PMID: 23199786 BACKGROUND

• Mutlu B, Balci S. Effects of balloon inflation and cough trick methods on easing pain in children during the drawing of venous blood samples: a randomized controlled trial. J Spec Pediatr Nurs. 2015 Jul;20(3):178-86. doi: 10.1111/jspn.12112. Epub 2015 Mar 28.

  PMID: 25817062 BACKGROUND

• Hendry F, Checketts MR, McLeod GA. Effect of intradermal anaesthesia on success rate and pain of intravenous cannulation: a randomized non-blind crossover study. Scott Med J. 2011 Nov;56(4):210-3. doi: 10.1258/smj.2011.011160.

  PMID: 22089042 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

• Blount RL, Piira T, Cohen LL, Cheng PS. Pediatric procedural pain. Behav Modif. 2006 Jan;30(1):24-49. doi: 10.1177/0145445505282438.

  PMID: 16330518 BACKGROUND

• Friedrichsdorf SJ, Eull D, Weidner C, Postier A. A hospital-wide initiative to eliminate or reduce needle pain in children using lean methodology. Pain Rep. 2018 Sep 11;3(Suppl 1):e671. doi: 10.1097/PR9.0000000000000671. eCollection 2018 Sep.

  PMID: 30324169 BACKGROUND

• Shomaker K, Dutton S, Mark M. Pain Prevalence and Treatment Patterns in a US Children's Hospital. Hosp Pediatr. 2015 Jul;5(7):363-70. doi: 10.1542/hpeds.2014-0195.

  PMID: 26136310 BACKGROUND

• Uman LS, Chambers CT, McGrath PJ, Kisely S. A systematic review of randomized controlled trials examining psychological interventions for needle-related procedural pain and distress in children and adolescents: an abbreviated cochrane review. J Pediatr Psychol. 2008 Sep;33(8):842-54. doi: 10.1093/jpepsy/jsn031. Epub 2008 Apr 2.

  PMID: 18387963 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: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (PhD Student)

Study Record Dates

• First Submitted: July 4, 2021
• First Posted: July 26, 2021
• Study Start: July 28, 2021
• Primary Completion: October 5, 2021
• Study Completion: October 10, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-07