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Status unknownNCT04977323Updated Aug 3, 2021

Comparison Effectiveness of Distractions on Pain and Fear of Children

An interventional study of TICK-B group in Peripheral Intravenous Cannulation, sponsored by University of Witten/Herdecke. Status unknown. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2021-08-03.

Sponsored by University of Witten/Herdecke · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
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Study 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.

Read the detailed description

Peripheral intravenous cannulation (PIVC) is an invasive technique. In this technique, a catheter is entrenched through the skin of the recipient into the lumen of a peripheral blood vein. It is the second most painful procedure performed in hospitals. Peripheral intravenous cannulation (PICV) is a common painful procedure for children, and nearly all ill children have experience with PIVC, and up to 80% of patients receive a peripheral venous cannula in a hospital. Therefore, the use of effective methods in pain and anxiety relief is very important during injection procedures in children.

In order to relieve pain and fear in children undergoing PICV. Psychological and physical approaches for coping with children's pain are favored, as well as pharmacological methods. Application of topical anesthetic creams is the most commonly used pharmacological solution to reduce pain associated with the medical procedure, or refrigerant preparations, however, only reduce the perception of pain in children during procedures. These approaches are not resolved anxiety, a core factor of noncooperation, which encumbers the efficiency of the needle procedure. For this cause, non-pharmacological approaches are generally recognized as alternative techniques, which may be used separately or in addition to pharmacological approaches, to provide sufficient pain and fear relief and to offer children a sense of control over the situation.

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Conditions studied

  • Peripheral Intravenous Cannulation
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In context

Lead sponsor

University of Witten/Herdecke is the lead sponsor of 38 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Respiratory chronic diseases,
  2. Physical impairment,
  3. Disability contributing to difficult communication,
  4. Children of unsatisfied parents,
  5. Children with neurodevelopment delay,
  6. Cognitive impairment, hearing impairment or a visual impairment,
  7. Taking an analgesic within 6 hours, or for those with a syncope history.
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    TICK-B group as intervention group

    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

  • Experimental
    Watching cartoons

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

    Other: TICK-B group

  • Experimental
    Group listening to music

    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

  • No intervention
    Standard care provided group as control group

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

Interventions

  • OtherTICK-B group

    These interventions will use as distraction techniques.

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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 5 minutes before procedure done.

  2. 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.

    Time frame: 5 minutes before procedure done

Secondary outcomes

  1. 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.

    Time frame: 0 minute during peripheral cannulation insertion procedure(time during insertion of cannula).

  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.

    Time frame: 1-2 minutes after procedure done.

  3. 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.

    Time frame: 0 minute during cannulation procedure.

  4. 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.

    Time frame: 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.

    Visual Analog Scale (VAS) will be used to measure pain and fear of children by parent and observer.

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

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Hockenberry, M. J., & Wilson, D. (2018). Wong's nursing care of infants and children-E-book. Elsevier Health Sciences.
  • 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. PubMed 23199786 ↗
  • 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. PubMed 25817062 ↗
  • 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. PubMed 22089042 ↗
  • 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. PubMed 14963868 ↗
  • Blount RL, Piira T, Cohen LL, Cheng PS. Pediatric procedural pain. Behav Modif. 2006 Jan;30(1):24-49. doi: 10.1177/0145445505282438. PubMed 16330518 ↗
  • Friedrichsdorf, Stefan J., Donna Eull, and C. A. Weidner.
  • 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. PubMed 26136310 ↗
  • 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. PubMed 18387963 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04977323
Lead sponsor
University of Witten/Herdecke
Responsible party
Sherzad Khudeida Suleman (Principal Investigator (PhD Student), University of Witten/Herdecke) — Principal investigator
First posted
Jul 26, 2021
Start date
Jul 28, 2021 (estimated)
Primary completion
Oct 5, 2021 (estimated)
Completion
Oct 10, 2021 (estimated)
Last update
Aug 3, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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