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CompletedNCT04113980Updated Oct 15, 2019

Effects of Distraction Methods on Pain Perceptions and Anxiety Levels in Children During the Blood Collection

An interventional study of music group and kaleidoscope group in Acute Pain and Nursing Caries, sponsored by Adiyaman University Research Hospital. Completed at 1 site in Turkey. Open to participants aged 5 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-15.

Sponsored by Adiyaman University Research Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Aug 2018, registered Oct 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
134
Allocation
Randomized
Ages
5 Years to 10 Years
Sex
All
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Study summary

Aim:This study was conducted to investigate the effects of music, kaleidoscope and video watching methods on children's pain perception and anxiety level during the blood collection procedures.

Methods: This randomized controlled experimental study was carried out with 134 children in the 5-10 age group in the pediatric blood collection unit of a Training and Research Hospital between August and November 2018. In the study, nonpharmacological methods were applied to the children in the experimental groups (Music Group (n=33), Kaleidoscope Group (n=36), Video Group (n=31). The routine blood collection procedure was used for the children in the control group (n=34). The data were collected using the "Introductory Information Form", "Children's Fear and Anxiety Scale (CFAS)", and the "Wong-Baker Faces Pain Rating Scale (WB-FPRS)".

02

Conditions studied

  • Acute Pain
  • Nursing Caries

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Keywords

  • acute pain
  • anxiety
  • children
  • blood collection
  • nursing
03

In context

Acute Pain

876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.

This study's enrollment of 134 is above the median of 90 across 732 interventional studies indexed under Acute Pain.

Browse Acute Pain studies →

Lead sponsor

Adiyaman University Research Hospital is the lead sponsor of 48 studies on the registry; 9 are open to participants now.

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

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Who can participate

Ages eligible
5 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • being healthy
  • ability to express himself/herself verbally
  • no analgesic taken in the last 6 hours
  • having no visual or auditory problems

Exclusion criteria

Exclusion Criteria:

  • chronic disease
  • mental disease
  • neurological disease
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
134 participants (actual)

Study arms

  • Experimental
    music group

    The children in the groups were distracted by listening music 2 minutes before venipuncture, until the process was over.

    Other: music group

  • Experimental
    kaleidescope group

    The children in the groups were distracted by kaleidoscope 2 minutes before the blood collection, until the process was over.

    Other: kaleidoscope group

  • Experimental
    video group

    The children in the groups were distracted by watching cartoon 2 minutes before the blood collection, until the process was over.

    Other: video group

  • No intervention
    control group

    No intervention was made to children in the control group

Interventions

  • Othermusic group

    The children in the groups were distracted by music 2 minutes before venipuncture, until the process was over

  • Otherkaleidoscope group

    The children in the groups were distracted by kaleidoscope 2 minutes before venipuncture, until the process was over

  • Othervideo group

    The children in the groups were distracted by watching video 2 minutes before venipuncture, until the process was over

06

What researchers measure

Primary outcomes

  1. Children Fear Scale

    The Children Fear Scale was used to evaluate the children's fear and anxiety. Children Fear Scale is a 0-4 scale, showing five faces that range from a neutral expression (0 = no anxiety) to a frightened face (4 = severe anxiety). Preprocedural and procedural pain, and anxiety were evaluated

    Time frame: 1 minute

  2. Wong Baker Face Pain Scale

    The Wong Baker Faces scale is a 0-10 scale. Six faces on the cards show a range of emotions from a smiling face (0 very happy/no pain) to a crying face (10 'hurts worst').

    Time frame: 1 minute

07

Study locations

1 site
  • Adiyaman University
    Adiyaman, 02100, Turkey
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2019, 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
NCT04113980
Lead sponsor
Adiyaman University Research Hospital
Responsible party
Tuba Koc Ozkan (Principal Investigator, Adiyaman University Research Hospital) — Principal investigator
First posted
Oct 3, 2019
Start date
Aug 1, 2018
Primary completion
Nov 1, 2018
Completion
Nov 1, 2018
Last update
Oct 15, 2019

Oversight

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

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This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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