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

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ClinicalTrials.gov Identifier: NCT04113980
Recruitment Status : Completed
First Posted : October 3, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Tuba Koc Ozkan, Adiyaman University Research Hospital

Brief 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)".


Condition or disease Intervention/treatment Phase
Acute Pain Nursing Caries Other: music group Other: kaleidoscope group Other: video group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Distraction Methods on Pain Perceptions and Anxiety Levels in Children During the Blood Collection
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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

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

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

No Intervention: control group
No intervention was made to children in the control group



Primary Outcome Measures :
  1. Children Fear Scale [ Time Frame: 1 minute ]
    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

  2. Wong Baker Face Pain Scale [ Time Frame: 1 minute ]
    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').



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Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • chronic disease
  • mental disease
  • neurological disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04113980


Locations
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Turkey
Adiyaman University
Adiyaman, Turkey, 02100
Sponsors and Collaborators
Adiyaman University Research Hospital

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Responsible Party: Tuba Koc Ozkan, Principal Investigator, Adiyaman University Research Hospital
ClinicalTrials.gov Identifier: NCT04113980    
Other Study ID Numbers: Adiyaman University/2018/2-23
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tuba Koc Ozkan, Adiyaman University Research Hospital:
acute pain
anxiety
children
blood collection
nursing
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms