- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04113980
Effects of Distraction Methods on Pain Perceptions and Anxiety Levels in Children During the Blood Collection
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)".
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Adiyaman, Turkey, 02100
- Adiyaman University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
1 minute
|
|
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').
|
1 minute
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Adiyaman University/2018/2-23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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