Effects of Distraction Methods on Pain Perceptions and Anxiety Levels in Children During the Blood Collection
Primary Purpose
Acute Pain, Nursing Caries
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
music group
kaleidoscope group
video group
Sponsored by
About this trial
This is an interventional prevention trial for Acute Pain focused on measuring acute pain, anxiety, children, blood collection, nursing
Eligibility 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
Sites / Locations
- Adiyaman University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
music group
kaleidescope group
video group
control group
Arm Description
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 kaleidoscope 2 minutes before the blood collection, until the process was over.
The children in the groups were distracted by watching cartoon 2 minutes before the blood collection, until the process was over.
No intervention was made to children in the control group
Outcomes
Primary Outcome Measures
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
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').
Secondary Outcome Measures
Full Information
NCT ID
NCT04113980
First Posted
October 1, 2019
Last Updated
October 12, 2019
Sponsor
Adiyaman University Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04113980
Brief Title
Effects of Distraction Methods on Pain Perceptions and Anxiety Levels in Children During the Blood Collection
Official Title
Effects of Distraction Methods on Pain Perceptions and Anxiety Levels in Children During the Blood Collection
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Adiyaman University Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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)".
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain, Nursing Caries
Keywords
acute pain, anxiety, children, blood collection, nursing
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
music group
Arm Type
Experimental
Arm Description
The children in the groups were distracted by listening music 2 minutes before venipuncture, until the process was over.
Arm Title
kaleidescope group
Arm Type
Experimental
Arm Description
The children in the groups were distracted by kaleidoscope 2 minutes before the blood collection, until the process was over.
Arm Title
video group
Arm Type
Experimental
Arm Description
The children in the groups were distracted by watching cartoon 2 minutes before the blood collection, until the process was over.
Arm Title
control group
Arm Type
No Intervention
Arm Description
No intervention was made to children in the control group
Intervention Type
Other
Intervention Name(s)
music group
Intervention Description
The children in the groups were distracted by music 2 minutes before venipuncture, until the process was over
Intervention Type
Other
Intervention Name(s)
kaleidoscope group
Intervention Description
The children in the groups were distracted by kaleidoscope 2 minutes before venipuncture, until the process was over
Intervention Type
Other
Intervention Name(s)
video group
Intervention Description
The children in the groups were distracted by watching video 2 minutes before venipuncture, until the process was over
Primary Outcome Measure Information:
Title
Children Fear Scale
Description
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
Title
Wong Baker Face Pain Scale
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Adiyaman University
City
Adiyaman
ZIP/Postal Code
02100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Distraction Methods on Pain Perceptions and Anxiety Levels in Children During the Blood Collection
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