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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04113980
Other study ID # Adiyaman University/2018/2-23
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2018
Est. completion date November 1, 2018

Study information

Verified date October 2019
Source Adiyaman University Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)".


Recruitment information / eligibility

Status Completed
Enrollment 134
Est. completion date November 1, 2018
Est. primary completion date November 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 10 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
music group
The children in the groups were distracted by music 2 minutes before venipuncture, until the process was over
kaleidoscope group
The children in the groups were distracted by kaleidoscope 2 minutes before venipuncture, until the process was over
video group
The children in the groups were distracted by watching video 2 minutes before venipuncture, until the process was over

Locations

Country Name City State
Turkey Adiyaman University Adiyaman

Sponsors (1)

Lead Sponsor Collaborator
Adiyaman University Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1 minute
Primary 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'). 1 minute
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