Comparison of the Effects of Music and White Noise in Children Performed Endoscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Music intervention, white noise intervention.
- Who it may be relevant to
- Registry conditions: School Age Children, Endoscopy, Gastrointestinal. Basic parameters: 6 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of the Effects of Music and White Noise on Fear, Anxiety and Pain Levels in Children Performed Endoscopy
Overview
The study was planned as a randomized controlled experimental study to compare the effects of music and white noise on fear, anxiety and pain levels before, during and after the procedure in school-age children (6-12 years old) who will undergo endoscopy. Hypothesis 0 (H0): There is no difference in fear, anxiety, pain, parental anxiety and pulse, respiration and oxygen saturation values between children exposed to music and white noise. Hypothesis 1 (H1): Children who were exposed to music and white noise had lower fear scores than children who were not exposed to any application. Hypothesis 2 (H2): Children who were exposed to music and white noise had lower anxiety scores than children who were not exposed to any application. Hypothesis 3 (H3): Children who were exposed to music and white noise had lower pain scores than children who were not exposed to any application. Hypothesis 4 (H4): Children who were exposed to music and white noise had lower pulse value scores than children who were not exposed to any application. Hypothesis 5 (H5): Children who were exposed to music and white noise had lower respiratory rate scores than children who were not exposed to any application. Hypothesis 6 (H6): Children who were exposed to music and white noise had higher oxygen saturation value scores than children who were not exposed to any application. Hypothesis 7 (H7): Parents of children who were exposed to music and white noise had lower parental anxiety than parents of children who were not exposed to any treatment. There are music group, white noise and control group in the study.
Detailed description
The independent variables of the study are age, gender, music and white noise application.
The dependent variables are; Children's Fear Scale (CFS) scores used to measure children's fear, Children's Anxiety Scale-State (CAS-D) scores used to measure anxiety, The Faces Pain Scale Revised (FPS-R) scores used to measure pain status, pulse, respiratory rate and oxygen saturation values and Beck Anxiety Inventory scores obtained from parents.
Interventions
- Behavioral Music intervention
In studies, white noise was used as a sedative in infants. It was not used in older children. In school-age children, white noise will be used to reduce fear, anxiety and pain during the endoscopy procedure. - Behavioral white noise intervention
White noise will be played at a decibel level appropriate for the children in the group.
Primary outcome measures
- Child fear scale [Time frame: six months]
- Child anxiety scale-state [Time frame: six months]
- The Faces Pain Scale - Revised [Time frame: six months]
Secondary outcome measures (4)
- Beck Anxiety Inventory [Time frame: six months]
- pulse value [Time frame: six months]
- respiratory value [Time frame: six months]
- oxygen saturation value [Time frame: six months]
Eligibility criteria
Inclusion criteria
- School age (6-12 years old) child,
- Have not had an endoscopy procedure before,
- Have not had a surgical procedure before,
- Have been requested to have an endoscopy by a physician,
- Be able to communicate,
- Have no hearing or speech problems,
- Agree to participate in the study,
- Have not used analgesics for 6 hours before the procedure,
- The child can count from 1 to 10,
- Have the ability to order numbers (knowing that numbers are big or small (e.g. 6 is less than 7, 4 is greater than 2, etc.).
Exclusion criteria
- Not being of school age (under 6 years old, over 12 years old),
- Having had an endoscopy procedure before,
- Having had a surgical procedure before,
- Not being able to communicate,
- Having hearing and speech problems,
- Not agreeing to participate in the study,
- Having used analgesics up to 6 hours before the procedure,
- The child not having the ability to sort and count numbers.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Turkey (Türkiye) · 1 center
- Istanbul University-Cerrahpasa — Istanbul
Identifiers
NCT: NCT06699745 · IUC-LEE-BIY-26