Ireland
--:--IST
Enrolling by invitation Not applicable

Comparison of the Effects of Music and White Noise in Children Performed Endoscopy

NCT06699745 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2023-09-15
Last updated
2024-11-21

Condition(s) studied

School Age ChildrenEndoscopy, Gastrointestinal

Investigational drug(s) / intervention(s)

Music interventionwhite noise intervention

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.

white noise intervention: White noise will be played at a decibel level appropriate for the children in the group.

Study summary

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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
12 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Child fear scale — six months
    The Child Fear Scale (CFS), developed by McMurty and colleagues (2011), consists of five drawn facial expressions ranging from a neutral expression (0 = no anxiety) to a frightened face (4 = severe anxiety). The validity and reliability of the scale were performed by Gerçeker and colleagues (2018). The CGI value for the CFS is 0.89 (McMurty et al., 2011).
  • Child anxiety scale-state — six months
    The Child Anxiety Scale State (CAS-S) developed by Ersig et al. (2013) is used to measure the anxiety of the child's current situation. The validity and reliability of the scale were made by Gerceker et al. (2018). The Content Validity Index (CVI) value for CAS-S was found to be 1.00.
  • The Faces Pain Scale - Revised — six months
    It is a self-report measure of pain intensity developed for children. It has been made more suitable for use by using visual depictions of six facial expressions representing increasing levels of pain intensity and by adapting the metric scoring to 0-10. The revised version of the facial pain scale is widely used in the adult and pediatric populations for pain intensity assessment. It is easy to apply and does not require any equipment other than the faces in the picture.

Trial sites (1)

FacilityCityRegionStatus
Istanbul University-Cerrahpasa Istanbul Avcilar
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06699745 on ClinicalTrials.gov ↗ ← All trials in Turkey