Clinical trial NCT06699745: Comparison of the Effects of Music and White Noise in Children Performed Endoscopy
Official title: Comparison of the Effects of Music and White Noise on Fear, Anxiety and Pain Levels in Children Performed Endoscopy
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: School Age Children
Endoscopy, Gastrointestinal
Keywords: endoscopy
fear
anxiety
pain
music
white noise
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 102
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

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.

Primary outcomes:
measure: Child fear scale
timeFrame: six months
measure: Child anxiety scale-state
timeFrame: six months
measure: The Faces Pain Scale - Revised
timeFrame: six months
Secondary outcomes:
measure: Beck Anxiety Inventory
timeFrame: six months
measure: pulse value
timeFrame: six months
measure: respiratory value
timeFrame: six months
measure: oxygen saturation value
timeFrame: six months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
state: Avcilar
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Busra Inac Yilmaz, MD
role: PRINCIPAL_INVESTIGATOR
References: