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

NCT06699745 | Enrolling By Invitation

• 1 other identifier: IUC-LEE-BIY-26
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

School Age Children; Endoscopy, Gastrointestinal

Keywords

endoscopy; fear; anxiety; pain; music; white noise

Outcome Measures

Primary Outcomes (3)

• Child fear scale

  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).

  six months

• Child anxiety scale-state

  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.

  six months

• The Faces Pain Scale - Revised

  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.

  six months

Secondary Outcomes (4)

• Beck Anxiety Inventory

  six months

• pulse value

  six months

• respiratory value

  six months

• oxygen saturation value

  six months

Study Arms (3)

white noise group

EXPERIMENTAL

Children in the group will be made to listen to white noise at an appropriate decibel level.

Behavioral: white noise intervention

music group

EXPERIMENTAL

Music will be listened at an appropriate decibel level for the children in the group.

Behavioral: Music intervention

control group

NO INTERVENTION

No application was made to the control group.

Interventions

Music intervention BEHAVIORAL

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.

music group

white noise intervention BEHAVIORAL

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

white noise group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Avcilar, 34320, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Busra Inac Yilmaz, MD

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: IstanbulUC

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 21, 2024
• Study Start: September 15, 2023
• Primary Completion: September 15, 2024
• Study Completion: June 15, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)