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

NCT ID: NCT06699745

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2025-06-15

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.

Conditions

School Age Children; Endoscopy, Gastrointestinal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

white noise group

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

Group Type: EXPERIMENTAL

white noise intervention

Intervention Type: BEHAVIORAL

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

music group

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

Group Type: EXPERIMENTAL

Music intervention

Intervention Type: 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.

control group

No application was made to the control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

white noise intervention

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Busra Inac Yilmaz

IstanbulUC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Busra Inac Yilmaz, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Locations

Istanbul University-Cerrahpasa

Istanbul, Avcilar, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

IUC-LEE-BIY-26

Identifier Type: -

Identifier Source: org_study_id