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

Istanbul University - Cerrahpasa (IUC)

Status: Invitation-only

Conditions: Endoscopy, Gastrointestinal; School Age Children

Treatments: Behavioral: Music intervention; Behavioral: white noise intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06699745

IUC-LEE-BIY-26

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 3 patient groups

white noise group

Experimental group

Description:

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

Treatment:

Behavioral: white noise intervention

music group

Experimental group

Description:

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

Treatment:

Behavioral: Music intervention

control group

No Intervention group

Description:

No application was made to the control group.