Trials / Enrolling By Invitation
Enrolling By InvitationNCT06699745
Comparison of the Effects of Music and White Noise in Children Performed Endoscopy
Comparison of the Effects of Music and White Noise on Fear, Anxiety and Pain Levels in Children Performed Endoscopy
- Status
- Enrolling By Invitation
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 102 (estimated)
- Sponsor
- Istanbul University - Cerrahpasa · Academic / Other
- Sex
- All
- Age
- 6 Years – 12 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | 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. |
| BEHAVIORAL | white noise intervention | White noise will be played at a decibel level appropriate for the children in the group. |
Timeline
- Start date
- 2023-09-15
- Primary completion
- 2024-09-15
- Completion
- 2025-06-15
- First posted
- 2024-11-21
- Last updated
- 2024-11-21
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT06699745. Inclusion in this directory is not an endorsement.