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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| white noise group | Experimental | Children in the group will be made to listen to white noise at an appropriate decibel level. |
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| music group | Experimental | Music will be listened at an appropriate decibel level for the children in the group. |
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| control group | No Intervention | No application was made to the control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Anxiety Inventory | Developed by Beck et al. (1988). The Cronbach alpha coefficient of the original scale is .93. The Turkish adaptation of the Beck Anxiety Inventory was prepared by Ulusoy et al. (1998). In the Turkish validity and reliability study of the scale, Cronbach alpha coefficient was determined as .93. The Beck Anxiety Inventory is a 21-question scale that individuals can answer on their own. Questions are scored between 0 and 3. The minimum score is 0 and the maximum score is 63. The total score is used in the evaluation of the scale. Increasing scores on the scale indicate an increase in the anxiety level. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Busra Inac Yilmaz, MD | Istanbul University - Cerrahpasa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University-Cerrahpasa | Istanbul | Avcilar | 34320 | Turkey (Türkiye) |
I think it is not appropriate to share all information in terms of patient privacy.
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| white noise intervention | Behavioral | White noise will be played at a decibel level appropriate for the children in the group. |
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| six months |
| pulse value | In the study, the child's pulse value was measured from the calibrated monitor before, during and after the endoscopy procedure. | six months |
| respiratory value | In the study, the child's respiratory value was measured from the calibrated monitor before, during and after the endoscopy procedure. | six months |
| oxygen saturation value | In the study, the child's respiratory value was measured from the calibrated monitor before, during and after the endoscopy procedure. | six months |