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| Name | Class |
|---|---|
| Ataturk University | OTHER |
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This randomized controlled study aims to evaluate the effect of a drama-based coloring storybook on children's fear, anxiety, and pain management during the perioperative process. The study will be conducted with children aged 6-9 years who are scheduled for elective surgery. Participants will be randomly assigned to either an intervention group receiving the drama-based coloring storybook or a control group receiving routine preoperative care. Levels of fear, anxiety, and pain will be assessed using validated measurement tools at predefined perioperative time points. The findings are expected to contribute to evidence-based, child-centered perioperative care practices.
This study is a randomized controlled trial designed to examine the effectiveness of a drama-based coloring storybook intervention in reducing fear and anxiety and improving pain management in children during the perioperative process. The study population consists of children aged 6-9 years undergoing elective surgical procedures. Participants will be randomly allocated to either an intervention group or a control group.
Children in the intervention group will receive a drama-based coloring storybook titled "Alican's Brave Journey", which introduces the perioperative process through age-appropriate language, illustrations, and interactive coloring activities. The storybook will be administered in the preoperative period by the researcher. The control group will receive routine preoperative care provided by the hospital. Children's fear, anxiety, and pain levels will be measured using validated assessment tools at preoperative and postoperative stages. The study aims to provide evidence on the effectiveness of drama-based educational materials in pediatric perioperative care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drama-Based Coloring Storybook Group | Experimental | Participants in this group receive a drama-based coloring storybook before surgery. The storybook is designed to prepare children for the perioperative process and to reduce fear, anxiety, and perceived pain through age-appropriate narratives and coloring activities. |
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| Control Group (Routine Care) | No Intervention | Participants in this group receive routine preoperative care according to hospital protocols, without exposure to the drama-based coloring storybook. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drama-Based Coloring Storybook Intervention | Behavioral | Children aged 6-9 years in the experimental group receive a drama-based coloring storybook before surgery. The storybook, titled "Alican's Brave Journey," is designed to prepare children for the perioperative process through age-appropriate storytelling, coloring activities, and dramatic elements. The intervention is administered once during the preoperative period under the supervision of the researcher and aims to reduce preoperative fear, anxiety, and perceived pain. |
| Measure | Description | Time Frame |
|---|---|---|
| Preoperative Anxiety Level in Children | Preoperative anxiety will be assessed using the Modified Yale Preoperative Anxiety Scale - Short Form (mYPAS-SF), a validated observational scale consisting of 22 items across five domains: activity, speech, emotional expressivity, state of arousal, and interaction with family members. Total scores range from 23.33 to 100, with higher scores indicating greater anxiety. | One hour before surgery and 10 minutes before surgery (prior to anesthesia induction) |
| Fear Level in Children | Fear levels will be assessed using the Children's Fear Scale (CFS), a validated self-report scale for children. The scale consists of five facial expressions scored from 0 to 4, with higher scores indicating greater fear. | One hour before surgery, 10 minutes before surgery (prior to anesthesia induction), and one hour after surgery |
| Postoperative Pain Level in Children | Postoperative pain will be assessed using the Wong-Baker FACES Pain Rating Scale, a validated self-report pain scale for children. The scale ranges from 0 to 5, where 0 indicates no pain and 5 indicates the worst pain. Higher scores indicate greater pain intensity | One hour after surgery |
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Inclusion Criteria:
Exclusion Criteria:
Only male children aged 6-9 years who are scheduled for circumcision are eligible to participate in the study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yusuf B Budak, PhD Student | Contact | +90 545 961 30 33 | ybudak@bingol.edu.tr |
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Individual participant data will not be shared to protect the privacy and confidentiality of children participating in the study.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 24, 2024 |
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Participants will be randomly assigned to either an intervention group receiving a drama-based coloring storybook or a control group receiving routine preoperative care.
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Participants were blinded to group allocation in order to reduce expectation bias. Due to the nature of the intervention, the care provider and the investigator were aware of the assigned groups. Outcome assessments were conducted using standardized self-report scales completed by the participants.
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| Jan 22, 2026 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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