Preoperative AnxietyNCT07414628
The Effect of a Drama-Based Coloring Storybook on Children's Fear, Anxiety, and Pain Management in the Perioperative Process: "Alican's Brave Journey"
A study testing Drama-Based Coloring Storybook Intervention in people with Preoperative Anxiety and PAİN, run by Bingol University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 9 years, men only
- Conditions the study is for
- Preoperative Anxiety, PAİN, Fear
- What is being tested?
- Drama-Based Coloring Storybook Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6-9 years.
- Children scheduled for surgery due to circumcision.
- Children who have not undergone previous surgery.
- Children without vision, hearing, or speech problems.
Who cannot join
- Children who have undergone previous surgery.
- Children with vision, hearing, or speech problems.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Conditions
- Preoperative Anxiety, PAİN, Fear
- Being tested
- Drama-Based Coloring Storybook Intervention
- Keywords
- Drama, Storybook, Pediatric, Pain, Anxiety
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drama-Based Coloring Storybook InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Drama-Based Coloring Storybook Intervention |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: One hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either an intervention group receiving a drama-based coloring storybook or a control group receiving routine preoperative care.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bingol University
- Sponsor type
- University, hospital or other
- Collaborators
- Ataturk University
- Responsible party
- Principal investigator, Yusuf Budak, Bingol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414628
- Sponsor's protocol ID
- E-33117789-044-163219
- Status last verified
- Feb 2026
- First submitted
- 22 Jan 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect the privacy and confidentiality of children participating in the study.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Drama-Based Coloring Storybook on Children's Fear, Anxiety, and Pain Management in the Perioperative Process: "Alican's Brave Journey"
- ClinicalTrials.gov ID
- NCT07414628
- Acronym / sponsor ID
- E-33117789-044-163219
- Conditions
- Preoperative Anxiety, PAİN, Fear
- Keywords
- Drama, Storybook, Pediatric, Pain, Anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Bingol UniversityUniversity, hospital or other
- Collaborators
- Ataturk University
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either an intervention group receiving a drama-based coloring storybook or a control group receiving routine preoperative care.
| Arm | Type | Receives |
|---|---|---|
| Drama-Based Coloring Storybook Group | Experimental | Behavioral: Drama-Based Coloring Storybook InterventionParticipants 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. |
| 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. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 6-9 years.
- Children scheduled for surgery due to circumcision.
- Children who have not undergone previous surgery.
- Children without vision, hearing, or speech problems.
Key exclusion criteria (2 listed)
- Children who have undergone previous surgery.
- Children with vision, hearing, or speech problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drama-Based Coloring Storybook InterventionChildren 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. | Behavioural | Drama-Based Coloring Storybook Group |
Primary outcome
Preoperative Anxiety Level in Children
Time frame: One hour before surgery and 10 minutes before surgery (prior to anesthesia induction)
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.
Fear Level in Children
Time frame: One hour before surgery, 10 minutes before surgery (prior to anesthesia induction), and one hour after surgery
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.
Postoperative Pain Level in Children
Time frame: One hour after surgery
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect the privacy and confidentiality of children participating in the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Drama-Based Coloring Storybook Intervention in people with Preoperative Anxiety and PAİN, run by Bingol University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yusuf B Budak, PhD Student (+90 545 961 30 33, ybudak@bingol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative Anxiety Level in Children (time frame: One hour before surgery and 10 minutes before surgery (prior to anesthesia induction)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.