Preoperative FearNCT07430995
Comparing Storybooks and Hand Puppets to Reduce Fear in Children Undergoing Day Surgery
A study testing Storybook Group and Hand Puppet Group in people with Preoperative Fear and Emotional Distress, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
Trial summary
Summary The aim of this study is to see if storybooks or hand puppets help reduce fear in children before outpatient surgery. Researchers want to find out which of these two methods works better to help children feel calmer and less upset. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Preoperative Fear, Emotional Distress
- What is being tested?
- Storybook Group and Hand Puppet Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 25 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged between 4 and 7 years.
- Children hospitalized in the pediatric surgery ward.
- Scheduled for elective (planned) surgery.
- Ability to understand and speak Turkish.
- Willingness of both the child and a parent/legal guardian to participate in the study.
Who cannot join
- Children with long-term hospitalization history.
- Participants who received analgesic or sedative medication within the last 24 hours.
- Presence of major trauma, chronic disease, or chronic pain conditions requiring rapid assessment.
- Any physical or cognitive impairment that hinders effective communication (e.g., significant visual, hearing, or speech impairments).
- Presence of diagnosed mental or developmental disabilities.
- History of psychiatric disorders such as Attention Deficit Hyperactivity Disorder (ADHD).
- Participants or parents who wish to withdraw from the study at any stage.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mus State Hospital, Pediatric Surgery Department
Muş, Province, 49000
About this study
Official title: The Effect of Two Different Distraction Methods Applied Before Day Case Surgery on Children's Fear and Emotional Indicators: A Randomized Controlled Trial
Summary The aim of this study is to see if storybooks or hand puppets help reduce fear in children before outpatient surgery. Researchers want to find out which of these two methods works better to help children feel calmer and less upset.
Why is this study being conducted? Going into surgery can be frightening for children. This research is looking for simple and fun ways to reduce a child's fear without using medication.
Read more
How will the research be conducted?
The study included 99 children (ages 4-7) undergoing outpatient surgery. The children were divided into three equal groups:
Group 1 (Control): Received standard hospital care.
Group 2 (Storybook): Read an educational book about a character going into surgery.
Group 3 (Puppet): Played with a hand puppet before the procedure.
Researchers measured the children's fear and emotional responses twice: approximately 1 hour before surgery and immediately before entering the operating room. By comparing these scores, the study shows whether it was the storybook or the puppet that helped the children feel better.
Read the detailed description
The aim of this randomized controlled trial is to evaluate and compare the effectiveness of two different non-pharmacological distraction methods-educational storybooks and hand puppets-on preoperative fear and emotional manifestations in children undergoing day case surgery.
Methodology:
The study was conducted with 99 children, aged 4 to 7, who met the inclusion criteria. Participants were randomly assigned to one of three groups using a 1:1:1 allocation ratio:
Control Group (n=33): Received standard preoperative nursing care, including routine information provided by the hospital staff.
Storybook Group (n=33): In addition to standard care, children were read an educational storybook titled "Elif Ameliyat Oluyor" (Elif is Having Surgery). The book describes the surgical process through a child's perspective to familiarize them with the environment.
Hand Puppet Group (n=33): In addition to standard care, a researcher engaged the child in interactive play using a hand puppet. The puppet was used to simulate the medical procedures in a non-threatening and playful manner.
Data Collection and Outcome Measures:
Two primary tools were used to collect data:
Child Fear Scale (CFS): A self-report scale used to assess the child's level of fear.
Children's Emotional Manifestation Scale (CEMS): An observational scale used by researchers to record behaviors such as crying, facial expressions, and cooperation.
Data were collected at two specific time points:
T1 (Baseline): Approximately 1 hour before the surgical procedure (pre-intervention).
T2 (Final): Immediately before the child was transferred to the operating room (post-intervention).
The study seeks to determine whether these distraction techniques significantly lower fear scores compared to standard care and which method is more effective in a clinical setting.
- Conditions
- Preoperative Fear, Emotional Distress
- Being tested
- Storybook Group, Hand Puppet Group, Control Group
- Keywords
- Pediatric Surgery, Preoperative Fear, Distraction Techniques, Storytelling, Puppetry, Emotional Responses, Nursing Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Storybook GroupBehavioural
Participants completed an information form immediately after being admitted to the clinic in the morning. Then, a researcher read an educational storybook titled "Elif is Having Surgery." The intervention aimed to focus the child's attention on the surgical process through storytelling. Following this, a form was administered to measure fear and emotional indicators. One hour later, before the patient donned the surgical gown and left the room for surgery, the same story was read to the group again.
Hand Puppet GroupBehavioural
Participants completed an introductory information form immediately after being admitted to the clinic in the morning. Then, a researcher used gender-specific felt hand puppets to help children integrate into the hospital environment, facilitate their adaptation to preoperative preparation, and reduce preoperative fear and negative emotional indicators. A form to measure fear and emotional indicators was then administered. One hour later, before the patient donned their surgical gown and left the room for surgery, the same puppet procedure was repeated for this group.
Control GroupOther
Participants completed an introductory information form immediately after being admitted to the clinic in the morning. Then, clinic nurses provided information about the routine procedure to prepare them for the operation. Following this, a form was administered to measure fear and emotional indicators. One hour later, before the patient donned the surgical gown and left the room for surgery, the same procedure was repeated to this group.
| Study group | Role | What they receive |
|---|---|---|
| Storybook Group | Experimental | Prior to the intervention, participants were read an educational storybook titled "Elif is Having Surgery" by a researcher. The intervention focused on introducing the child to the surgical process through storytelling. Receives: Behavioral: Storybook Group |
| Hand Puppet Group | Experimental | Participants engaged in pre-intervention interactive play with a hand puppet under the guidance of a researcher. The puppet recorded the treatment process to simulate the treatment and provide emotional support through play. Receives: Behavioral: Hand Puppet Group |
| Control Group | Placebo comparator | Participants in this group received only the standard preoperative nursing care provided by the hospital, with no additional distraction methods. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Fear Scale (CFS) Score
The CFS is a self-report scale consisting of five faces ranging from a neutral expression (0 - no fear) to a frightened expression (4 - extreme fear). It is used to measure the child's subjective level of fear.
Measured: "Baseline (immediately upon hospital admission, approximately 1 hour before surgery) and pre-operative phase (approximately 60 minutes after the first measurement, just before transfer to the operating room)."
Children's Emotional Manifestation Scale (CEMS) Score
An observational scale consisting of 5 categories (facial expression, vocalization, activity, interaction, and cooperation). Each category is scored from 1 to 5, with total scores ranging from 5 to 25. Higher scores indicate higher emotional distress.
Measured: Baseline (immediately upon hospital admission, approximately 1 hour before surgery) and pre-operative phase (approximately 60 minutes after the first measurement, just before transfer to the operating room).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Jan 2025
- Primary completion20 Jun 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative FearStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muş Alparslan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Beyaz, Muş Alparslan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430995
- Sponsor's protocol ID
- 13.11.2024-167632
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will be shared in de-identified form upon reasonable request to the Principal Investigator. Data will be available after publication of the main results and will be provided only for research purposes with appropriate ethical approval.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Distraction Methods Applied Before Day Case Surgery on Children's Fear and Emotional Indicators: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07430995
- Acronym / sponsor ID
- 13.11.2024-167632
- Conditions
- Preoperative Fear, Emotional Distress
- Keywords
- Pediatric Surgery, Preoperative Fear, Distraction Techniques, Storytelling, Puppetry, Emotional Responses, Nursing Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Muş Alparslan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 24 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.
Summary The aim of this study is to see if storybooks or hand puppets help reduce fear in children before outpatient surgery. Researchers want to find out which of these two methods works better to help children feel calmer and less upset.
Why is this study being conducted? Going into surgery can be frightening for children. This research is looking for simple and fun ways to reduce a child's fear without using medication.
How will the research be conducted?
The study included 99 children (ages 4-7) undergoing outpatient surgery. The children were divided into three equal groups:
Group 1 (Control): Received standard hospital care.
Group 2 (Storybook): Read an educational book about a character going into surgery.
Group 3 (Puppet): Played with a hand puppet before the procedure.
Researchers measured the children's fear and emotional responses twice: approximately 1 hour before surgery and immediately before entering the operating room. By comparing these scores, the study shows whether it was the storybook or the puppet that helped the children feel better.
Detailed description
The aim of this randomized controlled trial is to evaluate and compare the effectiveness of two different non-pharmacological distraction methods-educational storybooks and hand puppets-on preoperative fear and emotional manifestations in children undergoing day case surgery.
Methodology:
The study was conducted with 99 children, aged 4 to 7, who met the inclusion criteria. Participants were randomly assigned to one of three groups using a 1:1:1 allocation ratio:
Control Group (n=33): Received standard preoperative nursing care, including routine information provided by the hospital staff.
Storybook Group (n=33): In addition to standard care, children were read an educational storybook titled "Elif Ameliyat Oluyor" (Elif is Having Surgery). The book describes the surgical process through a child's perspective to familiarize them with the environment.
Hand Puppet Group (n=33): In addition to standard care, a researcher engaged the child in interactive play using a hand puppet. The puppet was used to simulate the medical procedures in a non-threatening and playful manner.
Data Collection and Outcome Measures:
Two primary tools were used to collect data:
Child Fear Scale (CFS): A self-report scale used to assess the child's level of fear.
Children's Emotional Manifestation Scale (CEMS): An observational scale used by researchers to record behaviors such as crying, facial expressions, and cooperation.
Data were collected at two specific time points:
T1 (Baseline): Approximately 1 hour before the surgical procedure (pre-intervention).
T2 (Final): Immediately before the child was transferred to the operating room (post-intervention).
The study seeks to determine whether these distraction techniques significantly lower fear scores compared to standard care and which method is more effective in a clinical setting.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Storybook Group | Experimental | Behavioral: Storybook GroupPrior to the intervention, participants were read an educational storybook titled "Elif is Having Surgery" by a researcher. The intervention focused on introducing the child to the surgical process through storytelling. |
| Hand Puppet Group | Experimental | Behavioral: Hand Puppet GroupParticipants engaged in pre-intervention interactive play with a hand puppet under the guidance of a researcher. The puppet recorded the treatment process to simulate the treatment and provide emotional support through play. |
| Control Group | Placebo comparator | Other: Control GroupParticipants in this group received only the standard preoperative nursing care provided by the hospital, with no additional distraction methods. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged between 4 and 7 years.
- Children hospitalized in the pediatric surgery ward.
- Scheduled for elective (planned) surgery.
- Ability to understand and speak Turkish.
- Willingness of both the child and a parent/legal guardian to participate in the study.
Key exclusion criteria (7 listed)
- Children with long-term hospitalization history.
- Participants who received analgesic or sedative medication within the last 24 hours.
- Presence of major trauma, chronic disease, or chronic pain conditions requiring rapid assessment.
- Any physical or cognitive impairment that hinders effective communication (e.g., significant visual, hearing, or speech impairments).
- Presence of diagnosed mental or developmental disabilities.
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 |
|---|---|---|
| Storybook GroupParticipants completed an information form immediately after being admitted to the clinic in the morning. Then, a researcher read an educational storybook titled "Elif is Having Surgery." The intervention aimed to focus the child's attention on the surgical process through storytelling. Following this, a form was administered to measure fear and emotional indicators. One hour later, before the patient donned the surgical gown and left the room for surgery, the same story was read to the group again. | Behavioural | Storybook Group |
| Hand Puppet GroupParticipants completed an introductory information form immediately after being admitted to the clinic in the morning. Then, a researcher used gender-specific felt hand puppets to help children integrate into the hospital environment, facilitate their adaptation to preoperative preparation, and reduce preoperative fear and negative emotional indicators. A form to measure fear and emotional indicators was then administered. One hour later, before the patient donned their surgical gown and left the room for surgery, the same puppet procedure was repeated for this group. | Behavioural | Hand Puppet Group |
| Control GroupParticipants completed an introductory information form immediately after being admitted to the clinic in the morning. Then, clinic nurses provided information about the routine procedure to prepare them for the operation. Following this, a form was administered to measure fear and emotional indicators. One hour later, before the patient donned the surgical gown and left the room for surgery, the same procedure was repeated to this group. | Other | Control Group |
Primary outcome
Child Fear Scale (CFS) Score
Time frame: "Baseline (immediately upon hospital admission, approximately 1 hour before surgery) and pre-operative phase (approximately 60 minutes after the first measurement, just before transfer to the operating room)."
The CFS is a self-report scale consisting of five faces ranging from a neutral expression (0 - no fear) to a frightened expression (4 - extreme fear). It is used to measure the child's subjective level of fear.
Children's Emotional Manifestation Scale (CEMS) Score
Time frame: Baseline (immediately upon hospital admission, approximately 1 hour before surgery) and pre-operative phase (approximately 60 minutes after the first measurement, just before transfer to the operating room).
An observational scale consisting of 5 categories (facial expression, vocalization, activity, interaction, and cooperation). Each category is scored from 1 to 5, with total scores ranging from 5 to 25. Higher scores indicate higher emotional distress.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be shared in de-identified form upon reasonable request to the Principal Investigator. Data will be available after publication of the main results and will be provided only for research purposes with appropriate ethical approval.
Related trials for Preoperative Fear
Recruiting
Virtual Reality for Pediatric Perioperative Preparation
Preoperative Anxiety, Fear
Not yet recruiting
Bookbased Emotion and Anxiety Reduction
Pediatric Anesthesia, Pediatric Surgery
Not yet recruiting
Effects of Different Transport Methods on Preoperative Anxiety and Fear in Preschool Children
Preoperative Anxiety, Preoperative Fear
Not yet recruiting
The Effect of Mandala Art Therapy on Surgical Fear and the Stress Hormone (Cortisol) in High-risk Pregnant Women Before Cesarean Section.
High-risk Nulliparous Pregnancy, Patients Scheduled for Cesarean Section, Surgical Fear, Preoperative Anxiety, and Cortisol Level
Recruiting
The Effect of Progressive Relaxation Exercises With Therapeutic Clown
Therapeutic Clown, Relaxation Exercise
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Storybook Group and Hand Puppet Group in people with Preoperative Fear and Emotional Distress, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Fear Scale (CFS) Score (time frame: "Baseline (immediately upon hospital admission, approximately 1 hour before surgery) and pre-operative phase (approximately 60 minutes after the first measurement, just before transfer to the operating room)."). The study lists 2 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 24 Feb 2026.