Dental AnxietyPLAY-DENTNCT07445594
Effect of Play Dough, Slime, and Plush Toys on Dental Anxiety and Pain in Children During Dental Treatment
A study testing Play Dough Distraction, Slime Distraction and Plush Toy Distraction in people with Dental Anxiety and Dental Pain, run by Afyonkarahisar Health Sciences University.
Trial summary
This study aims to evaluate the effectiveness of tactile distraction materials, including play dough, slime, and plush toys, on dental anxiety, pain perception, and physiological stress responses in children undergoing dental treatment. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Dental Pain, Behavioral Management
- What is being tested?
- Play Dough Distraction, Slime Distraction and Plush Toy Distraction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 17 Feb 2026to 1 Jun 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6-10 years requiring restorative dental treatment.
- Indication for dental treatment under local anesthesia.
- Ability to understand and respond to dental anxiety and pain assessment scales (CFSS-DS and Wong-Baker Faces Scale).
- Children classified as ASA I or ASA II.
- No prior exposure to the distraction materials used in the study during dental treatment.
- Written informed consent obtained from parents or legal guardians.
Who cannot join
- Presence of systemic diseases or medical conditions affecting stress response or contraindicating routine dental treatment
- History of psychiatric, neurological, or developmental disorders that may impair cooperation or communication
- Use of medications influencing anxiety, pain perception, heart rate, or cortisol levels
- Requirement for sedation or general anesthesia for dental treatment
- Acute dental infection or emergency treatment requiring immediate intervention
- Refusal of participation by the child or parent/legal guardian
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
Official title: Evaluation of the Effectiveness of Play Dough, Slime, and Plush Toys on Dental Anxiety, Pain Perception, and Salivary Cortisol Levels in Children During Dental Treatment
This study aims to evaluate the effectiveness of tactile distraction materials, including play dough, slime, and plush toys, on dental anxiety, pain perception, and physiological stress responses in children undergoing dental treatment. Ninety children aged 6-10 years receiving restorative dental treatment under local anesthesia were randomly assigned to one of four groups: play dough, slime, plush toy, or control group without distraction. Dental anxiety and pain levels were assessed using validated psychometric scales, while physiological stress responses were evaluated through heart rate monitoring and salivary cortisol measurements. The study seeks to determine whether simple non-pharmacological distraction techniques can improve behavioral cooperation and reduce anxiety and pain perception during pediatric dental procedures. Findings may contribute to the development of child-friendly dental management strategies and enhance the quality of pediatric dental care.
Read the detailed description
Dental anxiety in children remains a significant challenge in pediatric dentistry, often leading to behavioral management difficulties, delayed treatment, and negative long-term attitudes toward dental care. Non-pharmacological behavioral management strategies, including distraction techniques, are widely recommended to reduce anxiety and improve cooperation during dental procedures. Tactile distraction methods such as play dough, slime, and plush toys may provide sensory engagement that helps shift the child's attention away from dental stimuli; however, comparative evidence regarding their effectiveness remains limited.
This randomized controlled clinical study was designed to evaluate the relative effectiveness of different tactile distraction materials during routine pediatric dental treatment. Children aged 6-10 years requiring restorative dental treatment under local anesthesia were randomly assigned to one of four groups: play dough, slime, plush toy distraction, or a control group without distraction. Standardized clinical procedures were applied to all participants under similar clinical conditions.
Psychological responses were assessed using validated dental anxiety and pain perception scales, while physiological stress responses were monitored using heart rate measurements and salivary cortisol analysis. The study aims to provide evidence on whether simple, low-cost tactile distraction tools can enhance patient comfort, reduce perceived anxiety and pain, and support non-pharmacological behavior management approaches in pediatric dental practice.
- Conditions
- Dental Anxiety, Dental Pain, Behavioral Management
- Being tested
- Play Dough Distraction, Slime Distraction, Plush Toy Distraction, No Distraction (Control)
- Keywords
- Dental Anxiety, Distraction Techniques, Dental Pain, Behavior Management, Salivary Cortisol
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Play Dough DistractionBehavioural
Use of play dough as a tactile distraction during pediatric dental treatment to reduce anxiety and pain perception.
Slime DistractionBehavioural
Use of slime as a tactile distraction during pediatric dental treatment.
Plush Toy DistractionBehavioural
Use of a plush toy as a tactile distraction during pediatric dental treatment.
No Distraction (Control)Behavioural
Standard restorative dental treatment without distraction material.
| Study group | Role | What they receive |
|---|---|---|
| Play Dough Distraction Group | Experimental | Participants used play dough as a tactile distraction during restorative dental treatment under local anesthesia to reduce dental anxiety and pain perception. Receives: Behavioral: Play Dough Distraction; Behavioral: No Distraction (Control) |
| Slime Distraction Group | Experimental | Participants used slime as a tactile distraction during restorative dental treatment under local anesthesia to support anxiety and pain management. Receives: Behavioral: Slime Distraction; Behavioral: No Distraction (Control) |
| Plush Toy Distraction Group | Experimental | Participants held a plush toy as a tactile distraction during restorative dental treatment under local anesthesia. Receives: Behavioral: Plush Toy Distraction; Behavioral: No Distraction (Control) |
| Control Group (No Distraction) | Placebo comparator | Participants received restorative dental treatment under local anesthesia without any distraction material. Receives: Behavioral: No Distraction (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental Anxiety Level Assessed by the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS)
Dental anxiety will be assessed using the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS). The CFSS-DS is a validated 15-item psychometric questionnaire designed to measure dental fear and anxiety in children. Each item is scored on a 5-point Likert scale (1 = not afraid at all to 5 = very afraid), resulting in a total score ranging from 15 to 75.
Higher scores indicate greater dental anxiety (worse outcome).
The scale will be administered immediately before the dental treatment session and immediately after completion of the procedure to evaluate the effect of tactile distraction materials on anxiety levels during restorative dental treatment.
Measured: Immediately before the dental procedure (baseline) and immediately after completion of the dental procedure (same day, periprocedural)
Physiological Stress Response - Cortisol
Physiological stress response will be assessed by measuring salivary cortisol levels as a biomarker of stress. Saliva samples will be collected before and after the dental treatment session using standardized collection procedures, and cortisol levels will be analyzed using an enzyme-linked immunosorbent assay (ELISA) method to evaluate the potential effects of tactile distraction materials on stress responses in pediatric dental patients.
Measured: During the dental procedure (at the 10th minute of treatment)
Secondary outcomes (2)
Pain Perception Assessed by the Wong-Baker FACES Pain Rating Scale
Pain perception will be evaluated using the Wong-Baker FACES® Pain Rating Scale, a validated visual self-report tool commonly used in pediatric populations to measure subjective pain intensity.
The scale consists of six faces corresponding to numerical scores of 0, 2, 4, 6, 8, and 10, resulting in a total score range of 0 to 10, where:
0 = no pain
10 = worst pain possible
Higher scores indicate greater pain intensity (worse outcome).
Pain assessment will be performed immediately after completion of the restorative dental procedure to evaluate the effect of tactile distraction materials on perceived pain.
Measured: Immediately after completion of the dental procedure (same day, periprocedural assessment)
Physiological Stress Response Assessed by Heart Rate Measurement Using Pulse Oximetry
Physiological stress response will be assessed by measuring heart rate using pulse oximetry, a non-invasive method commonly used to monitor physiological stress during dental procedures in pediatric patients.
Heart rate values will be recorded to evaluate physiological responses associated with dental anxiety, pain perception, and the potential effect of tactile distraction materials during restorative dental treatment.
Measured: Baseline (immediately before the dental procedure), during the dental procedure (periprocedural monitoring), and immediately after completion of the dental procedure (same day assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start17 Feb 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental 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 were randomly assigned to one of four parallel groups: play dough, slime, plush toy distraction, or a control group without distraction. Each participant received only one intervention during restorative dental treatment under local anesthesia, and group comparisons were performed to evaluate the effects of tactile distraction on dental anxiety, pain perception, and physiological stress responses.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özgür Doğan, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445594
- Sponsor's protocol ID
- 25.DUS.005
- Acronym
- PLAY-DENT
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to ethical considerations, patient confidentiality, and institutional data protection policies. Only aggregated and anonymized results are reported in scientific publications.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Play Dough, Slime, and Plush Toys on Dental Anxiety, Pain Perception, and Salivary Cortisol Levels in Children During Dental Treatment
- ClinicalTrials.gov ID
- NCT07445594
- Acronym / sponsor ID
- PLAY-DENT / 25.DUS.005
- Conditions
- Dental Anxiety, Dental Pain, Behavioral Management
- Keywords
- Dental Anxiety, Distraction Techniques, Dental Pain, Behavior Management, Salivary Cortisol
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 17 Feb 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 3 Mar 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 study aims to evaluate the effectiveness of tactile distraction materials, including play dough, slime, and plush toys, on dental anxiety, pain perception, and physiological stress responses in children undergoing dental treatment. Ninety children aged 6-10 years receiving restorative dental treatment under local anesthesia were randomly assigned to one of four groups: play dough, slime, plush toy, or control group without distraction. Dental anxiety and pain levels were assessed using validated psychometric scales, while physiological stress responses were evaluated through heart rate monitoring and salivary cortisol measurements. The study seeks to determine whether simple non-pharmacological distraction techniques can improve behavioral cooperation and reduce anxiety and pain perception during pediatric dental procedures. Findings may contribute to the development of child-friendly dental management strategies and enhance the quality of pediatric dental care.
Detailed description
Dental anxiety in children remains a significant challenge in pediatric dentistry, often leading to behavioral management difficulties, delayed treatment, and negative long-term attitudes toward dental care. Non-pharmacological behavioral management strategies, including distraction techniques, are widely recommended to reduce anxiety and improve cooperation during dental procedures. Tactile distraction methods such as play dough, slime, and plush toys may provide sensory engagement that helps shift the child's attention away from dental stimuli; however, comparative evidence regarding their effectiveness remains limited.
This randomized controlled clinical study was designed to evaluate the relative effectiveness of different tactile distraction materials during routine pediatric dental treatment. Children aged 6-10 years requiring restorative dental treatment under local anesthesia were randomly assigned to one of four groups: play dough, slime, plush toy distraction, or a control group without distraction. Standardized clinical procedures were applied to all participants under similar clinical conditions.
Psychological responses were assessed using validated dental anxiety and pain perception scales, while physiological stress responses were monitored using heart rate measurements and salivary cortisol analysis. The study aims to provide evidence on whether simple, low-cost tactile distraction tools can enhance patient comfort, reduce perceived anxiety and pain, and support non-pharmacological behavior management approaches in pediatric dental practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants were randomly assigned to one of four parallel groups: play dough, slime, plush toy distraction, or a control group without distraction. Each participant received only one intervention during restorative dental treatment under local anesthesia, and group comparisons were performed to evaluate the effects of tactile distraction on dental anxiety, pain perception, and physiological stress responses.
| Arm | Type | Receives |
|---|---|---|
| Play Dough Distraction Group | Experimental | Behavioral: Play Dough Distraction, Behavioral: No Distraction (Control)Participants used play dough as a tactile distraction during restorative dental treatment under local anesthesia to reduce dental anxiety and pain perception. |
| Slime Distraction Group | Experimental | Behavioral: Slime Distraction, Behavioral: No Distraction (Control)Participants used slime as a tactile distraction during restorative dental treatment under local anesthesia to support anxiety and pain management. |
| Plush Toy Distraction Group | Experimental | Behavioral: Plush Toy Distraction, Behavioral: No Distraction (Control)Participants held a plush toy as a tactile distraction during restorative dental treatment under local anesthesia. |
| Control Group (No Distraction) | Placebo comparator | Behavioral: No Distraction (Control)Participants received restorative dental treatment under local anesthesia without any distraction material. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged 6-10 years requiring restorative dental treatment.
- Indication for dental treatment under local anesthesia.
- Ability to understand and respond to dental anxiety and pain assessment scales (CFSS-DS and Wong-Baker Faces Scale).
- Children classified as ASA I or ASA II.
- No prior exposure to the distraction materials used in the study during dental treatment.
Key exclusion criteria (6 listed)
- Presence of systemic diseases or medical conditions affecting stress response or contraindicating routine dental treatment
- History of psychiatric, neurological, or developmental disorders that may impair cooperation or communication
- Use of medications influencing anxiety, pain perception, heart rate, or cortisol levels
- Requirement for sedation or general anesthesia for dental treatment
- Acute dental infection or emergency treatment requiring immediate intervention
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 |
|---|---|---|
| Play Dough DistractionUse of play dough as a tactile distraction during pediatric dental treatment to reduce anxiety and pain perception. | Behavioural | Play Dough Distraction Group |
| Slime DistractionUse of slime as a tactile distraction during pediatric dental treatment. | Behavioural | Slime Distraction Group |
| Plush Toy DistractionUse of a plush toy as a tactile distraction during pediatric dental treatment. | Behavioural | Plush Toy Distraction Group |
| No Distraction (Control)Standard restorative dental treatment without distraction material. | Behavioural | Control Group (No Distraction), Play Dough Distraction Group, Plush Toy Distraction Group, Slime Distraction Group |
Primary outcome
Dental Anxiety Level Assessed by the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS)
Time frame: Immediately before the dental procedure (baseline) and immediately after completion of the dental procedure (same day, periprocedural)
Dental anxiety will be assessed using the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS). The CFSS-DS is a validated 15-item psychometric questionnaire designed to measure dental fear and anxiety in children. Each item is scored on a 5-point Likert scale (1 = not afraid at all to 5 = very afraid), resulting in a total score ranging from 15 to 75. Higher scores indicate greater dental anxiety (worse outcome). The scale will be administered immediately before the dental treatment session and immediately after completion of the procedure to evaluate the effect of tactile distraction materials on anxiety levels during restorative dental treatment.
Physiological Stress Response - Cortisol
Time frame: During the dental procedure (at the 10th minute of treatment)
Physiological stress response will be assessed by measuring salivary cortisol levels as a biomarker of stress. Saliva samples will be collected before and after the dental treatment session using standardized collection procedures, and cortisol levels will be analyzed using an enzyme-linked immunosorbent assay (ELISA) method to evaluate the potential effects of tactile distraction materials on stress responses in pediatric dental patients.
2 secondary outcomes
Pain Perception Assessed by the Wong-Baker FACES Pain Rating Scale
Time frame: Immediately after completion of the dental procedure (same day, periprocedural assessment)
Physiological Stress Response Assessed by Heart Rate Measurement Using Pulse Oximetry
Time frame: Baseline (immediately before the dental procedure), during the dental procedure (periprocedural monitoring), and immediately after completion of the dental procedure (same day assessment)
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 3 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to ethical considerations, patient confidentiality, and institutional data protection policies. Only aggregated and anonymized results are reported in scientific publications.
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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 Play Dough Distraction, Slime Distraction and Plush Toy Distraction in people with Dental Anxiety and Dental Pain, run by Afyonkarahisar Health Sciences 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 6 inclusion and 6 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 3 Mar 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. 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?
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 özgür Doğan, Assoc prof. (905052777520, ozgurdogan1984@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental Anxiety Level Assessed by the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) (time frame: Immediately before the dental procedure (baseline) and immediately after completion of the dental procedure (same day, periprocedural)). 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 3 Mar 2026.