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NCT Number: NCT07445594

Effect of Play Dough, Slime, and Plush Toys on Dental Anxiety and Pain 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.

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Key information

Conditions

Dental Anxiety Behavioral Management Dental Pain Facial Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Tooth Diseases Toothache

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Play Dough Distraction

Behavioral

Use of play dough as a tactile distraction during pediatric dental treatment to reduce anxiety and pain perception.

Slime Distraction

Behavioral

Use of slime as a tactile distraction during pediatric dental treatment.

Plush Toy Distraction

Behavioral

Use of a plush toy as a tactile distraction during pediatric dental treatment.

No Distraction (Control)

Behavioral

Standard restorative dental treatment without distraction material.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Pain Perception Assessed by the Wong-Baker FACES Pain Rating Scale

    Time frame: Immediately after completion of the dental procedure (same day, periprocedural assessment)

    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.

  2. 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)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nilay Yılmaz, Research Asisstant

CONTACT

[email protected]

+90 537 708 51 37

özgür Doğan, Assoc prof.

CONTACT

[email protected]

905052777520

Sponsors and collaborators

Lead sponsor

Afyonkarahisar Health Sciences University

Other

Registry information

Official study 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

Acronym: PLAY-DENT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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