The Effect of Multisensory Stimulation Administered Before Clinical Encounters at the Pediatric Surgery Outpatient Clinic on Children's Anxiety and Fear Levels and Parental Anxiety

The Effect of Multisensory Stimulation Administered Before Clinical Encounters at the Pediatric Surgery Outpatient Clinic on Children's Anxiety and Fear Levels and Parental Anxiety: A Randomized Controlled Study

Encounters with healthcare services during childhood, particularly surgical evaluation processes, are a significant source of stress for both children and their parents. The initial evaluation, physical examination, and the prospect of a possible procedure conducted in pediatric surgery outpatient clinics can lead to increased levels of anxiety and fear in children. This situation not only affects the child's current psychological state but also reduces their cooperation during the examination, makes collaboration with healthcare professionals more difficult, and can negatively impact the overall healthcare experience. Increased levels of anxiety and fear in children are not limited to emotional reactions alone; they also affect physiological and behavioral responses, thereby shaping the entire healthcare process. Similarly, parents may also experience significant situational anxiety due to uncertainty about their child's health status, the possibility of surgical intervention, and the responsibility for care. Parental anxiety is a significant factor that can influence children's levels of anxiety and fear and can indirectly shape the child's healthcare experience through parent-child interaction.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety; Fear; Parental Anxiety; Pediatric Surgery; Randomized Controlled Study; Multisensory Stimulation
• Intervention / Treatment: Other: Multisensory Stimulation

Detailed Description

In recent years, there has been an interest in non-pharmacological interventions to address anxiety and fear levels in pediatric healthcare. Methods such as distraction techniques, digital applications, game solutions, and multisensory stimulation have proven effective in children's health experiences. Multisensory stimulation, particularly with materials containing content targeting the senses of sight, hearing, smell, and touch, is a holistic, non-pharmacological approach that helps reduce developmental stage problems, behavioral issues, pain, fear, and anxiety in children. In its basic mechanism, multisensory stimulation activates tactile, thermal, and emotional systems, providing multiple stimuli and diverting children's attention away from the stressor through simultaneous auditory stimuli. The resulting sensory integration and attention redirection effect can contribute to the improvement of anxiety and fear levels. Among multisensory stimulation applications are: Mother-baby communication, skin-to-skin contact, breastfeeding which activates sensory receptors and taste in the skin, the use of amniotic fluid or aromatic scents are included. In addition, practices such as making eye contact with the baby, speaking in a soft tone of voice, massaging, coordinating and using parental credit are among the components of multisensory stimulation. However, it is noted that this is largely focused on childbirth and that the clinical limits are restricted.

There is limited scientific evidence in the literature that multisensory stimulation may be effective in reducing pain and fear, especially after surgical procedures, in the days of birth. It is observed that the current centers, with multiple voice alerts, are quite limited in addressing the anxiety and fear at home before clinical encounters in pediatric surgery outpatient clinics, where most neonatal or pre-operative processes are evaluated, and the situational anxiety of individuals is addressed together with outbreaks. However, the outpatient setting has critical relationships as the first point of contact with the modern health system, and the anxiety, fear, and parental anxiety experienced at this stage significantly affect the child's subsequent health experiences and compliance with health services. Therefore, the emergence of effective, short-term, and non-pharmacological interventions in the pre-clinical encounter period will be of great importance. In line with this, these randomized controlled trials are planned to examine the effect of multiple sensory stimuli on the situational anxiety of individuals in pediatric surgery outpatient clinics, prior to clinical encounters, and in terms of anxiety and fear. The study results will contribute to supporting a low-level, effective, and effective intervention in pediatric surgery outpatient clinics. Furthermore, it will lay the groundwork for demonstrable practices that will strengthen this developmental, child and family-centered care approach and contribute to the widespread use of psychosocial support practices in pediatric health services.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fulya Merve FMK KOS, Assis Prof Dr; Phone Number: 05300974816; Email: fulya.kos@bilecik.edu.tr

Study Locations

• Turkey (Türkiye)
  • Turkey
    • Bilecik, Turkey, Turkey (Türkiye), 11230
      • Bilecik Şeyh Edebali University
      • Contact: Fulya KOS; Phone Number: 05300974816; Email: fulya.kos@bilecik.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• For the children to be sampled, the inclusion criteria plan to involve children who:
• Are aged between 5 and 10 years,
• Are undergoing their first outpatient pediatric surgery evaluation,
• Have no prior history of surgery, and Agree (along with their parents) to voluntarily participate in the study.

Exclusion Criteria:

• For the children to be sampled, the exclusion criteria plan to omit children who:
• Are in unstable general condition or require emergency medical intervention,
• Have intellectual disabilities, or Have visual or hearing impairments.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The Effect of Multisensory Stimulation on Pain and Anxiety in Children with Pediatric Surgery	Other: Multisensory Stimulation; Multisensory Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children's Pre-procedural Anxiety Level	Children's Anxiety Scale - State Scale The CAS-S resembles a thermometer featuring a bulb at the bottom and horizontal lines spaced at intervals as they rise upwards. Designed for children aged four to ten, this scale instructs children to "Imagine that all your anxious or nervous feelings are in the bulb or lower part of the thermometer." "If you feel a little anxious or tense, your feelings may rise a little higher on the thermometer. "Put a line on the thermometer to show how anxious or nervous you are." It was discovered during the researchers' data collection process that some children were familiar with the typical mercury thermometer represented on the scale, and when children did not understand this analogy, they used an alternative scenario that did not explicitly describe a thermometer. Children are told, "Think of all the anxious or nervous feelings as being at the bottom here (point with your finger on the scale).	(Baseline / Pre-encounter

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children's Fear Level	The Child Fear Scale (CFS), validated and proven reliable by Gerçeker et al. (2018), is used to measure a child's anxiety level. The CFS is a scale that evaluates children's anxiety levels using a 0-4 rating system, consisting of five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety). It can be used by families and researchers to assess pre-procedural and intra-procedural pain and anxiety in children and is aimed at children aged 5-10 years. The CFS is based on the Faces Anxiety Scale developed by McKinley et al. (2003) to measure the fear or anxiety of adults in the intensive care unit. It is a scale consisting of one item and five gender-neutral faces. The facial muscle changes in the fearful expressions were drawn by a graphic artist based on photographs of frightened faces. The scale will be administered to children as a pre-test and post-test.	Baseline / Pre-encounter

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental State Anxiety Level	State-Trait Anxiety Inventory A 10-item short version of the 40-item State-Trait Anxiety Inventory (STAI) was developed by Zsido et al. In the process of shortening the STAI, Zsido et al. (2020) first removed the reverse-scored items from the scale and then reduced these inventories to their short 5-item forms (STAIS-5 and STAIT-5) by performing confirmatory factor analysis (CFA), item response theory analysis, and ROC analysis to preserve the best discriminating items. The 4-point Likert-type scales consist of 5 items. The emotions and behaviors indicated in STAIS-5 are marked according to their degree of severity as 1 = None, 2 = Somewhat, 3 = Moderately, 4 = Very much; and the STAIT-5 items are marked as 1 = None, 2 = Sometimes, 3 = Moderately, 4 = Very much. Individuals scoring 10 or higher on STAIS-5 and 14 or higher on STAIT-5 are considered clinically anxious. The Cronbach's alpha values for STAIS-5 and STAIT-5 were calculated as 0.86 and 0.91.	Baseline / Pre-encounter

Collaborators and Investigators

• Sponsor: Bilecik Seyh Edebali Universitesi

Publications and helpful links

General Publications

• No publications resulting from this study are available at this time as the trial is currently ongoing.

Study record dates

Study Major Dates

• Study Start (Estimated): July 29, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: August 10, 2026
• First Submitted That Met QC Criteria: August 12, 2026
• First Posted (Actual): August 18, 2026

Study Record Updates

• Last Update Posted (Actual): August 19, 2026
• Last Update Submitted That Met QC Criteria: August 17, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: anxiety; pediatric surgery; fear; multisensory stimulation; parental anxiety
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: Bilecik-BSEU3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Individual Participant Data (IPD) will not be made publicly available or shared for this study due to ethical considerations regarding participant confidentiality and the explicit terms of the informed consent protocol.

Specifically:

Informed Consent Constraints: The informed consent forms approved by the Institutional Review Board (IRB) / Ethics Committee and signed by the parents/guardians do not include permissions for raw, individual-level data sharing with external third parties or public repositories.

Privacy and Vulnerability: Given that the study population consists of pediatric patients undergoing clinical evaluations, raw IPD contains sensitive demographic and clinical details that could potentially compromise participant anonymity.

De-identified aggregate statistical data, protocol details, and final study findings will be made available through published peer-reviewed journal articles and clinical trial registries upon study completion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No