NCT07151131

Brief Summary

Preoperative anxiety arises as a physiological response of the body to stressors and is pathophysiologically associated with stimulation of the autonomic nervous system and increased catecholamine release (Durgut, 2021). As a result, elevated levels of cortisol and epinephrine in the body can cause cytotoxic effects at the cellular level. This physiological mechanism may lead to hypertension, arrhythmia, tachycardia, and tachypnea in children (Dehghan et al., 2019; Durgut, 2021). Due to these effects, recent evidence-based studies have focused on the use of non-pharmacological approaches with fewer side effects to manage anxiety in children (Kavak et al., 2019). According to the literature, various techniques have been identified as effective interventions for reducing preoperative anxiety in children, including: Listening to music, Playing games, Using dramatic puppets, Interactive play, Virtual reality applications, Watching cartoons, Playing favorite video games, Video presentations, Hospital clowns, Storybooks, Visual and auditory stimuli

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

Same day

First QC Date

July 18, 2025

Last Update Submit

September 2, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Anxiety Tool: Preoperative Anxiety Scale

    Baseline, Postoperative 60th and 120th minutes

  • Pain Tool: Wong-Baker FACES Pain Rating Scale

    Postoperative 60th and 120th minutes

  • Nausea Tool: standardized observational nausea scale

    Postoperative 60th and 120th minutes

Study Arms (2)

intervention group

EXPERIMENTAL

Watching Cartoons and Reflexology Massage

Other: Watching CartoonsOther: Reflexology

Control Group

NO INTERVENTION

Control Group

Interventions

Cartoon Group Intervention Children assigned to the cartoon group will be taken from the clinic to the preoperative room. Approximately 30 minutes before being transferred to the operating room, children will be allowed to watch a cartoon of their choice on a 60-inch screen TV placed approximately 200 cm away. The duration of the cartoon viewing session will be limited to 20 minutes. The measurement tools used in the study will be administered at five different time points: Immediately before watching the cartoon, Immediately after watching the cartoon but before being transferred to the operating room, In the postoperative period at the 60th minute, At the 120th minute postoperatively, And finally, at the discharge phase.

intervention group

Massage Group Intervention Children assigned to the massage group will be transferred from the clinic to the preoperative room. Approximately 30 minutes before being taken to the operating room, reflexology massage will be applied by the researcher physician Xxx XXXXX, who holds a valid reflexology certification. The massage will be administered to both the right and left feet, with 10 minutes per foot, for a total duration of 20 minutes. The measurement tools used in the study will be applied at five distinct time points: Before the massage, Immediately after the massage but before operating room transfer, In the postoperative period at the 60th minute, At the 120th minute postoperatively, And finally, during the discharge phase.

intervention group

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Participants were included in the study if they met all of the following conditions:
  • The child was hospitalized in the pediatric surgical clinic for a planned (elective) surgery,
  • The child was aged between 4 and 6 years,
  • The child was scheduled to receive general anesthesia,
  • Neither the child nor the primary caregiver had any visual, hearing, or cognitive impairments,
  • The child had no anatomical abnormalities or tissue integrity issues in the feet,
  • Verbal assent was obtained from the child,
  • Both parents provided written and verbal informed consent for participation,
  • Both the child and parents were willing and voluntarily agreed to participate in the study.

You may not qualify if:

  • Participants were excluded from the study if any of the following conditions occurred:
  • Postoperative bleeding tendency developed in the child,
  • The child required postoperative intensive care,
  • A high-risk complication developed after surgery,
  • The child failed to initiate spontaneous respiration postoperatively,
  • Intraoperative death (exitus) occurred,
  • The child experienced prolonged unconsciousness due to anesthesia,
  • The child underwent surgical procedures involving the feet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AgnosiaPostoperative Nausea and Vomiting

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesNauseaSigns and Symptoms, DigestiveVomiting

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Central Study Contacts

Öznur Tiryaki, Asoss.Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 18, 2025

First Posted

September 3, 2025

Study Start

September 1, 2025

Primary Completion

September 1, 2025

Study Completion

December 1, 2025

Last Updated

September 3, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Ethically, patient information can be shared upon reasonable request without revealing their identities for security reasons.