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Not yet recruiting NCT07151131

Cartoons and Reflexology for Postoperative Nausea, Pain, and Anxiety in Children

No phase Interventional Children Pain Management Nausea, Postoperative

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Watching Cartoons, Reflexology.
Who it may be relevant to
Registry conditions: Children, Pain Management, Nausea, Postoperative. Basic parameters: 4 years — 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

  • Other Watching Cartoons
    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
  • Other Reflexology
    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

Primary outcome measures

  • Anxiety Tool: Preoperative Anxiety Scale [Time frame: Baseline, Postoperative 60th and 120th minutes]
  • Pain Tool: Wong-Baker FACES Pain Rating Scale [Time frame: Postoperative 60th and 120th minutes]
  • Nausea Tool: standardized observational nausea scale [Time frame: Postoperative 60th and 120th minutes]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07151131 · Hava Tetik Özel

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗