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

NCT ID: NCT07151131

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2025-12-01

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

Conditions

Children; Pain Management; Nausea, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

intervention group

Watching Cartoons and Reflexology Massage

Group Type: EXPERIMENTAL

Watching Cartoons

Intervention Type: OTHER

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.

Reflexology

Intervention Type: OTHER

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.

Control Group

Control Group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 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 Type: 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 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 Type: OTHER

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sakarya University

OTHER

Sponsor Role: lead

Responsible Party

öznur tiryaki

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Öznur Tiryaki, Asoss.Prof.

Role: CONTACT

oznuritiryaki@gmail.com

+90264 295 7271

Other Identifiers

Hava Tetik Özel

Identifier Type: -

Identifier Source: org_study_id