The Effect of Two Different Interventions Applied During the Transfer of Children to the Operating Room for Circumcision on Fear, Anxiety, Comfort and Pain Levels

NCT07094555 | Not Yet Recruiting

• 1 other identifier: 81822950.903/142
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this randomized controlled experimental study was to determine the effects of two different interventions on fear, anxiety, comfort, and pain levels during the transfer of children undergoing circumcision to the operating room. The main questions it aims to answer are:

• H1: Animal-assisted intervention during transfer to the operating room affects children's fear.
• H2: Animal-assisted intervention during transfer to the operating room affects children's anxiety.
• H3: Animal-assisted intervention during transfer to the operating room affects children's comfort.
• H4: Animal-assisted intervention during transfer to the operating room affects children's pain.
• H5: Playing with a kaleidoscope during transfer to the operating room affects children's fear.
• H6: Playing with a kaleidoscope during transfer to the operating room affects children's anxiety.
• H7: Playing with a kaleidoscope during transfer to the operating room affects children's comfort.
• H8: Playing with a kaleidoscope during transfer to the operating room affects children's pain. Researchers will investigate the effects of animal-assisted intervention and kaleidoscopes on anxiety, fear, pain, and comfort during the transfer to the operating room in boys aged 7-10 undergoing circumcision. A comparison will be made with a control group to determine this effectiveness. Participants:
• The animal-assisted intervention group will initiate interaction with a goldfish in a portable aquarium during the preoperative period and accompany them until they arrive in the operating room.
• The kaleidoscope group will be distracted with a kaleidoscope during the preoperative period and continue this intervention until they arrive in the operating room.
• The control group will follow the hospital's routine patient transfer procedure.

Conditions

Male Circumcision

Keywords

Pain; Anxiety; Child; Kaleidoscope; Comfort; Fear; Animal Assisted Practice

Outcome Measures

Primary Outcomes (8)

• Animal-assisted therapy intervention applied during transfer to the operating room changes Child Anxiety Scale scores in the preoperative period.

  Child Anxiety Scale: The score that can be obtained from the scale varies between 0 and 10 points. As the score increases, the anxiety level also increases.

  10 minutes before surgery

• Animal-assisted therapy intervention applied during transfer to the operating room changes Child Fear Scale scores in the preoperative period.

  Child Fear Scale: The score that can be obtained from the scale varies between 0 and 4 points. As the score increases, the fear level also increases.

  10 minutes before surgery

• Animal-assisted therapy intervention applied during transfer to the operating room changes Wong-Baker pain scale scores in the postoperative period.

  Wong-Baker Pain Scale: The score that can be obtained from the scale varies between 0 and 10 points. As the score increases, the pain level also increases.

  up to the 1st postoperative hour

• Animal-assisted therapy intervention applied during transfer to the operating room changes Comfort Behaviors Checklist scores in the postoperative period.

  Comfort Behaviors Checklist: The score that can be obtained from the scale varies between 25 and 100 points. As the score increases, the comfort level also increases.

  up to the 1st postoperative hour

• Kaleidoscope intervention applied during transfer to the operating room changes Child Anxiety Scale scores in the preoperative period.

  Child Anxiety Scale: The score that can be obtained from the scale varies between 0 and 10 points. As the score increases, the anxiety level also increases.

  10 minutes before surgery

• Kaleidoscope intervention applied during transfer to the operating room changes Child Fear Scale scores in the preoperative period.

  Child Fear Scale: The score that can be obtained from the scale varies between 0 and 4 points. As the score increases, the fear level also increases.

  10 minutes before surgery

• Kaleidoscope intervention applied during transfer to the operating room changes Wong-Baker pain scale scores in the postoperative period.

  Wong-Baker Pain Scale: The score that can be obtained from the scale varies between 0 and 10 points. As the score increases, the pain level also increases.

  up to the 1st postoperative hour

• Kaleidoscope intervention applied during transfer to the operating room changes Comfort Behaviors Checklist scores in the postoperative period.

  Comfort Behaviors Checklist: The score that can be obtained from the scale varies between 25 and 100 points. As the score increases, the comfort level also increases.

  up to the 1st postoperative hour

Study Arms (3)

Animal Assisted Practice Group

EXPERIMENTAL

Behavioral: Animal Assisted Practice

Kaleidoscope Group

EXPERIMENTAL

Behavioral: Kaleidoscope

Control Group

NO INTERVENTION

Interventions

Animal Assisted Practice BEHAVIORAL

The animal-assisted intervention group initiated interaction with a goldfish in a portable aquarium during the preoperative period and accompanied them until they reached the operating room.

Animal Assisted Practice Group

Kaleidoscope BEHAVIORAL

The kaleidoscope group was distracted with a kaleidoscope during the preoperative period and continued this intervention until they reached the operating room.

Kaleidoscope Group

Eligibility Criteria

• Age: 7 Years - 10 Years
• Gender Eligibility Details: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• age group
• Circumcision performed under general anesthesia or sedation
• Pain level 0 before surgery
• Child has literacy skills
• Child and parent volunteer to participate in the study

You may not qualify if:

• The child has had previous surgical experience
• The child is allergic to fish products or fish meal
• The child has a special condition that may cause difficulty understanding and perceiving
• Any complications develop in the postoperative period
• The child and parent wish to withdraw from the study
• The child's hemodynamic instability

Sponsors & Collaborators

• MELİS CAN KESGİN GÜNGÖR: lead

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

MELİS CAN KESGİN GÜNGÖR

CONTACT

+905462932609; mls_kesgin@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 30, 2025
• Study Start: August 28, 2025
• Primary Completion: September 1, 2025
• Study Completion: March 1, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share