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NCT Number: NCT07094555

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

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.

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Key information

Conditions

Male Circumcision Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

7 year–10 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Kafkas University Faculty of Health Sciences

Merkez, Kars, 36100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 7-10 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Kaleidoscope

Behavioral

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

Primary outcomes

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

    Time frame: 10 minutes before surgery

    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.

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

    Time frame: 10 minutes before surgery

    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.

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

    Time frame: up to the 1st postoperative hour

    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.

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

    Time frame: up to the 1st postoperative hour

    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.

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

    Time frame: 10 minutes before surgery

    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.

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

    Time frame: 10 minutes before surgery

    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.

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

    Time frame: up to the 1st postoperative hour

    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.

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

    Time frame: up to the 1st postoperative hour

    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.

Sponsors and collaborators

Lead sponsor

MELİS CAN KESGİN GÜNGÖR

Other

Registry information

Official study title

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: Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 30, 2025
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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