NCT07769385

Brief Summary

This study aims to find out whether robotic fish and aquarium fish can help reduce pain, fear, and anxiety in children during painful medical procedures. The main questions this study aims to answer are: Does watching robotic fish during a painful procedure reduce children's pain, fear, and anxiety? Does watching aquarium fish during a painful procedure reduce children's pain, fear, and anxiety? Are there differences in pain, fear, and anxiety between children receiving these interventions? During the painful procedure, children in the intervention groups will watch either robotic fish or aquarium fish as a distraction. Children's pain, fear, and anxiety levels will be assessed using age-appropriate measurement tools. Researchers will compare the results between the study groups to determine whether robotic fish or aquarium fish can help children feel more comfortable during painful medical procedures. The findings may provide information about simple, non-drug methods that nurses and other health care providers can use to help reduce children's negative experiences during painful procedures.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
2mo left

Started Jun 2026

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Jun 2026Dec 2026

Study Start

First participant enrolled

June 14, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

August 18, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

August 14, 2026

Last Update Submit

August 14, 2026

Conditions

Keywords

DistractionRobotic FishAnxietyPainChildren

Outcome Measures

Primary Outcomes (3)

  • Pain Level Assessed Using the Wong-Baker FACES Pain Rating Scale

    Children's pain intensity during the painful procedure will be assessed using the Wong-Baker FACES Pain Rating Scale. The scale ranges from 0 to 10, with higher scores indicating greater pain intensity.

    Immediately after completion of the painful procedure

  • Fear Level Assessed Using the Children's Fear Scale

    Children's procedure-related fear will be assessed using the Children's Fear Scale (CFS). The scale consists of five facial expressions representing increasing levels of fear and is scored from 0 to 4. A score of 0 indicates no fear and a score of 4 indicates extreme fear. Higher scores indicate greater fear.

    Immediately before the intervention and immediately after completion of the painful procedure

  • Anxiety Level Assessed Using the Children's Anxiety Meter-State

    Children's state anxiety related to the painful procedure will be assessed using the Children's Anxiety Meter-State (CAM-S). The scale is scored from 0 to 10, with higher scores indicating greater state anxiety.

    Immediately before the intervention and immediately after completion of the painful procedure

Study Arms (3)

Aquarium Fish Group

EXPERIMENTAL

hildren assigned to this group will watch live fish in an aquarium during the painful procedure as a distraction intervention.

Other: Robotic Fish

Control Group

NO INTERVENTION

No Intervention

Robotic Fish Group

EXPERIMENTAL

hildren assigned to this group will watch robotic fish during the painful procedure as a distraction intervention

Other: Robotic Fish

Interventions

Children assigned to this group will watch live fish swimming in an aquarium during the painful procedure. The aquarium will be used as a visual distraction to divert the child's attention from the procedure and potentially reduce pain, fear, and anxiety.

Aquarium Fish GroupRobotic Fish Group

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Being between the ages of 5 and 10, and
  • Being subjected to painful procedures.

You may not qualify if:

  • The child has a physical disability, and
  • There are circumstances that prevent the child's facial expressions from being clearly visible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bingöl State Hospital

Bingoel, Turkey, 12000, Turkey (Türkiye)

Location

Related Publications (13)

  • Power, N., Franck, L., & Oulton, K. (2019). The role of parental anxiety in children's procedural distress: A systematic review. Journal of Clinical Nursing, 28(23-24), 4357-4370.

    BACKGROUND
  • McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.

    PMID: 21806301BACKGROUND
  • Li WHC, Chung JOK, Ho KY, Kwok BMC. Play interventions to reduce anxiety and negative emotions in hospitalized children. BMC Pediatr. 2016 Mar 11;16:36. doi: 10.1186/s12887-016-0570-5.

    PMID: 26969158BACKGROUND
  • Koller D, Goldman RD. Distraction techniques for children undergoing procedures: a critical review of pediatric research. J Pediatr Nurs. 2012 Dec;27(6):652-81. doi: 10.1016/j.pedn.2011.08.001. Epub 2011 Oct 13.

    PMID: 21925588BACKGROUND
  • Kamioka H, Okada S, Tsutani K, Park H, Okuizumi H, Handa S, Oshio T, Park SJ, Kitayuguchi J, Abe T, Honda T, Mutoh Y. Effectiveness of animal-assisted therapy: A systematic review of randomized controlled trials. Complement Ther Med. 2014 Apr;22(2):371-90. doi: 10.1016/j.ctim.2013.12.016. Epub 2014 Jan 6.

    PMID: 24731910BACKGROUND
  • Hinic K, Kowalski MO, Holtzman K, Mobus K. The Effect of a Pet Therapy and Comparison Intervention on Anxiety in Hospitalized Children. J Pediatr Nurs. 2019 May-Jun;46:55-61. doi: 10.1016/j.pedn.2019.03.003. Epub 2019 Mar 7.

    PMID: 30852256BACKGROUND
  • Gerçeker, G. Ö., Binay, Ş., Bilsin, E., Kahraman, A., & Yılmaz, H. B. (2017). Turkish validity and reliability study of the Children's Anxiety Meter-State. Journal of Pediatric Nursing, 33, e29-e35.

    BACKGROUND
  • Gerçeker, G. Ö., Ayar, D., Özdemir, E. Z., Bektaş, M., & Conk, Z. (2018). The Turkish validity and reliability study of the Child Fear Scale. Journal of Pediatric Nursing, 40, e37-e40.

    BACKGROUND
  • Crossman, M. K., Kazdin, A. E., & Knudson, K. (2020). Brief unstructured interaction with a robotic animal reduces children's distress during medical procedures. Journal of Pediatric Nursing, 53, e75-e81.

    BACKGROUND
  • Cracknell D, White MP, Pahl S, Nichols WJ, Depledge MH. Marine Biota and Psychological Well-Being: A Preliminary Examination of Dose-Response Effects in an Aquarium Setting. Environ Behav. 2016 Dec;48(10):1242-1269. doi: 10.1177/0013916515597512. Epub 2015 Jul 28.

    PMID: 27818525BACKGROUND
  • Coyne I. Children's experiences of hospitalization. J Child Health Care. 2006 Dec;10(4):326-36. doi: 10.1177/1367493506067884.

    PMID: 17101624BACKGROUND
  • Birnie KA, Noel M, Parker JA, Chambers CT, Uman LS, Kisely SR, McGrath PJ. Systematic review and meta-analysis of distraction and hypnosis for needle-related pain and distress in children and adolescents. J Pediatr Psychol. 2014 Sep;39(8):783-808. doi: 10.1093/jpepsy/jsu029. Epub 2014 Jun 2.

    PMID: 24891439BACKGROUND
  • Bert F, Gualano MR, Camussi E, Pieve G, Voglino G, Siliquini R. Animal assisted intervention: A systematic review of benefits and risks. Eur J Integr Med. 2016 Oct;8(5):695-706. doi: 10.1016/j.eujim.2016.05.005. Epub 2016 May 20.

    PMID: 32362955BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersPain

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 14, 2026

First Posted

August 18, 2026

Study Start

June 14, 2026

Primary Completion

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

August 18, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations