NCT05252494

Brief Summary

Disease patterns are different from adults due to the fact that the abstract thinking and cause-effect abilities of children in the 3-6 age group are not developed. Children in this age group; Their ability to cope with stress is limited due to the need for special care, life experiences, mental development and inadequate ability to express themselves verbally (Conk et al, 2013). Illness is a source of pain and stress for them due to external factors and is a punishment for their bad behavior (Conk et al, 2013; Teksöz \& Ocakçı, 2014).Hospital, on the other hand, means foreign environment/persons, loss of independence, loss of privacy, painful procedures, disruption of daily routines, surgery, pain, disability, death, separation from family and friends for children (Conk et al, 2013). Blood collection and vascular access are the interventions that cause the most pain, stress and anxiety in hospitalized children (Duff, 2003; Caprilli et al, 2007) . Non-invasive non-pharmacological methods increase the release of endorphins, the body's natural morphine, and relieve pain, thereby reducing the stress and anxiety of the child and family (Bergomi et al, 2018). Clinical experience argues that human-animal bonding, which is one of the distraction practices in pain management, is effective in reducing pain and stress (Muslu, 2011; Min \& Zaw 2016; Alvarez et al, 2020) . In the light of all this information; The aim of this study was to determine the effect of watching small aquarium fish, which is used as a distraction method during the blood collection process, on the pain and stress, heart rate and oxygen saturation during the procedure in children aged 3-6 years who applied to the blood collection unit. Hypotheses of the Research: Hypothesis 0 (H0): Feelings felt by children watching and not watching fish during blood collection there was no difference between stress, pain score, heart rate, oxygen saturation, crying and procedure time. Hypothesis 1 (H1): The oxygen saturation of the children who watched the fish during the blood collection process is high. Hypothesis 2 (H2): Children watching the fish during the blood draw have a higher heart rate is low. Hypothesis 3 (H3): Children who watched the fish during the blood draw had a higher pain score is low. Hypothesis 4 (H4): The stress score of the children who watched the fish during the blood collection process was higher is low. Hypothesis 5 (H5): The crying time of the children watching the fish during the blood collection process is longer is short. Hypothesis 6 (H6): The processing time is longer for children watching the fish during the blood collection process is short.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Status
unknown

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

First Submitted

Initial submission to the registry

January 11, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

February 23, 2022

Status Verified

February 1, 2022

Enrollment Period

1 year

First QC Date

January 11, 2022

Last Update Submit

February 12, 2022

Conditions

Keywords

Pain managementanimal assisted therapyAquarium FishBlood CollectionPhysiological ParametersStress

Outcome Measures

Primary Outcomes (7)

  • Differences in physiological parameters

    Differences in oxygen saturation

    1 year

  • Differences in physiological parameters

    Differences in heart rate

    1 year

  • Differences in pain score

    Pain Assessment Tool (FLACC): The items take the value 0, 1, 2, respectively, and the total score is between 0 and 10. A "0" score indicates no pain, 1-3 points mild, 4-6 points moderate and 7-10 points severe pain.

    1 year

  • Differences in pain score

    Wong and Baker Faces Pain Scale \[Wong-Baker Faces Pain Rating Scale (WBFPRS): The lowest score is "1" and the highest score is "5". As the score obtained from the scale increases, the pain tolerance decreases, and as the score decreases, the tolerance increases.

    1 year

  • Differences in stress

    Children's Emotional Manifestation Scale-CEMS: Scale consists of a total of 5 different categories and 25 items. As the score obtained from the scale increases, the pain tolerance decreases, and as the score decreases, the tolerance increases.

    1 year

  • Differences in crying time

    Crying time will be measured by chronometer (second/minute)

    1 year

  • Differences in procedure time

    Prosedure time will be measured by chronometer (second/minute)

    1 year

Study Arms (2)

animal assisted therapy group

EXPERIMENTAL

Animal assisted therapy group will watch aquarium fish while bloodletting prosedure.

Other: animal assisted therapy

Control Group

NO INTERVENTION

Control group will not watch aquarium fish while bloodletting prosedure.

Interventions

In the intervention group, the child will be given to the mother's lap just before the invasive procedure. During the process, the aquarium with the fish will be placed on a shelf at a distance of about 50-60 cm, at an angle that the child can see. The camera on which the blood collection will be recorded will be placed on a tripod and placed on another shelf in such a way that the child can be seen completely. A video recording will be started 1 minute before the procedure, a pulse oximeter device will be attached to the child immediately after the child is seated on his mother's lap, physiological parameters, pain scores and stress will be determined. During the procedure, children's physiological measurements pain score and stress will be re-evaluated after the needle is inserted into the site. After the procedure, children's physiological measurements pain score and stress will be re-evaluated 1 minute after the needle is removed from the injection site

animal assisted therapy group

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Parents' willingness to participate in the research is in line with the voluntary consent form have obtained written consent from their parents,
  • The child is between 3-6 years old,
  • The child musn't not have fish,
  • No blood sampling has been performed in the last year,
  • If the child is considered healthy as a result of the examination performed by the doctor,

You may not qualify if:

  • if The child has fish
  • To have taken analgesic medication 4 hours before the procedure
  • if The child is afraid of fish,
  • The child has a known allergy history,
  • Deterioration of skin integrity in the blood collection area,
  • ifThe child has a visual/hearing disability.
  • if The child has developmental delay, mental problems
  • if there is Failure of blood collection in the first attempt.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • Teksöz, E. Ocakçı, A. F. Çocuk Hemşireliği'nde Sanat Uygulamaları. Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Dergisi.2014; 7(2): 119- 123.

    BACKGROUND
  • Duff AJ. Incorporating psychological approaches into routine paediatric venepuncture. Arch Dis Child. 2003 Oct;88(10):931-7. doi: 10.1136/adc.88.10.931.

    PMID: 14500318BACKGROUND
  • Bergomi P, Scudeller L, Pintaldi S, Dal Molin A. Efficacy of Non-pharmacological Methods of Pain Management in Children Undergoing Venipuncture in a Pediatric Outpatient Clinic: A Randomized Controlled Trial of Audiovisual Distraction and External Cold and Vibration. J Pediatr Nurs. 2018 Sep-Oct;42:e66-e72. doi: 10.1016/j.pedn.2018.04.011. Epub 2018 May 1.

    PMID: 29728296BACKGROUND
  • Caprilli S, Anastasi F, Grotto RP, Scollo Abeti M, Messeri A. Interactive music as a treatment for pain and stress in children during venipuncture: a randomized prospective study. J Dev Behav Pediatr. 2007 Oct;28(5):399-403. doi: 10.1097/DBP.0b013e31811ff8a7.

    PMID: 18049324BACKGROUND
  • Muslu, G. K. Conk, K. Hayvan Destekli Uygulamalar Ve Çocuklarda Kullanımı. Deuhyo Ed 2011, 4 (2), 83-88.

    BACKGROUND
  • Min, M. Zaw, C.C. A Review On Animal-Assisted Therapy And Activities For Healthcare And Teaching Of Children. Journal Of Education And Social Sciences.2016;(3), 40-46.

    BACKGROUND
  • Avila-Alvarez A, Pardo-Vazquez J, De-Rosende-Celeiro I, Jacome-Feijoo R, Torres-Tobio G. Assessing the Outcomes of an Animal-Assisted Intervention in a Paediatric Day Hospital: Perceptions of Children and Parents. Animals (Basel). 2020 Oct 1;10(10):1788. doi: 10.3390/ani10101788.

    PMID: 33019696BACKGROUND
  • Conk Z, Başbakkal Z, Bal Yılmaz H, Bolışık B. Pediatri Hemşireliği. Akademisyen Tıp Kitabevi, Ankara, 2013.

    BACKGROUND
  • Braun C, Stangler T, Narveson J, Pettingell S. Animal-assisted therapy as a pain relief intervention for children. Complement Ther Clin Pract. 2009 May;15(2):105-9. doi: 10.1016/j.ctcp.2009.02.008. Epub 2009 Mar 3.

    PMID: 19341990BACKGROUND
  • Yanık, M. Kuzlu Ayyıldız, T. Kulakçı Altıntaş, H. Çocukların Duygusal Dışa Vurumunu Değerlendirme Ölçeği: Geçerlik Ve Güvenirlik Çalışması. Anadolu Hemşirelik Ve Sağlık Bilimleri Dergisi, 2019; 22(3): 179-188

    BACKGROUND
  • Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.

    PMID: 9220806BACKGROUND
  • Şenaylı, Y. Özkan, F. Şenaylı, A. Bıçakçı, Ü. Çocuklarda Postoperatif Ağrının FLACC (YBAAT) Ağrı Skalasıyla Değerlendirilmesi. Turkiye Klinikleri J Anest Reanim. 2006;4(1):1-4

    BACKGROUND
  • Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available.

    PMID: 3344163BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Animal Assisted Therapy

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPsychotherapyBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
In this study, the Urn method, which is a randomization method equivalent to the full randomization method, will be used to determine the groups. In this randomization method, there are two parameters such as α and β. These parameters represent balls of two different colors, red and white. As a result of the lottery drawn in the research, the white ball will represent the "Animal assisted treatment group, and the red colored ball will represent the "Control Group". When there is a child who meets all the sampling criteria, the balls previously prepared by the researcher will be placed in a black bag and selection will be made by the nurse practitioner with their eyes closed. According to the color of the selected ball, it will be assigned to the child group, so that the children will be randomly distributed to the two groups.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The research consists of 2 groups as experimental and control group. In the experimental group, the children who watched the fish during the bloodletting process comprised the animal-assisted treatment group, and the control group consisted of the children who underwent routine bloodletting.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 11, 2022

First Posted

February 23, 2022

Study Start

March 1, 2022

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

February 23, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share