A Clown Accompanying Children During Blood Collection

NCT06252766 | Completed DMC

• 1 other identifier: NecmettinEUHemSK
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Children may be exposed to acute and chronic illnesses during their development and may experience negative emotions and They may be exposed to experiences. For the purpose of diagnosis and treatment in a child admitted to hospital due to illness blood sampling causes pain and anxiety. To reduce pain and anxiety pharmacologic and nonpharmacologic methods are preferred in children. Nonpharmacologic methods supportive, cognitive and physical, although they are more preferred than pharmacological methods in order to classify them as such. Various methods are used within the scope of these classifications, among which The method of distraction is more preferred. This study is based on distraction the effect of the clown, which is one of the methods, on pain and anxiety during blood sampling. to determine the impact of the project. It is planned to be conducted as a randomized controlled study and in this study, 5-12 years old with children between the ages of 18 and 18, and the Pediatric Outpatient Clinic at Necmettin Erbakan University Faculty of Medicine. It was planned to be conducted in the blood collection unit. Minimum number of children to be included in the study The intervention group was planned as 28 and the control group as 28, but due to the possibility of data loss, 15 To collect more data, the number of children to be recruited for both groups is targeted to be 32-33. Children will be randomly assigned to the groups and the assignment to the groups will be based on 'stratification and blocked randomization methods' were planned to be used. Sociodemographic characteristics in data collection form, Wong-Baker Faces Pain Scale (WBFPS), Child Anxiety Scale-Dispositional (CAS-D) scales were planned to be used. Obtaining necessary institutional permissions by the researcher and project advisor It is planned to start the project after it is ensured. Research data were collected through face-to-face interviews with the 'Informed Consent Form'. Family 'Informed Voluntary Consent Form' about the research will be informed. In the intervention group, the blood collection process will be carried out with foamy bubbles accompanied by a clown. by playing with the parents. No treatment was applied to the control group and the parents blood sampling will be performed in the presence of the child. Both groups will be administered the WBFPS and CAS-D scales, will be administered by both the researcher and the parent. The research results to be obtained will be published in international SSCI and/or SCI publishing them as scientific articles in journals, organizing national and international conferences, symposiums and contributing to the literature as a result of being presented in seminars, raising awareness in this field, creating a It is aimed to shed light on future research.

Conditions

Child; Therapeutic Play

Keywords

Blood collection; clown; pain; anxiety; pediatric nursing

Outcome Measures

Primary Outcomes (1)

• Sociodemographic Characteristics Form

  In this section, children's descriptive characteristics (age, gender, mother's education level, father's education level, most the time of the last blood collection, the presence of the parent with the child during the blood collection process) is taking.

  It will be applied for 1-2 minutes after the blood collection is completed.

Secondary Outcomes (1)

• Wong-Baker Faces Pain Scale (WBFPS)

  It will be applied for 1-2 minutes after the blood collection is completed.

Other Outcomes (1)

• Child Anxiety Scale-Dispositional (CAS-D)

  It will be applied for 1-2 minutes after the blood collection is completed.

Study Arms (2)

Experiment (Clown)

EXPERIMENTAL

During this process, the clown will continue to distract the children by playing games and blowing foam balloons. During the procedure, the child's pain and anxiety score will be evaluated by both the researcher, the parent, and the child. After the procedure is completed, children will be taken out of the blood collection room and taken to the waiting area in the next room, and after being allowed to rest for 1-2 minutes, surveys will be administered to the children.

Behavioral: Experiment (Clown)

Control

NO INTERVENTION

Blood collection will be routine and surveys will be administered 1-2 minutes after the end of the procedure to determine the level of pain and anxiety during the procedure.

Interventions

Experiment (Clown) BEHAVIORAL

Children included in the intervention group will be accompanied by a clown at the door from the moment they enter the intervention room and The child will be made to sit on the blood collection chair by playing games with them. Meanwhile, the nurse will take blood from the child. lasts for about 2-3 minutes. During this process, the clown is constantly playing games and foam will continue to distract you by blowing up balloons. The child's pain and anxiety score during the procedure the researcher will be evaluated by both the parent and the child. After the procedure is finished, the children will be will be taken out of the room and taken to the waiting area in the next room. Afterwards, the children will be asked how much pain and anxiety they felt during the blood collection procedure. After being allowed to rest for 1-2 minutes a questionnaire form will be applied to the children.

Experiment (Clown)

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Between the ages of 5-12,
• Volunteering to participate in the research

You may not qualify if:

• Having any physical and mental disability

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan Üniversitesi Hemşirelik Fakültesi

Konya, Meram, 42250, Turkey (Türkiye)

Location

Related Publications (1)

• Keskin, E. , Buldur, E. & Bal Yılmaz, H. (2021). Virtual Reality in Pain Management in Pediatric Patients Effectiveness of Practices: A Systematic Review . Journal of Current Nursing Research,1(3),96-106 .Retrieved from https://dergipark.org.tr/tr/pub/jcnr/issue/68806/1077642 Kürtüncü, M., & Davas, S. (2020). Nonpharmacologic nonpharmacologic anesthesia during blood sampling in children. the use of methods. Journal of Human Sciences, 17(2), 710-719. doi:10.14687/jhs.v17i2.5785 711 Tsao, Jennie C. I., and Lonnie K. Zeltzer. 2008.

  BACKGROUND

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Semra KÖSE, PhD,RN

  Necmettin Erbakan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Trio (Researcher, Child and Parent) The researcher, the child and the parent, who knows the groups and waives all rights to the research, will evaluate the children's pain and anxiety levels during the procedure.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asisstant Proffessor

Model Details: The research is a randomized controlled experimental type study.

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 12, 2024
• Study Start: December 15, 2023
• Primary Completion: January 30, 2024
• Study Completion: February 25, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)