Two Different Therapeutic Interventions Applied During Blood Sampling in Children

NCT07731347 | Not Yet Recruiting

• 1 other identifier: Eda4
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

This research is a three-group, randomized controlled experimental study designed to determine the effect of two different therapeutic interventions applied during blood sampling on pain, anxiety, and fear levels in children aged 5-7 years. Children participating in the study will be randomly divided into three groups:

1. 1.Group (Experiment 1): Distraction method using betta fish observation
2. 2.Group (Experiment 2): Distraction method using hand puppets
3. 3.Group (Control): Routine clinical practice (without any therapeutic intervention) Before, during, and after blood sampling, children's pain level (FLACC scale), fear level (child fear scale), and anxiety level (child anxiety scale) will be evaluated.

Conditions

Blood Sampling; Child, Only; Pain; Fear; Nurse's Role

Keywords

Play Therapy; blood sampling; child; pain; fear; nursing

Outcome Measures

Primary Outcomes (3)

• FLACC Pain Assessment Scale

  This scale is a pain scale assess pain in children aged 2 months to 7 years.It evaluates leg movements, facial expression, crying, and soothing ability and activity behaviors in relation to the pain experienced by the child. These behaviors are scored using a scale of 0, 1, and 2 points. A score of '0' indicates the absence of pain, '1-3' indicates mild pain, '4-6' indicates moderate pain, and '7-10' indicates the presence of severe pain.

  through study completion, an average of 1 year

• Children's Fear Scale

  The scale is designed for children aged 5 to 10 years. A talented graphic artist developed visual depictions showing changes in facial muscles associated with fear, using photographs of individuals with anxious facial expressions. The scale can be used by parents, children, or researchers to assess children's fear levels. The child is presented with a scale consisting of five facial expressions, each scored between "0" and "4". A score of "0" indicates a fearless, neutral expression, while "4" represents the highest level of fear. The scores progress as follows: "0" (neutral statement/no fear), "1" (very little fear), "2" (some fear), "3" (more fear) and "4" (highest possible fear). This scale can be used to measure fear both before and during the procedure.

  through study completion, an average of 1 year

• Child Anxiety Scale

  The "Child Anxiety Scale-State (CAS-S)," which resembles a thermometer with horizontal lines, is scored from 0 to 10. It is a scale developed for children aged 4-10 years. When the scale is introduced to the child, it is stated that there is no anxiety, that anxiety increases as the scale moves upwards, and that the anxiety level is very high at the top. Then, the child is asked to indicate the level of anxiety or tension they feel with a line. The scale, developed by Ersig et al. (Ersig et al., 2013) in 2013, had its Turkish validity and reliability study conducted by Gerçeker et al. in 2018 (Gerçeker et al., 2018). The "Child Anxiety Scale-State (CAS-S)," which resembles a thermometer with horizontal lines, is scored from 0 to 10. It is a scale developed for children aged 4-10 years.

  through study completion, an average of 1 year

Study Arms (3)

Experimental: experimental group

EXPERIMENTAL

Distraction method using betta fish observation Participation in the study is entirely voluntary. After the purpose of the study is explained to the experimental group by the researcher and written and verbal permission is obtained from those who voluntarily agree to participate in the study, the pre-test data will be collected by the researcher. 355 This research is a carefully planned, three-group, randomized controlled study designed to determine the levels of pain, anxiety, and fear experienced by children aged 5-7 years during blood sampling using two different therapeutic interventions. The working children will be randomly assigned to three groups: Group 1 (Experiment 1): Distraction method using betta fish observation

Combination Product: experimental group

Experimental: experimental 2 group

EXPERIMENTAL

Hand puppet distraction method This research is a carefully planned, three-group, randomized controlled study designed to determine the levels of pain, anxiety, and fear experienced by children aged 5-7 years during blood sampling with two different therapeutic interventions. The working children will be randomly assigned to three groups: Group 2 (Experiment 2): Hand puppet distraction method

Combination Product: experiment group

Experimental: Experimental: Control Group

EXPERIMENTAL

Standart of care This research is a carefully planned, three-group, randomized controlled trial to determine the levels of pain, anxiety, and fear experienced by children aged 5-7 years during blood sampling with two different therapeutic interventions. The working children will be randomly assigned to three groups: Group 3 (Control): Routine clinical practice (without any therapeutic intervention)

Combination Product: Control Group

Interventions

experimental group COMBINATION_PRODUCT

Before, during, and after blood sampling, the children's pain level (FLACC scale), fear level (child fear scale), and anxiety level (child anxiety scale) will be assessed. The obtained data will be compared using statistical analysis methods. Group 1 (Experiment 1): Distraction method using betta fish observation

Experimental: experimental group

experiment group COMBINATION_PRODUCT

Before, during, and after blood sampling, the children's pain level (FLACC scale), fear level (child fear scale), and anxiety level (child anxiety scale) will be assessed. The obtained data will be compared using statistical analysis methods. Group 2 (Experiment 2): Distraction method using hand puppets

Experimental: experimental 2 group

Control Group COMBINATION_PRODUCT

Before, during, and after blood sampling, the children's pain level (FLACC scale), fear level (child fear scale), and anxiety level (child anxiety scale) will be assessed. The obtained data will be compared using statistical analysis methods. Group 3 (Control): Routine clinical practice (without any therapeutic intervention)

Experimental: Experimental: Control Group

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Being between 5 and 7 years old,
• Having a scheduled venous blood sampling procedure in the Pediatric Emergency Unit,
• Having a level of consciousness suitable for communication,
• The child and their parents agreeing to participate in the study,
• Being able to communicate in Turkish.

You may not qualify if:

• Inability to participate in the application due to visual or hearing problems,
• Inability to administer the scales due to a developmental or neurological disease,
• Being under the influence of sedative or analgesic medication,
• Inability to complete the application during the research process,
• Lack of parental consent.

Sponsors & Collaborators

• Igdir University: lead

Study Sites (1)

Igdır University

Iğdır, Iğdır, 76000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Eda Gülbetekin, Assoc. Prof.

CONTACT

05398612688; edagulbetekin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

TU (1)