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NCT Number: NCT07731347

Two Different Therapeutic Interventions Applied During Blood Sampling in Children

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. Group (Experiment 1): Distraction method using betta fish observation 2. Group (Experiment 2): Distraction method using hand puppets 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.

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Key information

Conditions

Blood Sampling Child, Only Fear Neurologic Manifestations Nurse's Role Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

5 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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:

  • Group (Experiment 1): Distraction method using betta fish observation
  • Group (Experiment 2): Distraction method using hand puppets
  • 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.

The obtained data will be compared using statistical analysis methods. The population of the study will consist of children aged 5-7 years who apply to the Pediatric Emergency Unit of Iğdır Dr. Nevruz Erez State Hospital and undergo venous blood sampling. The sample of the study will consist of children and their parents who meet the inclusion criteria and voluntarily agree to participate in the study. Children selected using an appropriate sampling method will be randomly assigned to three groups.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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.

Exclusion criteria

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.

Treatment and study plan

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

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

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)

Primary outcomes

  1. FLACC Pain Assessment Scale

    Time frame: through study completion, an average of 1 year

    This scale is a pain scale developed by Merkel et al. in 1997 to assess pain in children aged 2 months to 7 years (Merkel et al., 1997). 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.

  2. Children's Fear Scale

    Time frame: through study completion, an average of 1 year

    This scale was first developed by McMurtry et al. in 2011 (McMurtry et al., 2011). The Turkish validity study of the scale was conducted by Gerçeker et al. in 2018 (Gerçeker et al., 2018).

    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.

  3. Child Anxiety Scale

    Time frame: through study completion, an average of 1 year

    The Turkish validity and reliability study of the scale, developed by Ersig et al. (Ersig et al., 2013) in 2013, was 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. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Eda Gülbetekin, Assoc. Prof.

CONTACT

[email protected]

05398612688

Sponsors and collaborators

Lead sponsor

Igdir University

Other

Registry information

Official study title

The Effect of Two Different Therapeutic Interventions on Pain, Anxiety and Fear During Venipuncture in Children

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2026
Registry last updated
Jul 28, 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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