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Two Different Therapeutic Interventions Applied During Blood Sampling in Children

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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07731347
Enrollment
105
Registered
2026-07-28
Start date
2026-08-01
Completion date
2026-12-01
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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. 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.

Detailed description

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. 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.

Interventions

COMBINATION_PRODUCTexperimental group

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

COMBINATION_PRODUCTexperiment group

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

COMBINATION_PRODUCTControl Group

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)

Sponsors

Igdir University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to 7 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
FLACC Pain Assessment Scalethrough study completion, an average of 1 yearThis 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.
Children's Fear Scalethrough study completion, an average of 1 yearThe 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.
Child Anxiety Scalethrough study completion, an average of 1 yearThe "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.

Countries

Turkey (Türkiye)

Contacts

CONTACTEda Gülbetekin, Assoc. Prof.
edagulbetekin@gmail.com05398612688

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026