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Completed

NCT Number: NCT07816965

The Effects of Two Methods Applied on Pain and Fear During Phlebotomy in Children

Objective: This study aimed to evaluate the effects of using an externally vibrating dolphin-shaped Dolphin massage device and digital storytelling via tablet on pain and fear in children aged 3 to 6 years during blood collection. Method: This randomized controlled trial was conducted with 105 children aged 3-6 years who visited the pediatric blood collection unit of a training and research hospital between June 2024 and June 2025. This study used the CONSORT checklist. After obtaining consent from the child and parent, the children (n=105) were assigned to one of the groups (Dolphin massage device group (n=35), digital storytelling group (n=35), control group (n=35)) using block randomization. The children's pain and fear scores were assessed after phlebotomy by their parents, the nurse performing the phlebotomy, and the researcher using the Wong-Baker Pain Scale and the Child Fear Scale. The phlebotomy procedure was performed by a single nurse.

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Key information

Conditions

Distraction Methods Agnosia Behavior Communication Fear Narration Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain Management Pathological Conditions, Signs and Symptoms Pediatric Perceptual Disorders Phlebotomy Signs and Symptoms

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Izmir Bakircay University Cigli Training and Research Hospital

Izmir, Turkey (Türkiye)

About this study

Objective: This study aimed to evaluate the effects of using an externally vibrating dolphin-shaped Dolphin massage device and digital storytelling via tablet on pain and fear in children aged 3 to 6 years during blood collection. Method: This randomized controlled trial was conducted with 105 children aged 3-6 years who visited the pediatric blood collection unit of a training and research hospital between June 2024 and June 2025. This study used the CONSORT checklist. After obtaining consent from the child and parent, the children (n=105) were assigned to one of the groups (Dolphin massage device group (n=35), digital storytelling group (n=35), control group (n=35)) using block randomization. The children's pain and fear scores were assessed after phlebotomy by their parents, the nurse performing the phlebotomy, and the researcher using the Wong-Baker Pain Scale and the Child Fear Scale. The phlebotomy procedure was performed by a single nurse.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Children whose parents and themselves agree to participate in the study
  • Children from whom blood was successfully drawn on the first attempt

Exclusion criteria

  • Children with chronic illnesses,
  • Children with intellectual disabilities,
  • Children who have received analgesics in the last 24 hours,
  • Children who have undergone surgery,
  • Children who are hospitalized,
  • Children from whom blood could not be drawn on the first attempt
  • Children who do not agree to participate in the study

Treatment and study plan

External vibrating massage group

Other

External vibrating massage application

Digital storytelling

Other

digital storytelling via tablet

Primary outcomes

  1. Pain intensity during phlebotomy

    Time frame: During the phlebotomy procedure

    Pain intensity was assessed during the phlebotomy procedure using the Wong-Baker Faces Pain Rating Scale. Children rated their pain on a scale ranging from 0 (no pain) to 10 (worst pain). The scale includes six facial expressions ranging from "0" (smiling, "cruel"), 1-2 (hurts a little), 3-4 (hurts a little more), 5-6 (hurts even more), 7-8 (hurts a lot), and 9-10 (hurts the worst). It provides a 0-10 rating for assessing acute pain in children. It does not require verbal or numerical skills. Scores obtained from the scale are directly proportional to pain tolerance.

  2. Fear during phlebotomy

    Time frame: During the phlebotomy procedure

    Fear was measured using the Child Fear Scale. The scale includes 5 different facial expressions. This scale is scored from 0 to 4 and is a reliable and valid measurement tool for assessing fear. As the score obtained from the scale increases, fear increases.

Sponsors and collaborators

Lead sponsor

Sinem Basdemir

Other

Registry information

Official study title

The Effects of Dolphin Massage Device and Digital Storytelling on Pain and Fear During Phlebotomy in Children: A Randomized Controlled

Acronym: No Acronym

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 14, 2026
Registry last updated
Sep 14, 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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