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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07816965
Acronym
No Acronym
Enrollment
138
Registered
2026-09-14
Start date
2024-06-01
Completion date
2025-06-30
Last updated
2026-09-14

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

Conditions

Distraction Methods, Fear, Narration, Pain Management, Pediatric, Phlebotomy

Keywords

Distraction, Fear, Narration, Pain, Pediatric, Phlebotomy

Brief summary

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.

Detailed description

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.

Interventions

OTHERExternal vibrating massage group

External vibrating massage application

digital storytelling via tablet

Sponsors

Sinem Basdemir
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

This randomized controlled trial was conducted with 105 children aged 3-6 years who came to the pediatric blood sampling unit of a training and research hospital. After obtaining consent from the child and parent, the children (n=105) were randomly assigned to one of the groups (Dolphin massage device group (n=35), digital storytelling group (n=35), control group (n=35)). 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.

Eligibility

Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pain intensity during phlebotomyDuring the phlebotomy procedurePain 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.
Fear during phlebotomyDuring the phlebotomy procedureFear 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026