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CompletedNCT07816965No AcronymUpdated Sep 14, 2026

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

An interventional study of External vibrating massage group and Digital Storytelling in Distraction Methods, Pain Management and Fear, sponsored by Sinem Basdemir. Completed at 1 site in Turkey (Türkiye). Open to participants aged 3 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Sinem Basdemir · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
138
Allocation
Randomized
Ages
3 Years to 6 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

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Keywords

  • Distraction
  • Fear
  • Narration
  • Pain
  • Pediatric
  • Phlebotomy
03

Who can participate

Ages eligible
3 Years to 6 Years
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
138 participants (actual)

Study arms

  • Experimental
    Vibrating Massage Group

    External vibrating massage application

    Other: External vibrating massage group

  • Experimental
    Digital Storytelling Group

    digital storytelling via tablet

    Other: Digital Storytelling

  • No intervention
    Control Group

    no non-pharmacological intervention applied

Interventions

  • OtherExternal vibrating massage group

    External vibrating massage application

  • OtherDigital Storytelling

    digital storytelling via tablet

05

What researchers measure

Primary outcomes

  1. Pain intensity during phlebotomy

    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.

    Time frame: During the phlebotomy procedure

  2. Fear during phlebotomy

    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.

    Time frame: During the phlebotomy procedure

06

Study locations

1 site
  • Izmir Bakircay University Cigli Training and Research Hospital
    Izmir, Turkey (Türkiye)
07

References and documents

Publications

  • Yaz SB, Basdemir S, Gectan E. The effect of vibrating cold application and puppet use on pain and fear during phlebotomy in children: A randomized controlled study. J Pediatr Nurs. 2024 Jan-Feb;74:77-84. doi: 10.1016/j.pedn.2023.11.018. Epub 2023 Nov 28. PubMed 38029689 ↗
  • Kas Alay G, Acilan S, Catan Inan F, Yildiz E. Effect of therapeutic storytelling on intramuscular injection-related pain, anxiety, and fear in children: A randomized controlled trial. J Pediatr Nurs. 2026 May-Jun;88:422-428. doi: 10.1016/j.pedn.2026.03.007. Epub 2026 Mar 15. PubMed 41833093 ↗
  • Akay G, Guducu Tufekci F. Storytelling Intervention Relieved Pain During Tracheostomy Suction in Children Under Palliative Care: A Randomised Controlled Trial. Scand J Caring Sci. 2026 Mar;40(1):e70182. doi: 10.1111/scs.70182. PubMed 41588469 ↗
  • Abd Elmoniem Syan, S., Galeon Ocampo, J., Aquino Abundo, R., Said Gouda Ahmed, S., & Saber Ghaly, A. (2021). Effect of storytelling versus cartoon on pain and fear relief among children undergoing venipuncture. Egyptian Journal of Health Care, 12(4), 399-408. https://doi.org/10.21608/ejhc.2021.200063

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07816965
Lead sponsor
Sinem Basdemir
Responsible party
Sinem Basdemir (Assistant Professor, Ege University) — Sponsor-investigator
First posted
Sep 14, 2026
Start date
Jun 1, 2024
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025
Last update
Sep 14, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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