ClinicalTrials.gg
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.

Primary conditionPainRegistry: NarrationReclassifiedWhy we changed it
Registry
Narration — the first condition term the registry derived for this study.
ClinicalTrials.gg
Pain
Why
  1. Narration is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Pain.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

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

From the registry’s dates

  • Registered 2 years 3 months after the study started (first participant enrolled Jun 2024, registered Sep 2026).
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

Browse trials for

Keywords

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

In context

Pain Reclassified

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's enrollment of 138 is above the median of 66 across 8,493 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Sinem Basdemir is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Compared within Pain, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Narration. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
3 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
05

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

06

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

07

Study locations

1 site
  • Izmir Bakircay University Cigli Training and Research Hospital
    Izmir, Turkey (Türkiye)
08

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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2024 to primary completion in Jun 2025, 12 months.

Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's 12 months is above that.

Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 2, 2026
First posted
Sep 14, 2026
StartActual
Jun 1, 2024
Primary completionActual
Jun 30, 2025
CompletionActual
Jun 30, 2025
Last update
Sep 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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