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

NCT07816965 | Completed

• 1 other identifier: EU-HEM-SB-02
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Distraction; Fear; Narration; Pain; Pediatric; Phlebotomy

Outcome Measures

Primary Outcomes (2)

• 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.

  During the phlebotomy procedure

• 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.

  During the phlebotomy procedure

Study Arms (3)

Vibrating Massage Group

EXPERIMENTAL

External vibrating massage application

Other: External vibrating massage group

Digital Storytelling Group

EXPERIMENTAL

digital storytelling via tablet

Other: Digital Storytelling

Control Group

NO INTERVENTION

no non-pharmacological intervention applied

Interventions

External vibrating massage group OTHER

External vibrating massage application

Vibrating Massage Group

Digital Storytelling OTHER

digital storytelling via tablet

Digital Storytelling Group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sinem Basdemir: lead

Study Sites (1)

Izmir Bakircay University Cigli Training and Research Hospital

Izmir, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 38029689 BACKGROUND

• 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.

  PMID: 41833093 BACKGROUND

• 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.

  PMID: 41588469 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Agnosia; Narration; Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Communication; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 14, 2026
• Study Start: June 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)