Distraction MethodsNo AcronymNCT07816965

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

A study testing External vibrating massage group and Digital Storytelling in people with Distraction Methods and Pain Management, run by Sinem Basdemir at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 3 to 6 yearsHealthy volunteers can take part
Conditions the study is for: Distraction Methods, Pain Management, Fear
What is being tested?: External vibrating massage group and Digital Storytelling
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 138 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Jun 2024to 30 Jun 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 6 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Izmir Bakircay University Cigli Training and Research Hospital
Izmir

Other trials in Turkey (Türkiye)

About this study

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

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

Conditions: Distraction Methods, Pain Management, Fear, Narration, Pediatric, Phlebotomy
Being tested: External vibrating massage group, Digital Storytelling
Keywords: Distraction, Fear, Narration, Pain, Pediatric, Phlebotomy
Medical subject headings: Agnosia, Narration, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

External vibrating massage groupOther
External vibrating massage application
Digital StorytellingOther
digital storytelling via tablet

Study groups in NCT07816965
Study group	Role	What they receive
Vibrating Massage Group	Experimental	External vibrating massage application Receives: Other: External vibrating massage group
Digital Storytelling Group	Experimental	digital storytelling via tablet Receives: Other: Digital Storytelling
Control Group	No intervention	no non-pharmacological intervention applied

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: During the phlebotomy procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202430 Jun 2025

First posted14 Sep 2026
Study start1 Jun 2024
Primary completion30 Jun 2025
Study completion30 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Distraction MethodsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 138 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07816965
Sponsor's protocol ID: EU-HEM-SB-02
Acronym: No Acronym
Status last verified: Sep 2026
First submitted: 2 Sep 2026
Last updated: 14 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Distraction Methods trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Dolphin Massage Device and Digital Storytelling on Pain and Fear During Phlebotomy in Children: A Randomized Controlled
ClinicalTrials.gov ID: NCT07816965
Acronym / sponsor ID: No Acronym / EU-HEM-SB-02
Conditions: Distraction Methods, Pain Management, Fear, Narration, Pediatric, Phlebotomy
Keywords: Distraction, Fear, Narration, Pain, Pediatric, Phlebotomy
Study type: Interventional
Recruitment status: Completed
Enrolment: 138 participants (actual)
Lead sponsor: Sinem BasdemirUniversity, hospital or other
Study start: 1 Jun 2024 (actual)
Primary completion: 30 Jun 2025 (actual)
Study completion: 30 Jun 2025 (actual)
First posted: 14 Sep 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3
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.

Arm	Type	Receives
Vibrating Massage Group	Experimental	Other: External vibrating massage groupExternal vibrating massage application
Digital Storytelling Group	Experimental	Other: Digital Storytellingdigital storytelling via tablet
Control Group	No intervention	–no non-pharmacological intervention applied

Who may qualify

Ages: 3 to 6 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (2 listed)

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

Key exclusion criteria (7 listed)

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,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
External vibrating massage groupExternal vibrating massage application	Other	Vibrating Massage Group
Digital Storytellingdigital storytelling via tablet	Other	Digital Storytelling Group

Primary outcome

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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
Background: PubMed 38029689Yaz 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.
Background: PubMed 41833093Kas 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.
Background: PubMed 41588469Akay 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.
BackgroundAbd 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 dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing External vibrating massage group and Digital Storytelling in people with Distraction Methods and Pain Management, run by Sinem Basdemir at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain intensity during phlebotomy (time frame: During the phlebotomy procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07816965, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.