Study Stopped
The study has been temporarily suspended due to a low volume of patient admissions and clinical encounters at the outpatient clinic during the summer period. Data collection is planned to resume once patient flow normalizes.
The Effect of Multisensory Stimulation During Venipuncture on Pain, Anxiety, and Fear in Children
1 other identifier
interventional
70
1 country
1
Brief Summary
Venipuncture is one of the most common and distressing needle-related procedures for children, often causing significant pain, fear, and anxiety. To minimize this procedural distress, effective non-pharmacological interventions are essential in pediatric nursing care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2025
CompletedFirst Submitted
Initial submission to the registry
August 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2026
CompletedFirst Posted
Study publicly available on registry
August 18, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
CompletedAugust 19, 2026
August 1, 2026
11 months
August 10, 2026
August 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Child's Pain Level
Wong Baker Facial Pain Rating Scale The scale was developed by Donna Wong and Connie Morain Baker in 1981 and revised in 2013. This scale is used to assess pain in children aged 3-18 years. The scale is rated from 0 to 10. 0 indicates no pain, while 10 indicates the most severe pain. Pain is assessed based on facial expression.
Baseline (upon arrival) and immediately before the clinical encounter (after multisensory stimulation).
Secondary Outcomes (1)
Child's Anxiety Level
Baseline (upon arrival) and immediately before the clinical encounter (after multisensory stimulation).
Other Outcomes (1)
Child's Fear Level
Baseline (upon arrival) and immediately before the clinical encounter (after multisensory stimulation).
Study Arms (1)
The Effect of Multisensory Stimulation During Venipuncture on Pain, Anxiety, and Fear in Children
EXPERIMENTALA Randomized Controlled Trial
Interventions
Happy Senso Therapy foam is a gel with multisensory properties. It stimulates the senses of touch, sight, hearing, and smell simultaneously in a fun way. It is a material used for sensory stimulation. It provides a cooling and fun effect that feels like "popping candy" on your skin. It evaporates at the end of the ses-sion, leaving no residue. It does not require washing. It has been dermatologically tested. It is paraben-free and hypoallergenic. It is used in therapy applications, as a work, play, and educational material. It is noted to be useful for increasing the child's attention span to the ac-tivity, boosting motivation, and reducing pain and fear. It helps increase interaction between the nurse and the child.
Eligibility Criteria
You may qualify if:
- Children aged 5 to 10 years
- Having passed at least 2 hours since the most recent painful procedure
- Provision of parental/guardian informed consent for participation
You may not qualify if:
- Presence of visual or hearing impairment
- Presence of intellectual/cognitive disability
- Absence or lack of signed Parental Informed Consent Form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bilecik Seyh Edebali University
Bilecik, Turkey, Turkey (Türkiye)
Related Publications (1)
No publications resulting from this study are available at this time as the trial is currently ongoing.
RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assis Prof Dr
Study Record Dates
First Submitted
August 10, 2026
First Posted
August 18, 2026
Study Start
October 1, 2025
Primary Completion
August 15, 2026
Study Completion
September 1, 2026
Last Updated
August 19, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share
Individual Participant Data (IPD) will not be made publicly available or shared for this study due to ethical considerations regarding participant confidentiality and the explicit terms of the informed consent protocol. Specifically: Informed Consent Constraints: The informed consent forms approved by the Institutional Review Board (IRB) / Ethics Committee and signed by the parents/guardians do not include permissions for raw, individual-level data sharing with external third parties or public repositories. Privacy and Vulnerability: Given that the study population consists of pediatric patients undergoing clinical evaluations, raw IPD contains sensitive demographic and clinical details that could potentially compromise participant anonymity. De-identified aggregate statistical data, protocol details, and final study findings will be made available through published peer-reviewed journal articles and clinical trial registries upon study completion.