ClinicalTrials.gg
SuspendedNCT07769775Updated Aug 19, 2026

The Effect of Multisensory Stimulation During Venipuncture on Pain, Anxiety, and Fear in Children

An interventional study of Multisensory stimulation in Multisensory Stimulation, Pain and Venipuncture Pain, sponsored by Bilecik Seyh Edebali Universitesi. Suspended at 1 site in Turkey (Türkiye). Open to participants aged 5 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Bilecik Seyh Edebali Universitesi · Not applicable, Interventional, and Health services research

Why this study was suspended
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.

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Oct 2025, registered Aug 2026).

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Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
5 Years to 10 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 1,714 studies in Pain with a site in Turkey — 322 open to participants now, 372 under way, none of them phase 3. Pain · Turkey.

Planned enrollment
704th of 1,491
70 · median 70
Started
2025
with 279 others
No phase
1,449 of 1,714
260 open now
Registered
1,646th of 1,714
by date

Among the 1,714 studies in Pain with a site in Turkey, this one is the 704th largest by planned enrollment of the 1,491 interventional ones that give a count, is one of 280 that started in 2025, is one of 1,449 with no phase, and was the 1,646th registered.

Pain

10,060 studies on the registry are indexed under Pain; 1,651 are open to participants now.

Browse Pain studies →

Open to participants now

322 of the 1,714 studies in Pain with a site in Turkey are open now. Recruiting first, the newest first:

317 more — sign in →

All 322 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 929 Pain studies recruiting now, 384 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.

This study: 5 Years to 10 Years · all sexes · healthy volunteers too.

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02

Study 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.

Read the detailed description

Children encounter many situations in the hospital environment that trigger pain, fear, and anxiety. The unfamiliarity of the physical environment, the appearance of medical devices, interventions by healthcare professionals, and the unpredictability of routine procedures are cited as important factors that increase children's levels of pain, fear, and anxiety. Children with chronic illnesses, in particular, face numerous painful procedures during diagnosis, treatment, and follow-up, while healthy children also experience pain due to reasons such as venipuncture and repeated invasive procedures. Venipuncture, one of the most commonly used and fundamental procedures in healthcare delivery, can be a traumatic experience, especially for children.This procedure can cause intense pain, anxiety, and fear in children, leading to negative psychological reactions in the short term and the development of negative attitudes toward healthcare services in the long term.The literature indicates that such negative attitudes not only adversely affect the success of the procedure but also manifest themselves in the child as physical resistance, crying, avoidance behavior, and increased physiological stress indicators.These behavioral and physiological responses can lead to problems for healthcare professionals, such as prolonged procedure times, multiple attempts, and increased procedural complexity; this situation can cause anxiety for both the child and the healthcare worker. Furthermore, it has been reported that negative experiences during painful procedures such as venipuncture can lead to psychosocial consequences in children, including long-term fear, avoidance of medical procedures, needle phobia, and the formation of traumatic memories. The high levels of anxiety and fear experienced by children during this process can reduce their compliance with healthcare services in later years and lead to mistrust of healthcare professionals. Numerous studies in the literature have determined that the anxiety and fear experienced by children during venipuncture are among the key factors that significantly affect the quality of the procedural process .Therefore, reducing pain, fear, and anxiety that may develop during venipuncture in children is critically important for both protecting the child's short- and long-term well-being and increasing the effectiveness of clinical practice. Although venipuncture is a painful medical procedure, it is one of the situations that causes significant anxiety and fear in children in a hospital setting.Research in the literature on non-pharmacological methods to control pain and reduce anxiety and fear suggests the use of multisensory stimulation to distract children and create a happy and motivating atmosphere.

Multisensory stimulation is a non-pharmacological method that aims to support a child's developmental stages using stimulating materials targeting the senses of sight, hearing, smell, and touch, with the goal of reducing behavioral problems, pain, and fear.The basic mechanism of multisensory stimulation is to provide multiple stimuli by continuously activating the tactile, thermal, and emotional systems. This simultaneous stimulation of various sensory systems leads to sensory saturation. This activates the gate control mechanism to close the gates, thereby weakening or suppressing nociceptive transmission. Thus, the gate control mechanism reduces or eliminates pain by closing the gates to prevent the entry of nociceptive signals. Multiple sensory stimulation practices include mother-infant communication, skin-to-skin contact, breastfeeding that activates skin sensory receptors and the sense of taste, and allowing the infant to smell familiar scents such as breast milk, amniotic fluid, or aromatic scents. Establishing eye contact with the infant, speaking in a soft tone of voice, massage, swaddling, and using the parent's scent are also among the multisensory stimulation practices.

Non-pharmacological methods are known to be effective in reducing pain in children and to increase the effectiveness of medications when used in combination with analgesics.Non-pharmacological methods are preferred because they are easy to apply and inexpensive, reducing the need for medication and thus the risk of side effects. Knowing the effects of pain and the associated fear and anxiety on children, developing appropriate pain control strategies is both a medical and ethical responsibility. A review of the literature reveals that there is very little scientific evidence that multisensory stimulation is an effective intervention for reducing pain, fear, and anxiety in children during venipuncture.Recent research in the literature on non-pharmacological methods for pain control and reducing anxiety and fear recommends the use of multisensory stimulation in children. Some studies have examined the effects of multisensory stimulation applications on children's health. These studies have mostly focused on the effects during the neonatal period.Although there are a limited number of studies aimed at reducing pain, fear, and anxiety during venipuncture in children, these studies are limited to methods that focus on only one sense or at most two sensory stimuli.Therefore, our study contributes to the limited literature evaluating the effect of multisensory stimulation by using Happy Senso Therapy foam, which simultaneously stimulates the senses of touch, sight, hearing, and smell. In this context, the aim of our study is to examine the effect of multisensory stimulation applied during venipuncture in children on pain, anxiety, and fear.

03

Conditions studied

  • Multisensory Stimulation
  • Pain
  • Venipuncture Pain
  • Fear

Keywords

  • child
  • pain
  • fear
  • anxiety
  • venipuncture
  • multisensory stimülation
04

Who can participate

Ages eligible
5 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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Inclusion criteria

  • Children aged 5 to 10 years
  • Having passed at least 2 hours since the most recent painful procedure
  • Provision of parental/guardian for participation

Exclusion criteria

Exclusion Criteria:

  • Presence of visual or hearing impairment
  • Presence of intellectual/cognitive disability
  • Absence or lack of signed Parental Form
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    The Effect of Multisensory Stimulation During Venipuncture on Pain, Anxiety, and Fear in Children

    A Randomized Controlled Trial

    Other: Multisensory stimulation

Interventions

  • OtherMultisensory stimulation

    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.

06

What researchers measure

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.

    Time frame: Baseline (upon arrival) and immediately before the clinical encounter (after multisensory stimulation).

Secondary outcomes

  1. Child's Anxiety Level

    It assesses children's anxiety in clinical settings and before medical procedures. The Child Anxiety Meter (CAM) is drawn like a thermometer with a bulb at the bottom and also contains horizontal lines spaced upward. Children are asked to mark how they feel "right now" to measure state anxiety (CAM-S).Scores range from 0 to 10. It has been validated in children aged 4-10 years during an intravenous procedure. CAM-S scores were significantly correlated with all parent measures and observed distress ratings. The psychometric properties of CAM in the Turkish population were examined by Özalp Gerçeker and colleagues (2018), who found a significant negative correlation between children's anxiety scores and their age.

    Time frame: Baseline (upon arrival) and immediately before the clinical encounter (after multisensory stimulation).

Other outcomes

  1. Child's Fear Level

    The Child Fear Scale (CFS), the validity and reliability of which was conducted by Gerçeker et al. (2018), is used to measure the child's anxiety level. The PSS is a 0-4 scale consisting of five drawn facial expressions ranging from neutral expression (0=no anxiety) to scared face (4=severe anxiety). It can be used by families and researchers to assess pain and anxiety in children before and during the procedure and is intended for children aged 5-10 years (McMurtry et al., 2011). The CQS was created based on the Faces Anxiety Scale developed by McKinley et al. (2003) to measure the fear or anxiety of adults hospitalized in the intensive care unit. It is a scale consisting of one item and five gender-neutral faces. The facial muscle changes in fearful expressions were drawn by a graphic artist based on photographs of the faces. For the ACS, the total size of the Faces Anxiety Scale was reduced to match the size of the Child Anxiety and Pain Scale, but the drawings were not changed.

    Time frame: Baseline (upon arrival) and immediately before the clinical encounter (after multisensory stimulation).

07

Study locations

1 site
  • Bilecik Seyh Edebali University
    Bilecik, Turkey, Turkey (Türkiye)
08

References and documents

Publications

  • No publications resulting from this study are available at this time as the trial is currently ongoing.

Individual participant data

Plan to share: No — 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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2025 (actual). Primary completion is estimated for Aug 2026, 10 months after the start.

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

Registered
Aug 10, 2026
First posted
Aug 18, 2026
StartActual
Oct 1, 2025
Primary completionEst.
Aug 15, 2026
CompletionEst.
Sep 1, 2026
Last update
Aug 19, 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 Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07769775
Lead sponsor
Bilecik Seyh Edebali Universitesi
Responsible party
Fulya Kos (Assis Prof Dr, Bilecik Seyh Edebali Universitesi) — Principal investigator
First posted
Aug 18, 2026
Start date
Oct 1, 2025
Primary completion
Aug 15, 2026 (estimated)
Completion
Sep 1, 2026 (estimated)
Last update
Aug 19, 2026

Oversight

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

Not currently enrolling

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

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