Multisensory StimulationNCT07769775
The Effect of Multisensory Stimulation During Venipuncture on Pain, Anxiety, and Fear in Children
A study testing Multisensory stimulation in people with Multisensory Stimulation and Pain, run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Multisensory Stimulation, Pain, Venipuncture Pain
- What is being tested?
- Multisensory stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 1 Sep 2026
- 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 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Presence of visual or hearing impairment
- Presence of intellectual/cognitive disability
- Absence or lack of signed Parental Informed Consent Form
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bilecik Seyh Edebali University
Bilecik, Turkey
About this study
Official title: The Effect of Multisensory Stimulation During Venipuncture on Pain, Anxiety, and Fear in Children: A Randomized Controlled Trial
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.
- Conditions
- Multisensory Stimulation, Pain, Venipuncture Pain, Fear
- Being tested
- Multisensory stimulation
- Keywords
- child, pain, fear, anxiety, venipuncture, multisensory stimülation
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multisensory stimulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| The Effect of Multisensory Stimulation During Venipuncture on Pain, Anxiety, and Fear in Children | Experimental | A Randomized Controlled Trial Receives: Other: Multisensory stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (upon arrival) and immediately before the clinical encounter (after multisensory stimulation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start1 Oct 2025
- Primary completion15 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multisensory StimulationStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bilecik Seyh Edebali Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fulya Kos, Bilecik Seyh Edebali Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769775
- Sponsor's protocol ID
- Bilecik-BSEU2
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
No publications resulting from this study are available at this time as the trial is currently ongoing.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Multisensory Stimulation During Venipuncture on Pain, Anxiety, and Fear in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07769775
- Acronym / sponsor ID
- Bilecik-BSEU2
- Conditions
- Multisensory Stimulation, Pain, Venipuncture Pain, Fear
- Keywords
- child, pain, fear, anxiety, venipuncture, multisensory stimülation
- Study type
- Interventional
- Recruitment status
- SuspendedReason 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.
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Bilecik Seyh Edebali UniversitesiUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 18 Aug 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.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Effect of Multisensory Stimulation During Venipuncture on Pain, Anxiety, and Fear in Children | Experimental | Other: Multisensory stimulationA Randomized Controlled Trial |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Presence of visual or hearing impairment
- Presence of intellectual/cognitive disability
- Absence or lack of signed Parental Informed Consent Form
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 |
|---|---|---|
| Multisensory stimulationHappy 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. | Other | The Effect of Multisensory Stimulation During Venipuncture on Pain, Anxiety, and Fear in Children |
Primary outcome
Child's Pain Level
Time frame: Baseline (upon arrival) and immediately before the clinical encounter (after multisensory stimulation).
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.
1 secondary outcome
Child's Anxiety Level
Time frame: Baseline (upon arrival) and immediately before the clinical encounter (after multisensory stimulation).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Results publicationNo publications resulting from this study are available at this time as the trial is currently ongoing.
- Individual participant dataSharing planned: 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.
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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 Multisensory stimulation in people with Multisensory Stimulation and Pain, run by Bilecik Seyh Edebali Universitesi 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 3 inclusion and 3 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: paused, as of the sponsor's last update on 19 Aug 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?
Results are not available in the source record.
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?
Child's Pain Level (time frame: Baseline (upon arrival) and immediately before the clinical encounter (after multisensory stimulation).). 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 NCT07769775, which also lists 1 linked publication.
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 19 Aug 2026.