Procedural PainNCT07319806
The Effect of Two Different Interventions on Emotional State, Pain, and Fear During Respiratory Panel Removal in Children: A Randomized Controlled Study
A study testing Palm Stimulator and Stress Ball in people with Procedural Pain and Fear Anxiety, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
Respiratory panel collection is a commonly used diagnostic procedure in children with suspected respiratory tract infections; however, it is often perceived as painful and distressing. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Procedural Pain, Fear Anxiety, Children
- What is being tested?
- Palm Stimulator and Stress Ball
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6 to 12 years
- Hospitalized children scheduled for respiratory panel specimen collection
- Ability to communicate verbally, understand instructions, and follow commands
- Children not receiving sedative, anticonvulsant, or analgesic medications at the time of the procedure
- Written informed consent obtained from a parent or legal guardian
- Assent obtained from the child
- Willingness of the child and parent/legal guardian to participate in the study
Who cannot join
- Children who do not consent or assent to participate
- Children requiring more than one attempt for respiratory panel specimen collection
- Presence of chronic, acute, or life-threatening medical conditions
- Children with cognitive or communication impairments that prevent reliable assessment
- Children with dependence on electronic or technological devices that may interfere with the intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Respiratory panel collection is a commonly used diagnostic procedure in children with suspected respiratory tract infections; however, it is often perceived as painful and distressing. Inadequately managed pain and fear during such procedures may negatively affect children's emotional responses to future medical interventions.
This randomized controlled trial aims to evaluate and compare the effects of two non-pharmacological interventions-a palm stimulator and a stress ball-on pain, fear, and emotional behavior in children aged 6-12 years undergoing respiratory panel specimen collection. Participants will be randomly assigned to one of three groups: palm stimulator intervention, stress ball intervention, or routine care (control group).
Pain, fear, and emotional responses will be assessed using validated pediatric measurement tools before, during, and after the procedure. The findings of this study are expected to contribute evidence on simple, practical, and developmentally appropriate non-pharmacological strategies that can be safely integrated into pediatric nursing practice to improve children's procedural experiences.
Read the detailed description
Procedural pain and fear are common challenges in pediatric clinical settings, particularly during invasive diagnostic procedures such as respiratory panel specimen collection. Children's negative emotional and behavioral responses during such procedures may lead to heightened distress, increased procedural resistance, and long-term fear of medical interventions. Therefore, the implementation of effective, safe, and developmentally appropriate non-pharmacological interventions is a priority in pediatric care.
This randomized controlled trial is designed to examine the comparative effectiveness of two tactile-based non-pharmacological interventions-a palm stimulator and a stress ball-on pain intensity, fear levels, and emotional behavior in children aged 6 to 12 years undergoing respiratory panel collection. The study adopts a parallel-group design with three arms: palm stimulator intervention, stress ball intervention, and routine care as the control condition.
Participants who meet the eligibility criteria will be randomly allocated to one of the three groups using a computer-generated randomization process. All respiratory panel specimen collections will be performed by the same trained pediatric nurse to minimize procedural variability. The interventions will be applied only during the specimen collection procedure, without altering standard clinical practice.
Pain, fear, and emotional responses will be assessed using validated pediatric measurement tools. Emotional behavior will be evaluated through structured behavioral observation before and after the procedure, while pain and fear will be assessed shortly after completion of the specimen collection. Assessments will be conducted by healthcare professionals who are not involved in the intervention delivery to reduce assessment bias.
By comparing two simple, low-cost, and easily applicable interventions with routine care, this study aims to generate evidence that can inform pediatric nursing practice and support the integration of non-pharmacological pain and fear management strategies into routine clinical procedures.
- Conditions
- Procedural Pain, Fear Anxiety, Children
- Being tested
- Palm Stimulator, Stress Ball
- Keywords
- Procedural Pain, Fear and Anxiety in Children, Palm Stimulator, Stress Ball, Emotional Behavior, Distraction Techniques, Pediatric Nursing
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palm StimulatorBehavioural
Children will be instructed to hold the palm stimulator in the palm of their hand during the respiratory panel specimen collection procedure and to squeeze/grip it throughout the procedure as a tactile distraction strategy. The palm stimulator will be used only during the procedure and removed immediately after completion.
Stress BallBehavioural
Children will be given a stress ball during the respiratory panel specimen collection procedure and will be instructed to repeatedly squeeze and release the ball throughout the procedure as an active distraction technique (e.g., counting while squeezing). The stress ball will be used only during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Palm Stimulator Intervention | Experimental | Participants in this arm will hold a palm stimulator device in their hand during the respiratory panel specimen collection procedure. The device provides tactile stimulation through surface protrusions designed to activate sensory input. The palm stimulator will be used only during the procedure and removed immediately after completion. Receives: Behavioral: Palm Stimulator |
| Stress Ball Intervention | Experimental | Participants in this arm will be provided with a stress ball during the respiratory panel specimen collection procedure. Children will be instructed to squeeze and release the stress ball repeatedly throughout the procedure as a distraction technique. The stress ball will be used only during the procedure. Receives: Behavioral: Stress Ball |
| Routine Care Control Group | No intervention | Participants in this arm will receive routine care during the respiratory panel specimen collection procedure without the use of any additional non-pharmacological intervention. Standard clinical practices, including caregiver presence and verbal reassurance, will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity During Respiratory Panel Collection
Pain intensity will be assessed using the Wong-Baker FACES Pain Rating Scale. Children will rate the maximum level of pain experienced during the respiratory panel specimen collection procedure shortly after completion of the procedure. Higher scores indicate greater pain intensity.
Measured: Within 5 minutes after completion of the respiratory panel specimen collection
Fear Level During Respiratory Panel Collection
Fear level will be measured using the Children's Fear Scale (CFS). Children will self-report their level of fear related to the respiratory panel specimen collection immediately after the procedure. Higher scores reflect greater fear.
Measured: Within 5 minutes after completion of the respiratory panel specimen collection
Emotional Behavioral Response During Respiratory Panel Collection
Emotional behavioral responses will be evaluated using the Children's Emotional Manifestation Scale. Behavioral observations will be conducted by a blinded outcome assessor before and after the respiratory panel specimen collection. Higher total scores indicate more negative emotional and behavioral responses.
Measured: From 2-3 minutes before the procedure to 2-3 minutes after completion of the respiratory panel specimen collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start15 May 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- 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 study uses a parallel-group randomized design in which eligible participants are assigned to one of three study arms: palm stimulator intervention, stress ball intervention, or routine care (control). Each participant receives only one intervention during the respiratory panel collection procedure and does not cross over to another group throughout the study period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özge Karakaya Suzan, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07319806
- Sponsor's protocol ID
- palm stimulator
- Status last verified
- Dec 2025
- First submitted
- 20 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Interventions on Emotional State, Pain, and Fear During Respiratory Panel Removal in Children: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07319806
- Acronym / sponsor ID
- palm stimulator
- Conditions
- Procedural Pain, Fear Anxiety, Children
- Keywords
- Procedural Pain, Fear and Anxiety in Children, Palm Stimulator, Stress Ball, Emotional Behavior, Distraction Techniques, Pediatric Nursing
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 6 Jan 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.
Respiratory panel collection is a commonly used diagnostic procedure in children with suspected respiratory tract infections; however, it is often perceived as painful and distressing. Inadequately managed pain and fear during such procedures may negatively affect children's emotional responses to future medical interventions.
This randomized controlled trial aims to evaluate and compare the effects of two non-pharmacological interventions-a palm stimulator and a stress ball-on pain, fear, and emotional behavior in children aged 6-12 years undergoing respiratory panel specimen collection. Participants will be randomly assigned to one of three groups: palm stimulator intervention, stress ball intervention, or routine care (control group).
Pain, fear, and emotional responses will be assessed using validated pediatric measurement tools before, during, and after the procedure. The findings of this study are expected to contribute evidence on simple, practical, and developmentally appropriate non-pharmacological strategies that can be safely integrated into pediatric nursing practice to improve children's procedural experiences.
Detailed description
Procedural pain and fear are common challenges in pediatric clinical settings, particularly during invasive diagnostic procedures such as respiratory panel specimen collection. Children's negative emotional and behavioral responses during such procedures may lead to heightened distress, increased procedural resistance, and long-term fear of medical interventions. Therefore, the implementation of effective, safe, and developmentally appropriate non-pharmacological interventions is a priority in pediatric care.
This randomized controlled trial is designed to examine the comparative effectiveness of two tactile-based non-pharmacological interventions-a palm stimulator and a stress ball-on pain intensity, fear levels, and emotional behavior in children aged 6 to 12 years undergoing respiratory panel collection. The study adopts a parallel-group design with three arms: palm stimulator intervention, stress ball intervention, and routine care as the control condition.
Participants who meet the eligibility criteria will be randomly allocated to one of the three groups using a computer-generated randomization process. All respiratory panel specimen collections will be performed by the same trained pediatric nurse to minimize procedural variability. The interventions will be applied only during the specimen collection procedure, without altering standard clinical practice.
Pain, fear, and emotional responses will be assessed using validated pediatric measurement tools. Emotional behavior will be evaluated through structured behavioral observation before and after the procedure, while pain and fear will be assessed shortly after completion of the specimen collection. Assessments will be conducted by healthcare professionals who are not involved in the intervention delivery to reduce assessment bias.
By comparing two simple, low-cost, and easily applicable interventions with routine care, this study aims to generate evidence that can inform pediatric nursing practice and support the integration of non-pharmacological pain and fear management strategies into routine clinical procedures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This study uses a parallel-group randomized design in which eligible participants are assigned to one of three study arms: palm stimulator intervention, stress ball intervention, or routine care (control). Each participant receives only one intervention during the respiratory panel collection procedure and does not cross over to another group throughout the study period.
| Arm | Type | Receives |
|---|---|---|
| Palm Stimulator Intervention | Experimental | Behavioral: Palm StimulatorParticipants in this arm will hold a palm stimulator device in their hand during the respiratory panel specimen collection procedure. The device provides tactile stimulation through surface protrusions designed to activate sensory input. The palm stimulator will be used only during the procedure and removed immediately after completion. |
| Stress Ball Intervention | Experimental | Behavioral: Stress BallParticipants in this arm will be provided with a stress ball during the respiratory panel specimen collection procedure. Children will be instructed to squeeze and release the stress ball repeatedly throughout the procedure as a distraction technique. The stress ball will be used only during the procedure. |
| Routine Care Control Group | No intervention | –Participants in this arm will receive routine care during the respiratory panel specimen collection procedure without the use of any additional non-pharmacological intervention. Standard clinical practices, including caregiver presence and verbal reassurance, will be applied. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children aged 6 to 12 years
- Hospitalized children scheduled for respiratory panel specimen collection
- Ability to communicate verbally, understand instructions, and follow commands
- Children not receiving sedative, anticonvulsant, or analgesic medications at the time of the procedure
- Written informed consent obtained from a parent or legal guardian
Key exclusion criteria (5 listed)
- Children who do not consent or assent to participate
- Children requiring more than one attempt for respiratory panel specimen collection
- Presence of chronic, acute, or life-threatening medical conditions
- Children with cognitive or communication impairments that prevent reliable assessment
- Children with dependence on electronic or technological devices that may interfere with the intervention
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 |
|---|---|---|
| Palm StimulatorChildren will be instructed to hold the palm stimulator in the palm of their hand during the respiratory panel specimen collection procedure and to squeeze/grip it throughout the procedure as a tactile distraction strategy. The palm stimulator will be used only during the procedure and removed immediately after completion. | Behavioural | Palm Stimulator Intervention |
| Stress BallChildren will be given a stress ball during the respiratory panel specimen collection procedure and will be instructed to repeatedly squeeze and release the ball throughout the procedure as an active distraction technique (e.g., counting while squeezing). The stress ball will be used only during the procedure. | Behavioural | Stress Ball Intervention |
Primary outcome
Pain Intensity During Respiratory Panel Collection
Time frame: Within 5 minutes after completion of the respiratory panel specimen collection
Pain intensity will be assessed using the Wong-Baker FACES Pain Rating Scale. Children will rate the maximum level of pain experienced during the respiratory panel specimen collection procedure shortly after completion of the procedure. Higher scores indicate greater pain intensity.
Fear Level During Respiratory Panel Collection
Time frame: Within 5 minutes after completion of the respiratory panel specimen collection
Fear level will be measured using the Children's Fear Scale (CFS). Children will self-report their level of fear related to the respiratory panel specimen collection immediately after the procedure. Higher scores reflect greater fear.
Emotional Behavioral Response During Respiratory Panel Collection
Time frame: From 2-3 minutes before the procedure to 2-3 minutes after completion of the respiratory panel specimen collection
Emotional behavioral responses will be evaluated using the Children's Emotional Manifestation Scale. Behavioral observations will be conducted by a blinded outcome assessor before and after the respiratory panel specimen collection. Higher total scores indicate more negative emotional and behavioral responses.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- 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.
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 Palm Stimulator and Stress Ball in people with Procedural Pain and Fear Anxiety, run by Sakarya University 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 7 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 6 Jan 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?
This study is still under way. Results are not available in the source record yet.
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 Respiratory Panel Collection (time frame: Within 5 minutes after completion of the respiratory panel specimen collection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2026.