Placebo AnalgesiaNCT06313788
Applying a Small Procedure Prior to Injection/Vaccination Reduces Pain in Children
A study of Placebo Analgesia and Pediatric Pain, run by Lingnan University.
Trial summary
In this proposed study, the investigators aim to apply a minor procedure prior to a treatment that induces pain (e.g., injection/vaccination) to help manage pediatric pain. The proposed study builds on the well-known placebo effect, which occurs when individuals experience improvements in condition (e.g., pain relief)… Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Placebo Analgesia, Pediatric Pain, Vaccination
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 8 Oct 2026to 1 Jan 2028
- 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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6 to 14 years;
- Scheduled to receive a routine vaccination through the school;
- Able to understand study instructions and provide self-reports of pain;
- Parent/guardian provides informed consent and the child provides assent.
Who cannot join
- Pre-existing pain or injury at the intended injection site;
- Known allergy or sensitivity to adhesive bandages;
- Significant visual, hearing, or cognitive impairments that would interfere with participation;
- Severe needle phobia or distress requiring special clinical management;
- Failure to comply with study procedures or provide valid responses.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Applying a Small Procedure Prior to Injection/Vaccination Reduces Pain in Children: A Randomized Controlled Trial
In this proposed study, the investigators aim to apply a minor procedure prior to a treatment that induces pain (e.g., injection/vaccination) to help manage pediatric pain.
The proposed study builds on the well-known placebo effect, which occurs when individuals experience improvements in condition (e.g., pain relief) after using an inert substance (e.g., a placebo analgesic). This effect is primarily attributed to expectations about the placebo's effectiveness. The investigators extend this line of research by demonstrating that, under certain circumstances, merely possessing a placebo can also lead to pain relief. This possession-based placebo analgesic effect arises from a sense of ownership, which enhances the expectation that the owned placebo can provide benefits to the self. This study expands the scope of the possession-based placebo effect by examining its applicability in a real-life situation - the investigators expect that providing children with ownership of a first-aid bandage before vaccination will improve the overall pain experience.
Focusing on children's pain is critical for several reasons. First, pain is a common experience for children, who are often less mature and independent than adults in assessing and managing it. This renders children a vulnerable population requiring improved pain management interventions. Unfortunately, pediatric pain recognition and treatment are still inadequate. Second, most past placebo analgesic studies have focused on adults, leading to significant knowledge gaps regarding implications for pediatric care. This knowledge gap is attributed to historical ethical and legal ambiguities that hindered randomized controlled trials involving children, resulting in exclusion from research. Third, research targeting children is essential to understand these unique circumstances and deliver appropriate benefits. The U.S. Department of Health and Human Services and the Food and Drug Administration have emphasized the need to broaden pediatric research participation. A recent motion by the Hong Kong Legislative Council on "Promoting the Development of Children's Healthcare Services" further highlights this commitment. Finally, age-related factors may influence individuals' pain outcomes or responses. Children are more susceptible to the placebo effect than adults; this may be due to the stronger influence of parental (compared to professional) expectations on pediatric pain perceptions. Thus, caution is needed when generalizing adult findings to children. Investigating pain in children is crucial for developing tailored interventions for the pediatric population. This project will allow healthcare practitioners and physicians to learn about the possibility of tailoring, forming, or optimizing medical intervention strategies to enhance positive pain outcomes and novel pain management. For instance, practitioners, clinicians, and dentists could consider tailoring therapeutic interactions and treatments by incorporating appropriate procedures to reduce undesired negative pain outcomes.
Read the detailed description
This study will employ a two-arm randomized controlled between-subjects design to examine whether possessing a placebo before an injection improves pediatric pain experiences. The study will collaborate with a primary school to recruit children in Grades 1-6 who are scheduled to receive routine vaccinations. The study will follow the procedures outlined below:
Pre-screening. Children aged 6 to 14 will be recruited, a developmental stage at which participants can provide meaningful self-reports of pain experiences. Eligible participants must be in good general health and scheduled for vaccinations. Exclusion criteria include pre-existing pain at the injection site, visual or auditory impairments, allergies to bandages, fear of needles, and non-compliance. Informed consent will be obtained from participants and legal guardians, who will be informed of all participant rights.
Randomization and waiting period. Randomization will be conducted at the classroom level within each primary school year, randomly allocating classes to either the Bandage Possession or No Possession condition. On the vaccination day, during the waiting period, participants will view a child-friendly cartoon illustration explaining the importance of vaccination and the benefits of an open-label placebo bandage.
Bandage possession group (Open-Label Placebo): Participants will receive a bandage featuring their preferred cartoon character and their names, fostering a sense of ownership. The bandage will be stored in a transparent plastic bag, creating a possession condition. Participants will anticipate how the bandage can ease the upcoming injection pain, inducing positive expectancy.
No possession group: Participants will not receive any object.
Before injection. Participants will be interviewed about their state fear of pain, emotional state, state anxiety, pain-coping self-efficacy, and pain-relief expectancy. The Face Pain Scale and Numeric Rating Scale will be adopted for estimating the intensity and unpleasantness of the upcoming injection pain, respectively.
Injection. All participants will undergo the standard vaccination procedure.
Post-injection. Immediately after the injection, participants will complete post-procedure assessments, including measures of pain intensity, pain unpleasantness, as well as the bandage's perceived effectiveness and manipulation checks.
The investigators expect that allowing children to possess a customized bandage (OLP) before the injection will enhance their pain experience compared to the no-possession group.
- Conditions
- Placebo Analgesia, Pediatric Pain, Vaccination
- Being tested
- Possession of a Customized Placebo Analgesia
- Keywords
- Children, Vaccination, Pediatric Pain, Placebo Effect, Mere Ownership Effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Possession of a Customized Placebo AnalgesiaOther
Participants in this open-label placebo (OLP) arm receive a band-aid customized with their preferred cartoon character and name inside a transparent plastic bag. Prior to vaccination, children hold and view the packaged bandage while receiving standardized verbal instructions explaining that although the bandage is not medicine and does not directly stop pain, possessing it may help them feel better and cope with the injection. Participants retain possession of the bandage without applying it to the skin.
| Study group | Role | What they receive |
|---|---|---|
| Band-aid possession group | Experimental | Participants in this open-label placebo (OLP) arm receive a band-aid customized with their preferred cartoon character and name inside a transparent plastic bag. Prior to vaccination, children hold and view the packaged bandage while receiving standardized verbal instructions explaining that although the bandage is not medicine and does not directly stop pain, possessing it may help them feel better and cope with the injection. Participants retain possession of the bandage without applying it to the skin. Receives: Other: Possession of a Customized Placebo Analgesia |
| No Possession Group | No intervention | Participants undergo standard vaccination waiting procedures without receiving or holding any object prior to the injection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective Post-Vaccination Pain Intensity Score
Assessed using the Revised Faces Pain Scale (FPS-R). The FPS-R is a validated pediatric self-report measure consisting of 6 facial expressions corresponding to pain scores of 0, 2, 4, 6, 8, and 10 (0 = "no pain", 10 = "very much pain"). Higher scores indicate higher retrospective pain intensity experienced during the injection.
Measured: Immediately post-injection (within 1 to 5 minutes following vaccination)
Retrospective Pain Unpleasantness Numeric Rating Scale (NRS) Score
Assessed using a 0 to 10 Numeric Rating Scale (NRS). The NRS ranges from 0 ("No unpleasantness") to 10 ("Extreme unpleasantness"). Participants rate the actual unpleasantness experienced during the injection. Higher scores indicate greater retrospective pain unpleasantness.
Measured: Immediately post-injection (within 1 to 5 minutes following vaccination)
Perceived Self-Efficacy for Pain Coping Score
Assessed using a 5-item self-efficacy scale. Participants rate their confidence in their ability to perform regular daily activities (e.g., finishing classes, playing with friends, doing homework) after receiving the injection. Items are rated on a 5-point scale ranging from 1 "No confidence" to 5 "Completely confident". Higher average scores indicate greater self-efficacy in coping with post-vaccination functioning.
Measured: Pre-injection and Immediately post-injection (within 1 to 5 minutes following vaccination)
Secondary outcomes (5)
Positive and Negative Affect
Assessed using a 6-item mood questionnaire asking participants to rate their current emotional state (e.g., shy, nervous, confident, focused, afraid, happy). Each item is rated on a 5-point Likert scale ranging from 1 "Not at all" to 5 "Extremely". Higher scores indicate a stronger presence of that affect.
Measured: Pre-injection
State Anxiety and Fear
Assessed using a 5-item scale measuring current feelings of anxiety and fear (e.g., feeling calm, tense, relaxed, worried, afraid). Participants rate each feeling on a 4-point scale ranging from 1 "Not at all" to 4 "Very obvious". Higher total scores indicate higher levels of state anxiety.
Measured: Pre-injection
Anticipated Pain Unpleasantness Numeric Rating Scale (NRS) Score
Assessed using a 0 to 10 Numeric Rating Scale (NRS), ranging from 0 "No unpleasantness" to 10 "Extreme unpleasantness". Participants rate the unpleasantness they anticipate during the upcoming injection. Higher scores indicate greater anticipated pain unpleasantness.
Measured: Pre-injection
Anticipated Pre-Vaccination Pain Intensity Score
Assessed using the Revised Faces Pain Scale (FPS-R), a validated pediatric self-report measure consisting of 6 facial expressions corresponding to pain scores of 0, 2, 4, 6, 8, and 10 (0 = 'no pain', 10 = 'very much pain'). Higher scores indicate greater anticipated pain intensity expected during the injection.
Measured: Pre-injection
Pain-relief expectancy regarding the upcoming vaccination
Assessed using a single-item expectancy measure. Participants rate their agreement with the statement that the bandage can help them feel more comfortable and experience less pain during the injection. Rated on a 5-point Likert scale ranging from 1 "Strongly disagree" to 5 "Strongly agree". Higher scores indicate stronger positive expectations of pain relief.
Measured: Pre-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start8 Oct 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Placebo AnalgesiaStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lingnan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeung Wai Lan Victoria, Lingnan University
- Investigators
- WAI LAN VICTORIA YEUNG, PhD, Principal investigator, Lingnan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313788
- Sponsor's protocol ID
- EC007-2324
- Status last verified
- Oct 2026
- First submitted
- 16 Feb 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data collected during the study will be made publicly available upon project completion. The dataset will be anonymized using participant participation codes to ensure confidentiality before being shared.
Publications
Legislative Council Meeting (2024). "Promoting the Development of Children's Healthcare Services" (Progress Report CB(3)256/2024(01).
Department of Health and Human Services U.S. Food and Drug Administration. (2001, January). The Pediatric Exclusivity Provision-January 2001 Status Report to Congress.
Gniss S, Kappesser J, Hermann C. Placebo effect in children: the role of expectation and learning. Pain. 2020 Jun;161(6):1191-1201. doi: 10.1097/j.pain.0000000000001811.
PubMed 31977929Park K, Tran NK, Momper JD, Green DJ, Burckart GJ. Pediatric and Adult Placebo Response Rates in Placebo-Controlled Clinical Trials Submitted to the US Food and Drug Administration 2012-2020. J Clin Pharmacol. 2022 Aug;62(8):970-982. doi: 10.1002/jcph.2035. Epub 2022 Mar 11.
PubMed 35118684Dresser R. Mentally disabled research subjects. The enduring policy issues. JAMA. 1996 Jul 3;276(1):67-72.
PubMed 8667543Yan EG, Munir KM. Regulatory and ethical principles in research involving children and individuals with developmental disabilities. Ethics Behav. 2004;14(1):31-49. doi: 10.1207/s15327019eb1401_3.
PubMed 15580725Weimer K, Gulewitsch MD, Schlarb AA, Schwille-Kiuntke J, Klosterhalfen S, Enck P. Placebo effects in children: a review. Pediatr Res. 2013 Jul;74(1):96-102. doi: 10.1038/pr.2013.66. Epub 2013 Apr 18.
PubMed 23598811Birnie KA, Chambers CT, Fernandez CV, Forgeron PA, Latimer MA, McGrath PJ, Cummings EA, Finley GA. Hospitalized children continue to report undertreated and preventable pain. Pain Res Manag. 2014 Jul-Aug;19(4):198-204. doi: 10.1155/2014/614784. Epub 2014 May 7.
PubMed 24809068
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying a Small Procedure Prior to Injection/Vaccination Reduces Pain in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06313788
- Acronym / sponsor ID
- EC007-2324
- Conditions
- Placebo Analgesia, Pediatric Pain, Vaccination
- Keywords
- Children, Vaccination, Pediatric Pain, Placebo Effect, Mere Ownership Effect
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Lingnan UniversityUniversity, hospital or other
- Study start
- 8 Oct 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 15 Mar 2024 (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.
In this proposed study, the investigators aim to apply a minor procedure prior to a treatment that induces pain (e.g., injection/vaccination) to help manage pediatric pain.
The proposed study builds on the well-known placebo effect, which occurs when individuals experience improvements in condition (e.g., pain relief) after using an inert substance (e.g., a placebo analgesic). This effect is primarily attributed to expectations about the placebo's effectiveness. The investigators extend this line of research by demonstrating that, under certain circumstances, merely possessing a placebo can also lead to pain relief. This possession-based placebo analgesic effect arises from a sense of ownership, which enhances the expectation that the owned placebo can provide benefits to the self. This study expands the scope of the possession-based placebo effect by examining its applicability in a real-life situation - the investigators expect that providing children with ownership of a first-aid bandage before vaccination will improve the overall pain experience.
Focusing on children's pain is critical for several reasons. First, pain is a common experience for children, who are often less mature and independent than adults in assessing and managing it. This renders children a vulnerable population requiring improved pain management interventions. Unfortunately, pediatric pain recognition and treatment are still inadequate. Second, most past placebo analgesic studies have focused on adults, leading to significant knowledge gaps regarding implications for pediatric care. This knowledge gap is attributed to historical ethical and legal ambiguities that hindered randomized controlled trials involving children, resulting in exclusion from research. Third, research targeting children is essential to understand these unique circumstances and deliver appropriate benefits. The U.S. Department of Health and Human Services and the Food and Drug Administration have emphasized the need to broaden pediatric research participation. A recent motion by the Hong Kong Legislative Council on "Promoting the Development of Children's Healthcare Services" further highlights this commitment. Finally, age-related factors may influence individuals' pain outcomes or responses. Children are more susceptible to the placebo effect than adults; this may be due to the stronger influence of parental (compared to professional) expectations on pediatric pain perceptions. Thus, caution is needed when generalizing adult findings to children. Investigating pain in children is crucial for developing tailored interventions for the pediatric population. This project will allow healthcare practitioners and physicians to learn about the possibility of tailoring, forming, or optimizing medical intervention strategies to enhance positive pain outcomes and novel pain management. For instance, practitioners, clinicians, and dentists could consider tailoring therapeutic interactions and treatments by incorporating appropriate procedures to reduce undesired negative pain outcomes.
Detailed description
This study will employ a two-arm randomized controlled between-subjects design to examine whether possessing a placebo before an injection improves pediatric pain experiences. The study will collaborate with a primary school to recruit children in Grades 1-6 who are scheduled to receive routine vaccinations. The study will follow the procedures outlined below:
Pre-screening. Children aged 6 to 14 will be recruited, a developmental stage at which participants can provide meaningful self-reports of pain experiences. Eligible participants must be in good general health and scheduled for vaccinations. Exclusion criteria include pre-existing pain at the injection site, visual or auditory impairments, allergies to bandages, fear of needles, and non-compliance. Informed consent will be obtained from participants and legal guardians, who will be informed of all participant rights.
Randomization and waiting period. Randomization will be conducted at the classroom level within each primary school year, randomly allocating classes to either the Bandage Possession or No Possession condition. On the vaccination day, during the waiting period, participants will view a child-friendly cartoon illustration explaining the importance of vaccination and the benefits of an open-label placebo bandage.
Bandage possession group (Open-Label Placebo): Participants will receive a bandage featuring their preferred cartoon character and their names, fostering a sense of ownership. The bandage will be stored in a transparent plastic bag, creating a possession condition. Participants will anticipate how the bandage can ease the upcoming injection pain, inducing positive expectancy.
No possession group: Participants will not receive any object.
Before injection. Participants will be interviewed about their state fear of pain, emotional state, state anxiety, pain-coping self-efficacy, and pain-relief expectancy. The Face Pain Scale and Numeric Rating Scale will be adopted for estimating the intensity and unpleasantness of the upcoming injection pain, respectively.
Injection. All participants will undergo the standard vaccination procedure.
Post-injection. Immediately after the injection, participants will complete post-procedure assessments, including measures of pain intensity, pain unpleasantness, as well as the bandage's perceived effectiveness and manipulation checks.
The investigators expect that allowing children to possess a customized bandage (OLP) before the injection will enhance their pain experience compared to the no-possession group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Band-aid possession group | Experimental | Other: Possession of a Customized Placebo AnalgesiaParticipants in this open-label placebo (OLP) arm receive a band-aid customized with their preferred cartoon character and name inside a transparent plastic bag. Prior to vaccination, children hold and view the packaged bandage while receiving standardized verbal instructions explaining that although the bandage is not medicine and does not directly stop pain, possessing it may help them feel better and cope with the injection. Participants retain possession of the bandage without applying it to the skin. |
| No Possession Group | No intervention | –Participants undergo standard vaccination waiting procedures without receiving or holding any object prior to the injection. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 6 to 14 years;
- Scheduled to receive a routine vaccination through the school;
- Able to understand study instructions and provide self-reports of pain;
- Parent/guardian provides informed consent and the child provides assent.
Key exclusion criteria (5 listed)
- Pre-existing pain or injury at the intended injection site;
- Known allergy or sensitivity to adhesive bandages;
- Significant visual, hearing, or cognitive impairments that would interfere with participation;
- Severe needle phobia or distress requiring special clinical management;
- Failure to comply with study procedures or provide valid responses.
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 |
|---|---|---|
| Possession of a Customized Placebo AnalgesiaParticipants in this open-label placebo (OLP) arm receive a band-aid customized with their preferred cartoon character and name inside a transparent plastic bag. Prior to vaccination, children hold and view the packaged bandage while receiving standardized verbal instructions explaining that although the bandage is not medicine and does not directly stop pain, possessing it may help them feel better and cope with the injection. Participants retain possession of the bandage without applying it to the skin. | Other | Band-aid possession group |
Primary outcome
Retrospective Post-Vaccination Pain Intensity Score
Time frame: Immediately post-injection (within 1 to 5 minutes following vaccination)
Assessed using the Revised Faces Pain Scale (FPS-R). The FPS-R is a validated pediatric self-report measure consisting of 6 facial expressions corresponding to pain scores of 0, 2, 4, 6, 8, and 10 (0 = "no pain", 10 = "very much pain"). Higher scores indicate higher retrospective pain intensity experienced during the injection.
Retrospective Pain Unpleasantness Numeric Rating Scale (NRS) Score
Time frame: Immediately post-injection (within 1 to 5 minutes following vaccination)
Assessed using a 0 to 10 Numeric Rating Scale (NRS). The NRS ranges from 0 ("No unpleasantness") to 10 ("Extreme unpleasantness"). Participants rate the actual unpleasantness experienced during the injection. Higher scores indicate greater retrospective pain unpleasantness.
Perceived Self-Efficacy for Pain Coping Score
Time frame: Pre-injection and Immediately post-injection (within 1 to 5 minutes following vaccination)
Assessed using a 5-item self-efficacy scale. Participants rate their confidence in their ability to perform regular daily activities (e.g., finishing classes, playing with friends, doing homework) after receiving the injection. Items are rated on a 5-point scale ranging from 1 "No confidence" to 5 "Completely confident". Higher average scores indicate greater self-efficacy in coping with post-vaccination functioning.
5 secondary outcomes
Positive and Negative Affect
Time frame: Pre-injection
State Anxiety and Fear
Time frame: Pre-injection
Anticipated Pain Unpleasantness Numeric Rating Scale (NRS) Score
Time frame: Pre-injection
Anticipated Pre-Vaccination Pain Intensity Score
Time frame: Pre-injection
Pain-relief expectancy regarding the upcoming vaccination
Time frame: Pre-injection
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 16 Oct 2026.
- BackgroundLegislative Council Meeting (2024). "Promoting the Development of Children's Healthcare Services" (Progress Report CB(3)256/2024(01).
- BackgroundDepartment of Health and Human Services U.S. Food and Drug Administration. (2001, January). The Pediatric Exclusivity Provision-January 2001 Status Report to Congress.
- Background: PubMed 31977929Gniss S, Kappesser J, Hermann C. Placebo effect in children: the role of expectation and learning. Pain. 2020 Jun;161(6):1191-1201. doi: 10.1097/j.pain.0000000000001811.
- Background: PubMed 35118684Park K, Tran NK, Momper JD, Green DJ, Burckart GJ. Pediatric and Adult Placebo Response Rates in Placebo-Controlled Clinical Trials Submitted to the US Food and Drug Administration 2012-2020. J Clin Pharmacol. 2022 Aug;62(8):970-982. doi: 10.1002/jcph.2035. Epub 2022 Mar 11.
- Background: PubMed 8667543Dresser R. Mentally disabled research subjects. The enduring policy issues. JAMA. 1996 Jul 3;276(1):67-72.
- Background: PubMed 15580725Yan EG, Munir KM. Regulatory and ethical principles in research involving children and individuals with developmental disabilities. Ethics Behav. 2004;14(1):31-49. doi: 10.1207/s15327019eb1401_3.
- Background: PubMed 23598811Weimer K, Gulewitsch MD, Schlarb AA, Schwille-Kiuntke J, Klosterhalfen S, Enck P. Placebo effects in children: a review. Pediatr Res. 2013 Jul;74(1):96-102. doi: 10.1038/pr.2013.66. Epub 2013 Apr 18.
- Background: PubMed 24809068Birnie KA, Chambers CT, Fernandez CV, Forgeron PA, Latimer MA, McGrath PJ, Cummings EA, Finley GA. Hospitalized children continue to report undertreated and preventable pain. Pain Res Manag. 2014 Jul-Aug;19(4):198-204. doi: 10.1155/2014/614784. Epub 2014 May 7.
- Individual participant dataSharing planned: Yes. De-identified individual participant data collected during the study will be made publicly available upon project completion. The dataset will be anonymized using participant participation codes to ensure confidentiality before being shared.
Related trials for Placebo Analgesia
Recruiting
Radio- KO Radiotherapy for Knee Osteoarthritis Clinical Trial
Osteoarthritis, Knee
Not yet recruitingPhase 2
Postsurgical Analgesia After Unilateral Bunionectomy
Bunionectomy, Bunion
Not yet recruitingPhase 4
Intravenous Dexamethasone for ESP Block Analgesia in Children Undergoing Idiopathic Scoliosis Surgery
Adolescent Idiopathic Scoliosis (AIS)
RecruitingPhase 2
Analgesic Efficacy and Safety of Topical VMD-3866 Gel in Management of Pain Induced by Chemotherapy (CIPN)
Chemotherapy-induced Peripheral Neuropathy, Chemotherapy-induced Neuropathic Pain
Enrolling by invitationPhase 3
A Clinical Trial Evaluating the Efficacy and Safety of Local Infiltration of RF16001 for Injection for Analgesia After Total Hip Arthroplasty in China
Pain After Abdominal Surgery
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.
WAI LAN VICTORIA YEUNG, PhD principal investigator
Lingnan University
Questions about this trial
What is this clinical trial studying?
A study of Placebo Analgesia and Pediatric Pain, run by Lingnan University.
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 4 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: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Ki Poon, Bachelor ((852) 6816 6795, kipoon@ln.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective Post-Vaccination Pain Intensity Score (time frame: Immediately post-injection (within 1 to 5 minutes following vaccination)). 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?
On the ClinicalTrials.gov record for NCT06313788, which also lists 8 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 16 Oct 2026.