Immunisation Anxiety Related ReactionNCT04103801
Substance P as a Biomarker to Evaluate the Reduction of Multiple Immunization Pain
A study testing Sucrose in people with Immunisation Anxiety Related Reaction and Pain, Acute, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial summary
Immunization is one of the most significant preventive health measures in reducing morbidity and mortality caused by infectious diseases. Studies have shown that Sucrose is recommended to reduce pain associated with vaccination in neonates. Read more about this study
- Who is it for?
- Ages 10 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Immunisation Anxiety Related Reaction, Pain, Acute
- What is being tested?
- Sucrose
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteJordan
- Study dates
- 14 Jul 2017to 3 Apr 2018
- 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 10 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All healthy children who were attending immunization clinic to have their 10-24 month immunization were invited to this study
Who cannot join
- Exclusion criteria included children: whose parents choose to breastfeed during immunization, who have received an analgesia in the previous 24 hours including Paracetamol (so as not to affect the response to painful stimuli during immunization), who cannot receive their immunization due to the presence of immunization risk factors as determined by the immunization nurse, who are not able to receive a sugar solution, and whose parents refuse to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Substance P as a Biomarker to Evaluate the Reduction of Multiple Immunization Pain Among Infants and Toddlers: A Randomized Controlled Trial
Immunization is one of the most significant preventive health measures in reducing morbidity and mortality caused by infectious diseases. Studies have shown that Sucrose is recommended to reduce pain associated with vaccination in neonates. The main aim of the study was to determine the effectiveness of sucrose in reducing infant's pain outcomes during immunization among 10-24 month-old infants and toddlers.
- Conditions
- Immunisation Anxiety Related Reaction, Pain, Acute
- Being tested
- Sucrose
- Keywords
- Sucrose,, Substance P,, Pain,, Immunization.
- Medical subject headings
- Acute Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SucroseDietary supplement
Also called Sweet solution
Participants in the intervention group were given 2 ml dose of 50% sucrose solution and participants in the placebo group were given 2 ml dose of sterile water. Both groups were administered slowly over 30 seconds sublingually via needle-less syringe immediately prior to the immunization injections.
| Study group | Role | What they receive |
|---|---|---|
| Sucrose group | Experimental | This group received the 2 ml of sweet solution (sucrose) Receives: Dietary Supplement: Sucrose |
| Water group | Placebo comparator | This group received the 2 ml of water Receives: Dietary Supplement: Sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
MBPS
Modified Behavioral Pain Scale (MBPS) is a validated procedural uni-dimensional pain measurement tool that used to measure behavioral pain outcomes.
Measured: Change MBPS score from the start of injection and up to 3 minutes after immunization
Secondary outcomes (1)
Substance P (SP)
Change SP level as an indicator of pain and distress level. Saliva was collected from both intervention and placebo groups immediately after treatment in the same manner and similar time schedule. Saliva specimens was immediately cooled in ice and centrifuged at 10,000g at 4 C for 15 min to obtain the supernatant.
Measured: Change SP level from the start of injection and up to 3 minutes after immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start14 Jul 2017
- Primary completion20 Dec 2017
- Study completion3 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunisation Anxiety Related ReactionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manal K, PhD, Principal investigator, Jordan Uinversity of Sceince and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103801
- Sponsor's protocol ID
- 127-2015
- Status last verified
- Sep 2019
- First submitted
- 17 Oct 2018
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data is confidential and could not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substance P as a Biomarker to Evaluate the Reduction of Multiple Immunization Pain Among Infants and Toddlers: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04103801
- Acronym / sponsor ID
- 127-2015
- Conditions
- Immunisation Anxiety Related Reaction, Pain, Acute
- Keywords
- Sucrose,, Substance P,, Pain,, Immunization.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 14 Jul 2017 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 3 Apr 2018 (actual)
- First posted
- 25 Sep 2019 (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.
Immunization is one of the most significant preventive health measures in reducing morbidity and mortality caused by infectious diseases. Studies have shown that Sucrose is recommended to reduce pain associated with vaccination in neonates. The main aim of the study was to determine the effectiveness of sucrose in reducing infant's pain outcomes during immunization among 10-24 month-old infants and toddlers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sucrose group | Experimental | Dietary Supplement: SucroseThis group received the 2 ml of sweet solution (sucrose) |
| Water group | Placebo comparator | Dietary Supplement: SucroseThis group received the 2 ml of water |
Who may qualify
- Ages
- 10 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All healthy children who were attending immunization clinic to have their 10-24 month immunization were invited to this study
Key exclusion criteria (1 listed)
- Exclusion criteria included children: whose parents choose to breastfeed during immunization, who have received an analgesia in the previous 24 hours including Paracetamol (so as not to affect the response to painful stimuli during immunization), who cannot receive their immunization due to the presence of immunization risk factors as determined by the immunization nurse, who are not able to receive a sugar solution, and whose parents refuse to participate.
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 |
|---|---|---|
| SucroseAlso: Sweet solutionParticipants in the intervention group were given 2 ml dose of 50% sucrose solution and participants in the placebo group were given 2 ml dose of sterile water. Both groups were administered slowly over 30 seconds sublingually via needle-less syringe immediately prior to the immunization injections. | Dietary supplement | Sucrose group, Water group |
Primary outcome
MBPS
Time frame: Change MBPS score from the start of injection and up to 3 minutes after immunization
Modified Behavioral Pain Scale (MBPS) is a validated procedural uni-dimensional pain measurement tool that used to measure behavioral pain outcomes.
1 secondary outcome
Substance P (SP)
Time frame: Change SP level from the start of injection and up to 3 minutes after immunization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Individual participant dataSharing planned: No. The data is confidential and could not be shared.
Related trials for Immunisation Anxiety Related Reaction
Not yet recruiting
Media Orientation to Improve Childhood Vaccine Uptake and Address Parent and Caregivers Vaccine-related Anxiety: A Pilot Study
Anxiety, Vaccination Hesitancy
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.
Manal K, PhD principal investigator
Jordan Uinversity of Sceince and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sucrose in people with Immunisation Anxiety Related Reaction and Pain, Acute, run by Jordan University of Science and Technology at 1 site in Jordan.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 25 Sep 2019. 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 Jordan. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MBPS (time frame: Change MBPS score from the start of injection and up to 3 minutes after immunization). 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 25 Sep 2019.