PainNCT00720824
Reduction of Immunization Discomfort in Children
A study testing Topical anesthetic and hypnotic distraction and Office routine in people with Pain, run by Berberich, F. Ralph, M.D. at 1 site in United States.
Trial summary
A combination of topical anesthetic, plastic arm gripper, visual focusing task and hypnotic suggestions will reduce the discomfort associated with immunization of pre-kindergarten aged children. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Topical anesthetic and hypnotic distraction and Office routine
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Aug 2007
- 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All children ages 4-6 years scheduled to receive routine pre-kindergarten immunizations
Who cannot join
- Inability to follow verbal directions
- Significant concurrent illness
- Prior invasive procedures, excluding neonatal circumcision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction of Immunization Discomfort in 4-6 Year Old Children: A Randomized Clinical Trial.
A combination of topical anesthetic, plastic arm gripper, visual focusing task and hypnotic suggestions will reduce the discomfort associated with immunization of pre-kindergarten aged children.
Read the detailed description
Randomization of 42 children evaluated the method described above against an office routine control group.
- Conditions
- Pain
- Being tested
- Topical anesthetic and hypnotic distraction, Office routine
- Keywords
- Immunizations, Children, Injections, aged 4-6 Years, Hypnosis
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical anesthetic and hypnotic distractionBehavioural
Also called Wahl vibrator
Ethyl chloride spray, plastic arm gripper, vibrating instrument, hypnotic suggestions.
Office routineBehavioural
Standard vaccine administration
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Ethyl chloride spray, plastic arm gripper, vibrating instrument, hypnotic suggestions Receives: Behavioral: Topical anesthetic and hypnotic distraction |
| 2 | Placebo comparator | Office routine Receives: Behavioral: Office routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial Pain Scale and Faces-Legs-Activity-Cry-Consolability Scale measurements of degree of discomfort.
Measured: 10 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2008 (estimated)
- Study startJun 2007
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Berberich, F. Ralph, M.D.
- Investigators
- f. Ralph berberich, MD, Principal investigator, Pediatric Medial Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00720824
- Sponsor's protocol ID
- Berberich
- Status last verified
- Jul 2008
- First submitted
- 21 Jul 2008
- Last updated
- 23 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Immunization Discomfort in 4-6 Year Old Children: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT00720824
- Acronym / sponsor ID
- Berberich
- Conditions
- Pain
- Keywords
- Immunizations, Children, Injections, aged 4-6 Years, Hypnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Berberich, F. Ralph, M.D.
- Study start
- Jun 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 23 Jul 2008 (estimated)
- 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.
A combination of topical anesthetic, plastic arm gripper, visual focusing task and hypnotic suggestions will reduce the discomfort associated with immunization of pre-kindergarten aged children.
Detailed description
Randomization of 42 children evaluated the method described above against an office routine control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Topical anesthetic and hypnotic distractionEthyl chloride spray, plastic arm gripper, vibrating instrument, hypnotic suggestions |
| 2 | Placebo comparator | Behavioral: Office routineOffice routine |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children ages 4-6 years scheduled to receive routine pre-kindergarten immunizations
Key exclusion criteria (3 listed)
- Inability to follow verbal directions
- Significant concurrent illness
- Prior invasive procedures, excluding neonatal circumcision
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 |
|---|---|---|
| Topical anesthetic and hypnotic distractionAlso: Wahl vibratorEthyl chloride spray, plastic arm gripper, vibrating instrument, hypnotic suggestions. | Behavioural | 1 |
| Office routineStandard vaccine administration | Behavioural | 2 |
Primary outcome
Facial Pain Scale and Faces-Legs-Activity-Cry-Consolability Scale measurements of degree of discomfort.
Time frame: 10 Minutes
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 23 Jul 2008.
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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.
f. Ralph berberich, MD principal investigator
Pediatric Medial Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical anesthetic and hypnotic distraction and Office routine in people with Pain, run by Berberich, F. Ralph, M.D. at 1 site in United States.
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 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: finished, as of the sponsor's last update on 23 Jul 2008. 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 United States. 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?
Facial Pain Scale and Faces-Legs-Activity-Cry-Consolability Scale measurements of degree of discomfort. (time frame: 10 Minutes). 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 23 Jul 2008.