PainNCT04436185
Effectiveness of Different Non-pharmacological Methods in Pain Management During Vaccination.
A study testing Comparisons of procedural pain in people with Pain, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Aim: This study was conducted to determine and compare the effectiveness of different non-pharmacological methods in pain management during vaccination. Methods: This randomized experimental study with placebo and control groups was conducted with 175 infants assigned to the ShotBlocker® (n = 35), ShotBlocker®-placebo… Read more about this study
- Who is it for?
- Ages Up to 8 weeksHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Comparisons of procedural pain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2019to 30 Sep 2019
- 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 Up to 8 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Born at full term
- No infection, redness, deteriorated skin integrity, or nerve damage in the area of application
- Had not undergone any clinical injection.
Who cannot join
- Infants who have applied analgesics before the vaccination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conducted to Determine and Compare the Effectiveness of Different Non-pharmacological Methods in Pain Management During Vaccination.
Aim: This study was conducted to determine and compare the effectiveness of different non-pharmacological methods in pain management during vaccination.
Methods: This randomized experimental study with placebo and control groups was conducted with 175 infants assigned to the ShotBlocker® (n = 35), ShotBlocker®-placebo (n = 35), sucrose (n = 35), sucrose-placebo (n = 35) and control (n = 35) groups. The pain levels of the infants were determined by blind assessors (nurses, parents, and observer) using the Neonatal Infant Pain Scale (NIPS) before and during vaccination.
- Conditions
- Pain
- Being tested
- Comparisons of procedural pain
- Keywords
- pain, infants
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparisons of procedural painBehavioural
This randomized experimental study with placebo and control groups
| Study group | Role | What they receive |
|---|---|---|
| Characteristics of newborns included | No intervention | Characteristics of newborns included in the randomized controll |
| Intraclass Correlation between the NIPS Score of Parent, Nurse | Experimental | Intraclass Correlation between the NIPS Score of Parent, Nurse Receives: Behavioral: Comparisons of procedural pain |
| Comparisons of procedural pain scores among groups | Experimental | Comparisons of procedural pain scores among groups Receives: Behavioral: Comparisons of procedural pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Infant Pain Scale (NIPS)
NIPS is a valid behavioural instrument that can be used to assess infants' response to pain. NIPS includes six behavioural responses to pain: facial expression, crying, breathing patterns, arms, legs, and state of wakefulness. The total pain scores range from 0 to 7. While the internal consistency of the original NIPS is within the range of .87 to .95, the internal consistency of the Turkish version is .83
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 posted17 Jun 2020
- Study start1 Jul 2019
- Primary completion30 Aug 2019
- Study completion30 Sep 2019
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.
- More trials run by Inonu 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was designed as a randomized experimental study with placebo and control groups in order to compare the effects of ShotBlocker® and sucrose on pain reduction during vaccine injections.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emriye Hilal Yayan, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436185
- Sponsor's protocol ID
- interventional
- Status last verified
- Jun 2020
- First submitted
- 16 Jun 2020
- Last updated
- 17 Jun 2020
- 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 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conducted to Determine and Compare the Effectiveness of Different Non-pharmacological Methods in Pain Management During Vaccination.
- ClinicalTrials.gov ID
- NCT04436185
- Acronym / sponsor ID
- interventional
- Conditions
- Pain
- Keywords
- pain, infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 17 Jun 2020 (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.
Aim: This study was conducted to determine and compare the effectiveness of different non-pharmacological methods in pain management during vaccination.
Methods: This randomized experimental study with placebo and control groups was conducted with 175 infants assigned to the ShotBlocker® (n = 35), ShotBlocker®-placebo (n = 35), sucrose (n = 35), sucrose-placebo (n = 35) and control (n = 35) groups. The pain levels of the infants were determined by blind assessors (nurses, parents, and observer) using the Neonatal Infant Pain Scale (NIPS) before and during vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This study was designed as a randomized experimental study with placebo and control groups in order to compare the effects of ShotBlocker® and sucrose on pain reduction during vaccine injections.
| Arm | Type | Receives |
|---|---|---|
| Characteristics of newborns included | No intervention | –Characteristics of newborns included in the randomized controll |
| Intraclass Correlation between the NIPS Score of Parent, Nurse | Experimental | Behavioral: Comparisons of procedural painIntraclass Correlation between the NIPS Score of Parent, Nurse |
| Comparisons of procedural pain scores among groups | Experimental | Behavioral: Comparisons of procedural painComparisons of procedural pain scores among groups |
Who may qualify
- Ages
- Up to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Born at full term
- No infection, redness, deteriorated skin integrity, or nerve damage in the area of application
- Had not undergone any clinical injection.
Key exclusion criteria (1 listed)
- Infants who have applied analgesics before the vaccination
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 |
|---|---|---|
| Comparisons of procedural painThis randomized experimental study with placebo and control groups | Behavioural | Comparisons of procedural pain scores among groups, Intraclass Correlation between the NIPS Score of Parent, Nurse |
Primary outcome
Neonatal Infant Pain Scale (NIPS)
Time frame: 10 minutes
NIPS is a valid behavioural instrument that can be used to assess infants' response to pain. NIPS includes six behavioural responses to pain: facial expression, crying, breathing patterns, arms, legs, and state of wakefulness. The total pain scores range from 0 to 7. While the internal consistency of the original NIPS is within the range of .87 to .95, the internal consistency of the Turkish version is .83
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 17 Jun 2020.
- 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. 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 Comparisons of procedural pain in people with Pain, run by Inonu 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 3 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 17 Jun 2020. 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?
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?
Neonatal Infant Pain Scale (NIPS) (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 17 Jun 2020.